Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus (PIONEER 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02863328
Recruitment Status : Completed
First Posted : August 11, 2016
Results First Posted : December 24, 2019
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: semaglutide
Drug: empagliflozin
Enrollment 822
Recruitment Details The trial was conducted at 108 sites in 12 countries as follows: Argentina (4), Brazil (3), Croatia (4), Greece (7), Hungary (7), Italy (5), Poland (6), Russian Federation (6), Serbia (5), Spain (8), Thailand (3), United States (46). 1 site each in Croatia and Italy, and 2 sites in the United States screened, but didn't randomise any subjects.
Pre-assignment Details Data presented in “participant flow” is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Period Title: Overall Study
Started [1] 411 410
Full Analysis Set (FAS) 411 410
Safety Analysis Set (SAS) 410 409
Completed 400 387
Not Completed 11 23
Reason Not Completed
Lost to Follow-up             4             10
Withdrawal by Subject             7             12
Died             0             1
[1]
One participant was duplicate, hence removed from 'started' population.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg Total
Hide Arm/Group Description Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52. Total of all reporting groups
Overall Number of Baseline Participants 411 410 821
Hide Baseline Analysis Population Description
FAS comprised of all randomised participants; however, one subject was randomised twice and thereby only included in FAS once.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 411 participants 410 participants 821 participants
57  (10) 58  (10) 58  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 411 participants 410 participants 821 participants
Female
205
  49.9%
201
  49.0%
406
  49.5%
Male
206
  50.1%
209
  51.0%
415
  50.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 411 participants 410 participants 821 participants
Hispanic or Latino
91
  22.1%
108
  26.3%
199
  24.2%
Not Hispanic or Latino
320
  77.9%
302
  73.7%
622
  75.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 411 participants 410 participants 821 participants
White
355
  86.4%
353
  86.1%
708
  86.2%
Black or African American
26
   6.3%
33
   8.0%
59
   7.2%
Asian
28
   6.8%
21
   5.1%
49
   6.0%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Other
2
   0.5%
3
   0.7%
5
   0.6%
[1]
Measure Description: Race
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 411 participants 410 participants 821 participants
8.1  (0.9) 8.1  (0.9) 8.1  (0.9)
1.Primary Outcome
Title Change in HbA1c
Hide Description Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Mean (Standard Deviation)
Unit of Measure: Percentage-point of HbA1c
In-trial Number Analyzed 392 participants 395 participants
-1.3  (1.1) -0.9  (0.9)
On-treatment without rescue medication Number Analyzed 347 participants 378 participants
-1.5  (1.1) -0.9  (0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Semaglutide 14 mg, Empagliflozin 25 mg
Comments The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.
Type of Statistical Test Non-Inferiority
Comments This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.
Statistical Test of Hypothesis P-Value < 0.0001
Comments Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.
Method Pattern mixture model
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.6 to -0.3
Estimation Comments Oral semaglutide 14 mg - Empagliflozin 25 mg
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Semaglutide 14 mg, Empagliflozin 25 mg
Comments The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.
Type of Statistical Test Superiority
Comments This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).
Statistical Test of Hypothesis P-Value < 0.0001
Comments Unadjusted two-sided p-value for test of no difference from 0 (superiority).
Method Pattern mixture model
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.6 to -0.3
Estimation Comments Oral semaglutide 14 mg - Empagliflozin 25 mg
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Oral Semaglutide 14 mg, Empagliflozin 25 mg
Comments The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.
Type of Statistical Test Non-Inferiority
Comments This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).
Statistical Test of Hypothesis P-Value <0.0001
Comments Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-0.7 to -0.4
Estimation Comments Oral semaglutide 14 mg - Empagliflozin 25 mg
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Oral Semaglutide 14 mg, Empagliflozin 25 mg
Comments The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.
Type of Statistical Test Superiority
Comments This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).
Statistical Test of Hypothesis P-Value <0.0001
Comments Unadjusted two-sided p-value for test of no difference from 0 (superiority).
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-0.7 to -0.4
Estimation Comments Oral semaglutide 14 mg - Empagliflozin 25 mg
2.Secondary Outcome
Title Change in Body Weight (Kg)
Hide Description Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Mean (Standard Deviation)
Unit of Measure: Kilogram (Kg)
In-trial Number Analyzed 393 participants 396 participants
-3.9  (4.4) -3.8  (3.8)
On-treatment without rescue medication Number Analyzed 348 participants 378 participants
-4.3  (4.4) -3.9  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Semaglutide 14 mg, Empagliflozin 25 mg
Comments The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.
Type of Statistical Test Superiority
Comments This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).
Statistical Test of Hypothesis P-Value = 0.7593
Comments Unadjusted two-sided p-value for test of no difference from 0 (superiority).
Method Pattern mixture model
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.7 to 0.5
Estimation Comments Oral semaglutide 14 mg - Empagliflozin 25 mg
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Semaglutide 14 mg, Empagliflozin 25 mg
Comments The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.
Type of Statistical Test Superiority
Comments This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).
Statistical Test of Hypothesis P-Value = 0.1358
Comments Unadjusted two-sided p-value for test of no difference from 0 (superiority).
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.0 to 0.1
Estimation Comments Oral semaglutide 14 mg - Empagliflozin 25 mg
3.Secondary Outcome
Title Change in HbA1c (%)
Hide Description Change from baseline (week 0) in HbA1c was evaluated at week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 384 382
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c
-1.3  (1.2) -0.9  (1.0)
4.Secondary Outcome
Title Change in Body Weight (kg)
Hide Description Change from baseline (week 0) in body weight was evaluated at week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 386 383
Mean (Standard Deviation)
Unit of Measure: Kg
-4.0  (5.5) -3.7  (4.3)
5.Secondary Outcome
Title Change in Fasting Plasma Glucose
Hide Description Change from baseline (week 0) in fasting plasma glucose was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
Week 26 Number Analyzed 388 participants 391 participants
-2.01  (2.56) -2.08  (2.17)
Week 52 Number Analyzed 380 participants 378 participants
-2.04  (2.50) -2.14  (2.36)
6.Secondary Outcome
Title Change in SMPG : Mean of the 7-point Profile
Hide Description Change from baseline (week 0) in mean of the 7-point self-measured plasma glucose (SMPG) (i.e. before and after breakfast, lunch and dinner, and at bedtime) profile was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Mean (Standard Deviation)
Unit of Measure: mmol/L
Week 26 Number Analyzed 351 participants 351 participants
-2.3  (2.1) -1.9  (2.1)
Week 52 Number Analyzed 334 participants 349 participants
-2.3  (2.3) -2.1  (2.3)
7.Secondary Outcome
Title Change in SMPG : Mean Postprandial Increment Over All Meals
Hide Description Change from baseline (week 0) in mean postprandial glucose increment was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Mean (Standard Deviation)
Unit of Measure: mmol/L
Week 26 Number Analyzed 351 participants 354 participants
-0.5  (1.8) -0.4  (2.0)
Week 52 Number Analyzed 335 participants 350 participants
-0.6  (1.8) -0.4  (1.9)
8.Secondary Outcome
Title Change in Fasting C-peptide (Ratio to Baseline)
Hide Description Change from baseline (week 0) in fasting C-peptide (Nanomoles per liter [nmol/L]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of C-peptide
week 26 Number Analyzed 381 participants 387 participants
1.10
(35.7%)
0.89
(29.4%)
week 52 Number Analyzed 377 participants 381 participants
1.09
(37.2%)
0.92
(31.6%)
9.Secondary Outcome
Title Change in Fasting Insulin (Ratio to Baseline)
Hide Description Change from baseline (week 0) in fasting insulin (picomoles per liter [pmol/L]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of insulin
Week 26 Number Analyzed 379 participants 386 participants
1.06
(50.5%)
0.77
(54.1%)
Week 52 Number Analyzed 376 participants 378 participants
1.03
(52.8%)
0.77
(53.7%)
10.Secondary Outcome
Title Change in Fasting Pro-insulin (Ratio to Baseline)
Hide Description Change from baseline (week 0) in fasting pro-insulin (pmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of pro-insulin
Week 26 Number Analyzed 383 participants 388 participants
0.72
(74.6%)
0.66
(61.9%)
Week 52 Number Analyzed 377 participants 377 participants
0.74
(80.5%)
0.69
(57.8%)
11.Secondary Outcome
Title Change in Fasting Glucagon (Ratio to Baseline)
Hide Description Change from baseline (week 0) in fasting glucagon (picograms per milliliter [pg/mL]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of glucagon
Week 26 Number Analyzed 385 participants 383 participants
0.91
(28.0%)
1.01
(27.5%)
Week 52 Number Analyzed 377 participants 376 participants
0.89
(27.8%)
0.95
(27.6%)
12.Secondary Outcome
Title Change in HOMA-IR (Ratio to Baseline)
Hide Description Change from baseline (week 0) in homeostatic model assessment index of insulin resistance (HOMA-IR) (%) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of HOMA-IR
Week 26 Number Analyzed 376 participants 383 participants
0.83
(63.8%)
0.61
(58.7%)
Week 52 Number Analyzed 374 participants 374 participants
0.81
(64.9%)
0.60
(60.4%)
13.Secondary Outcome
Title Change in HOMA-B (Ratio to Baseline)
Hide Description Change from baseline (week 0) in homeostatic model assessment index of beta-cell function (HOMA-B) (%) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of HOMA-B
Week 26 Number Analyzed 376 participants 383 participants
1.67
(69.5%)
1.16
(65.0%)
Week 52 Number Analyzed 374 participants 374 participants
1.66
(72.9%)
1.17
(69.9%)
14.Secondary Outcome
Title Change in C-reactive Protein (Ratio to Baseline)
Hide Description Change from baseline (week 0) in C-reactive protein (milligrams per liter [mg/L]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of C-reactive protein
Week 26 Number Analyzed 388 participants 395 participants
0.69
(121.5%)
0.98
(115.7%)
Week 52 Number Analyzed 378 participants 381 participants
0.68
(129.7%)
0.90
(126.3%)
15.Secondary Outcome
Title Change in Body Weight (%)
Hide Description Relative change from baseline (week 0) in body weight (kg) was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Mean (Standard Deviation)
Unit of Measure: Percentage change
Week 26 Number Analyzed 393 participants 396 participants
-4.34  (4.51) -4.14  (4.12)
Week 52 Number Analyzed 386 participants 383 participants
-4.38  (5.76) -4.09  (4.78)
16.Secondary Outcome
Title Change in Body Mass Index
Hide Description Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Mean (Standard Deviation)
Unit of Measure: Kilograms per square meter (kg/m^2)
Week 26 Number Analyzed 392 participants 396 participants
-1.4  (1.6) -1.4  (1.4)
Week 52 Number Analyzed 385 participants 383 participants
-1.5  (2.0) -1.4  (1.6)
17.Secondary Outcome
Title Change in Waist Circumference
Hide Description Change from baseline (week 0) in waist circumference was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Mean (Standard Deviation)
Unit of Measure: Centimetre (cm)
Week 26 Number Analyzed 393 participants 393 participants
-3.9  (5.1) -2.9  (5.0)
Week 52 Number Analyzed 386 participants 378 participants
-3.7  (5.5) -2.9  (5.8)
18.Secondary Outcome
Title Change in Fasting Total Cholesterol (Ratio to Baseline)
Hide Description Change from baseline (week 0) in fasting total cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of total cholesterol
Week 26 Number Analyzed 387 participants 393 participants
0.96
(18.1%)
1.02
(15.2%)
Week 52 Number Analyzed 377 participants 381 participants
0.97
(18.1%)
1.01
(17.1%)
19.Secondary Outcome
Title Change in Fasting LDL Cholesterol (Ratio to Baseline)
Hide Description Change from baseline (week 0) in fasting low density lipoprotein (LDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of LDL cholesterol
Week 26 Number Analyzed 386 participants 393 participants
0.96
(38.3%)
1.03
(24.6%)
Week 52 Number Analyzed 377 participants 381 participants
0.97
(30.1%)
1.03
(27.2%)
20.Secondary Outcome
Title Change in Fasting HDL Cholesterol (Ratio to Baseline)
Hide Description Change from baseline (week 0) in fasting high density lipoprotein (HDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of HDL cholesterol
Week 26 Number Analyzed 387 participants 393 participants
1.01
(13.0%)
1.07
(15.9%)
Week 52 Number Analyzed 377 participants 381 participants
1.01
(13.9%)
1.06
(14.0%)
21.Secondary Outcome
Title Change in Fasting VLDL Cholesterol (Ratio to Baseline)
Hide Description Change from baseline (week 0) in fasting very low density lipoprotein (VLDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of VLDL cholesterol
Week 26 Number Analyzed 387 participants 393 participants
0.89
(39.0%)
0.91
(34.7%)
Week 52 Number Analyzed 377 participants 381 participants
0.89
(39.3%)
0.90
(37.6%)
22.Secondary Outcome
Title Change in Fasting Free Fatty Acids (Ratio to Baseline)
Hide Description Change from baseline (week 0) in fasting free fatty acids (FFA) (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. Because of an issue with the handling of the blood samples for FFA, all FFA data are considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the FFA data. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of FFA
Week 26 Number Analyzed 385 participants 390 participants
0.95
(51.3%)
1.05
(46.9%)
Week 52 Number Analyzed 380 participants 376 participants
0.88
(53.0%)
0.97
(49.2%)
23.Secondary Outcome
Title Change in Fasting Triglycerides (Ratio to Baseline)
Hide Description Change from baseline (week 0) in fasting triglycerides (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of triglycerides
Week 26 Number Analyzed 387 participants 393 participants
0.88
(40.5%)
0.90
(36.1%)
Week 52 Number Analyzed 377 participants 381 participants
0.89
(42.3%)
0.90
(39.3%)
24.Secondary Outcome
Title Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) ADA Target (Yes/no)
Hide Description Participants who achieved HbA1c <7.0% (53 mmol/mol) (American Diabetes Association (ADA) target) at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Measure Type: Count of Participants
Unit of Measure: Participants
Week 26 Number Analyzed 392 participants 395 participants
Yes
262
  66.8%
158
  40.0%
No
130
  33.2%
237
  60.0%
Week 52 Number Analyzed 384 participants 382 participants
Yes
254
  66.1%
165
  43.2%
No
130
  33.9%
217
  56.8%
25.Secondary Outcome
Title Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no)
Hide Description Participants who achieved HbA1c ≤6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists (AACE) target) at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Measure Type: Count of Participants
Unit of Measure: Participants
Week 26 Number Analyzed 392 participants 395 participants
Yes
186
  47.4%
68
  17.2%
No
206
  52.6%
327
  82.8%
Week 52 Number Analyzed 384 participants 382 participants
Yes
182
  47.4%
83
  21.7%
No
202
  52.6%
299
  78.3%
26.Secondary Outcome
Title Participants Who Achieve Weight Loss ≥5% (Yes/no)
Hide Description Participants who achieved weight loss of ≥5% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Measure Type: Count of Participants
Unit of Measure: Participants
Week 26 Number Analyzed 393 participants 396 participants
Yes
162
  41.2%
143
  36.1%
No
231
  58.8%
253
  63.9%
Week 52 Number Analyzed 386 participants 383 participants
Yes
156
  40.4%
150
  39.2%
No
230
  59.6%
233
  60.8%
27.Secondary Outcome
Title Participants Who Achieve Weight Loss ≥10% (Yes/no)
Hide Description Participants who achieved weight loss of ≥10% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Measure Type: Count of Participants
Unit of Measure: Participants
Week 26 Number Analyzed 393 participants 396 participants
Yes
49
  12.5%
27
   6.8%
No
344
  87.5%
369
  93.2%
Week 52 Number Analyzed 386 participants 383 participants
Yes
58
  15.0%
30
   7.8%
No
328
  85.0%
353
  92.2%
28.Secondary Outcome
Title Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)
Hide Description Participants who achieved HbA1c <7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain at week 26 and week 52. Severe or BG-confirmed symptomatic hypoglycaemia: an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Measure Type: Count of Participants
Unit of Measure: Participants
Week 26 Number Analyzed 392 participants 395 participants
Yes
237
  60.5%
141
  35.7%
No
155
  39.5%
254
  64.3%
Week 52 Number Analyzed 384 participants 382 participants
Yes
214
  55.7%
149
  39.0%
No
170
  44.3%
233
  61.0%
29.Secondary Outcome
Title Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)
Hide Description Participants who achieved HbA1c reduction ≥1%-point and weight loss of ≥3% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 26 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Measure Type: Count of Participants
Unit of Measure: Participants
week 26 Number Analyzed 392 participants 395 participants
Yes
177
  45.2%
111
  28.1%
No
215
  54.8%
284
  71.9%
week 52 Number Analyzed 384 participants 382 participants
Yes
164
  42.7%
101
  26.4%
No
220
  57.3%
281
  73.6%
30.Secondary Outcome
Title Time to Additional Anti-diabetic Medication
Hide Description Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication: use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 26/week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Weeks 0-52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0-26
17
   4.1%
13
   3.2%
Week 0-52
52
  12.7%
56
  13.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Semaglutide 14 mg, Empagliflozin 25 mg
Comments Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.
Type of Statistical Test Superiority
Comments This hypothesis was not controlled for multiplicity.
Statistical Test of Hypothesis P-Value 0.3552
Comments Unadjusted two-sided p-value for test of no difference from 1.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.60 to 1.20
Estimation Comments Oral semaglutide 14 mg / Empagliflozin 25 mg
31.Secondary Outcome
Title Time to Rescue Medication
Hide Description Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication: use of new antidiabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period: the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time Frame Weeks 0-52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0-26
8
   1.9%
5
   1.2%
Week 0-52
31
   7.5%
44
  10.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Semaglutide 14 mg, Empagliflozin 25 mg
Comments Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.
Type of Statistical Test Superiority
Comments This hypothesis was not controlled for multiplicity.
Statistical Test of Hypothesis P-Value 0.2250
Comments Unadjusted two-sided p-value for test of no difference from 1.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.47 to 1.19
Estimation Comments Oral semaglutide 14 mg / Empagliflozin 25 mg
32.Secondary Outcome
Title Number of Treatment-emergent Adverse Events (TEAE)
Hide Description A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) with onset in the on-treatment observation period (the time period where participants are considered treated with trial product) and was assessed up to approximately 57 weeks (52-week treatment period plus the 5-week follow-up period).
Time Frame Weeks 0-57
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 410 409
Measure Type: Number
Unit of Measure: Events
1022 948
33.Secondary Outcome
Title Change in Amylase (Ratio to Baseline)
Hide Description Change from baseline (week 0) in amylase (units per liter [U/L]) at week 26 and week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 410 409
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of amylase
Week 26 Number Analyzed 352 participants 382 participants
1.15
(30.1%)
1.10
(24.8%)
Week 52 Number Analyzed 330 participants 359 participants
1.13
(31.5%)
1.11
(26.8%)
34.Secondary Outcome
Title Change in Lipase (Ratio to Baseline)
Hide Description Change from baseline (week 0) in lipase (U/L) at week 26 and week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 410 409
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of lipase
Week 26 Number Analyzed 352 participants 382 participants
1.37
(62.0%)
1.10
(50.8%)
Week 52 Number Analyzed 330 participants 359 participants
1.27
(63.6%)
1.07
(47.2%)
35.Secondary Outcome
Title Change in Pulse Rate
Hide Description Change from baseline (week 0) in pulse rate was evaluated at week 26 and week 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 410 409
Mean (Standard Deviation)
Unit of Measure: Beats/minute
Week 26 Number Analyzed 356 participants 383 participants
1  (10) -2  (9)
Week 52 Number Analyzed 336 participants 364 participants
1  (10) -2  (9)
36.Secondary Outcome
Title Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Hide Description Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 26 and week 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 410 409
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
SBP, week 26 Number Analyzed 357 participants 383 participants
-5  (15) -5  (14)
SBP, week 52 Number Analyzed 337 participants 364 participants
-5  (13) -4  (15)
DBP, week 26 Number Analyzed 357 participants 383 participants
-2  (9) -3  (9)
DBP, week 52 Number Analyzed 337 participants 364 participants
-3  (10) -3  (9)
37.Secondary Outcome
Title Change in ECG
Hide Description Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at week 26 and week 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS)) from week 0 to week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 410 409
Measure Type: Count of Participants
Unit of Measure: Participants
Normal (week 0) to normal (week 26) Number Analyzed 238 participants 242 participants
207
  87.0%
203
  83.9%
Normal (week 0) to abnormal NCS (week 26) Number Analyzed 238 participants 242 participants
30
  12.6%
37
  15.3%
Normal (week 0) to abnormal CS (week 26) Number Analyzed 238 participants 242 participants
1
   0.4%
2
   0.8%
Abnormal NCS (week 0) to normal (week 26) Number Analyzed 147 participants 151 participants
50
  34.0%
41
  27.2%
Abnormal NCS (week 0) to abnormal NCS (week 26) Number Analyzed 147 participants 151 participants
97
  66.0%
110
  72.8%
Abnormal NCS (week 0) to abnormal CS (week 26) Number Analyzed 147 participants 151 participants
0
   0.0%
0
   0.0%
Abnormal CS (week 0) to normal (week 26) Number Analyzed 4 participants 1 participants
1
  25.0%
0
   0.0%
Abnormal CS (week 0) CS to abnormal NCS (week 26) Number Analyzed 4 participants 1 participants
2
  50.0%
0
   0.0%
Abnormal CS (week 0) to abnormal CS (week 26) Number Analyzed 4 participants 1 participants
1
  25.0%
1
 100.0%
Normal (week 0) to normal (week 52) Number Analyzed 235 participants 235 participants
196
  83.4%
194
  82.6%
Normal (week 0) to abnormal NCS (week 52) Number Analyzed 235 participants 235 participants
39
  16.6%
39
  16.6%
Normal (week 0) to abnormal CS (week 52) Number Analyzed 235 participants 235 participants
0
   0.0%
2
   0.9%
Abnormal (week 0) NCS to normal (week 52) Number Analyzed 145 participants 144 participants
46
  31.7%
45
  31.3%
Abnormal (week 0) NCS to abnormal NCS (week 52) Number Analyzed 145 participants 144 participants
98
  67.6%
97
  67.4%
Abnormal (week 0) NCS to abnormal CS (week 52) Number Analyzed 145 participants 144 participants
1
   0.7%
2
   1.4%
Abnormal CS (week 0) to normal (week 52) Number Analyzed 4 participants 1 participants
1
  25.0%
0
   0.0%
Abnormal CS (week 0) to abnormal NCS (week 52) Number Analyzed 4 participants 1 participants
2
  50.0%
0
   0.0%
Abnormal CS (week 0) to abnormal CS (week 52) Number Analyzed 4 participants 1 participants
1
  25.0%
1
 100.0%
38.Secondary Outcome
Title Change in Physical Examination
Hide Description The physical examination findings (normal, abnormal NCS and abnormal CS) of the participants at week -2 and week 52 are presented for the following examinations: Cardiovascular system, Nervous system (central and peripheral); Gastrointestinal system, incl. mouth; General appearance; Head (ears, eyes, nose), throat, neck; Lymph node palpation; Musculoskeletal system; Respiratory system; Skin; Thyroid gland. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week -2, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 410 409
Measure Type: Count of Participants
Unit of Measure: Participants
Cardiovascular system (week -2) Number Analyzed 410 participants 409 participants
Normal
381
  92.9%
372
  91.0%
Abnormal NCS
24
   5.9%
34
   8.3%
Abnormal CS
5
   1.2%
3
   0.7%
Cardiovascular system (week 52) Number Analyzed 385 participants 382 participants
Normal
360
  93.5%
351
  91.9%
Abnormal NCS
21
   5.5%
29
   7.6%
Abnormal CS
4
   1.0%
2
   0.5%
Nervous system (week -2) Number Analyzed 410 participants 409 participants
Normal
390
  95.1%
376
  91.9%
Abnormal NCS
20
   4.9%
30
   7.3%
Abnormal CS
0
   0.0%
3
   0.7%
Nervous system (week 52) Number Analyzed 385 participants 383 participants
Normal
371
  96.4%
365
  95.3%
Abnormal NCS
13
   3.4%
17
   4.4%
Abnormal CS
1
   0.3%
1
   0.3%
Gastrointestinal system (week -2) Number Analyzed 410 participants 409 participants
Normal
387
  94.4%
384
  93.9%
Abnormal NCS
23
   5.6%
24
   5.9%
Abnormal CS
0
   0.0%
1
   0.2%
Gastrointestinal system (week 52) Number Analyzed 385 participants 382 participants
Normal
366
  95.1%
360
  94.2%
Abnormal NCS
18
   4.7%
22
   5.8%
Abnormal CS
1
   0.3%
0
   0.0%
General appearance (week -2) Number Analyzed 410 participants 409 participants
Normal
354
  86.3%
354
  86.6%
Abnormal NCS
47
  11.5%
49
  12.0%
Abnormal CS
9
   2.2%
6
   1.5%
General appearance (week 52) Number Analyzed 385 participants 383 participants
Normal
345
  89.6%
338
  88.3%
Abnormal NCS
36
   9.4%
41
  10.7%
Abnormal CS
4
   1.0%
4
   1.0%
Head, throat, neck (week -2) Number Analyzed 410 participants 409 participants
Normal
389
  94.9%
382
  93.4%
Abnormal NCS
18
   4.4%
26
   6.4%
Abnormal CS
3
   0.7%
1
   0.2%
Head, throat, neck (week 52) Number Analyzed 385 participants 383 participants
Normal
376
  97.7%
362
  94.5%
Abnormal NCS
8
   2.1%
19
   5.0%
Abnormal CS
1
   0.3%
2
   0.5%
Lymph node palpation (week -2) Number Analyzed 410 participants 409 participants
Normal
409
  99.8%
409
 100.0%
Abnormal NCS
1
   0.2%
0
   0.0%
Abnormal CS
0
   0.0%
0
   0.0%
Lymph node palpation (week 52) Number Analyzed 385 participants 381 participants
Normal
385
 100.0%
381
 100.0%
Abnormal NCS
0
   0.0%
0
   0.0%
Abnormal CS
0
   0.0%
0
   0.0%
Musculoskeletal system (week -2) Number Analyzed 410 participants 409 participants
Normal
389
  94.9%
384
  93.9%
Abnormal NCS
18
   4.4%
25
   6.1%
Abnormal CS
3
   0.7%
0
   0.0%
Musculoskeletal system (week 52) Number Analyzed 385 participants 383 participants
Normal
370
  96.1%
363
  94.8%
Abnormal NCS
15
   3.9%
20
   5.2%
Abnormal CS
0
   0.0%
0
   0.0%
Respiratory system (week -2) Number Analyzed 410 participants 409 participants
Normal
400
  97.6%
403
  98.5%
Abnormal NCS
9
   2.2%
6
   1.5%
Abnormal CS
1
   0.2%
0
   0.0%
Respiratory system (week 52) Number Analyzed 385 participants 382 participants
Normal
375
  97.4%
378
  99.0%
Abnormal NCS
8
   2.1%
4
   1.0%
Abnormal CS
2
   0.5%
0
   0.0%
Skin (week -2) Number Analyzed 410 participants 409 participants
Normal
357
  87.1%
354
  86.6%
Abnormal NCS
50
  12.2%
53
  13.0%
Abnormal CS
3
   0.7%
2
   0.5%
Skin (week 52) Number Analyzed 385 participants 383 participants
Normal
346
  89.9%
340
  88.8%
Abnormal NCS
37
   9.6%
42
  11.0%
Abnormal CS
2
   0.5%
1
   0.3%
Thyroid gland (week -2) Number Analyzed 410 participants 409 participants
Normal
399
  97.3%
389
  95.1%
Abnormal NCS
11
   2.7%
18
   4.4%
Abnormal CS
0
   0.0%
2
   0.5%
Thyroid gland (week 52) Number Analyzed 385 participants 383 participants
Normal
376
  97.7%
367
  95.8%
Abnormal NCS
9
   2.3%
16
   4.2%
Abnormal CS
0
   0.0%
0
   0.0%
39.Secondary Outcome
Title Change in Eye Examination
Hide Description The eye examination findings (normal, abnormal NCS and abnormal CS) of the participants at baseline (week -2) and week 52 are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Week -2, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 410 409
Measure Type: Count of Participants
Unit of Measure: Participants
Left eye (week -2) Number Analyzed 409 participants 407 participants
Normal
295
  72.1%
295
  72.5%
Abnormal NCS
107
  26.2%
102
  25.1%
Abnormal CS
7
   1.7%
10
   2.5%
Left eye (week 52) Number Analyzed 375 participants 372 participants
Normal
264
  70.4%
269
  72.3%
Abnormal NCS
103
  27.5%
93
  25.0%
Abnormal CS
8
   2.1%
10
   2.7%
Right eye (week -2) Number Analyzed 409 participants 409 participants
Normal
294
  71.9%
293
  71.6%
Abnormal NCS
109
  26.7%
107
  26.2%
Abnormal CS
6
   1.5%
9
   2.2%
Right eye (week 52) Number Analyzed 374 participants 373 participants
Normal
267
  71.4%
269
  72.1%
Abnormal NCS
96
  25.7%
93
  24.9%
Abnormal CS
11
   2.9%
11
   2.9%
40.Secondary Outcome
Title Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)
Hide Description This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Weeks 0-57
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Overall Number of Participants Analyzed 403
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.5%
41.Secondary Outcome
Title Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)
Hide Description This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Weeks 0-57
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Overall Number of Participants Analyzed 403
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
42.Secondary Outcome
Title Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Hide Description This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Weeks 0-57
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Overall Number of Participants Analyzed 403
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
43.Secondary Outcome
Title Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Hide Description This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Weeks 0-57
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Overall Number of Participants Analyzed 403
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
44.Secondary Outcome
Title Anti-semaglutide Binding Antibody Levels
Hide Description This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (week 0 to week 57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time Frame Weeks 0-57
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies.
Arm/Group Title Oral Semaglutide 14 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: %B/T
Week 4 Number Analyzed 1 participants
2.75  (0.00)
Week 8 Number Analyzed 1 participants
2.17  (0.00)
Week 14 Number Analyzed 0 participants
Week 26 Number Analyzed 0 participants
Week 38 Number Analyzed 0 participants
Week 52 Number Analyzed 0 participants
Week 57 Number Analyzed 0 participants
45.Secondary Outcome
Title Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
Hide Description Treatment-emergent hypoglycaemia is an episode with onset in the on-treatment observation period (the time period where participants are considered treated with trial product) and was assessed up to approximately 57 weeks (52-week treatment period plus the 5-week follow-up period). Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time Frame Weeks 0-57
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 410 409
Measure Type: Number
Unit of Measure: Episodes
10 9
46.Secondary Outcome
Title Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)
Hide Description Number of participants with treatment-emergent severe or BG-confirmed symptomatic hypoglycaemic episodes was recorded during week 0-57. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time Frame Weeks 0-57
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 410 409
Measure Type: Count of Participants
Unit of Measure: Participants
7
   1.7%
8
   2.0%
47.Secondary Outcome
Title Semaglutide Plasma Concentrations for Population PK Analyses
Hide Description Semaglutide plasma concentrations were measured after 25 minutes post-dose at week 4, 26 and 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time Frame Weeks 0-52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Overall Number of Participants Analyzed 411
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanomoles per liter (nmol/L)
Week 4 Number Analyzed 392 participants
3.5
(84.5%)
Week 26 Number Analyzed 348 participants
15.6
(112.4%)
Week 52 Number Analyzed 331 participants
14.4
(136.6%)
48.Secondary Outcome
Title SNAC Plasma Concentrations
Hide Description This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Sodium N-[8-(2-hydroxybenzoyl) amino]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at week 4, 26 and 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time Frame Weeks 0-52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Overall Number of Participants Analyzed 411
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter (ng/mL)
Week 4: 25 minutes post-dose Number Analyzed 390 participants
559
(224.6%)
Week 4: 40 minutes post-dose Number Analyzed 392 participants
375
(210.4%)
Week 26: 25 minutes post-dose Number Analyzed 350 participants
474
(272.7%)
Week 26: 40 minutes post-dose Number Analyzed 349 participants
373
(200.6%)
Week 52: 25 minutes post-dose Number Analyzed 331 participants
448
(377.5%)
Week 52: 40 minutes post-dose Number Analyzed 331 participants
301
(290.2%)
49.Secondary Outcome
Title Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Hide Description SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 26: Physical Functioning Number Analyzed 392 participants 396 participants
0.87  (7.35) 0.99  (7.11)
Week 52: Physical Functioning Number Analyzed 386 participants 383 participants
0.57  (6.79) 0.84  (7.32)
Week 26: Role functioning Number Analyzed 392 participants 396 participants
0.07  (6.82) 0.56  (8.36)
Week 52: Role functioning Number Analyzed 386 participants 382 participants
-0.61  (6.78) 0.52  (7.93)
Week 26: Bodily pain Number Analyzed 392 participants 396 participants
-0.32  (9.77) 1.04  (9.53)
Week 52: Bodily pain Number Analyzed 386 participants 383 participants
-0.33  (10.07) 1.20  (9.54)
Week 26: General health Number Analyzed 392 participants 396 participants
2.26  (6.59) 1.36  (6.56)
Week 52: General health Number Analyzed 386 participants 383 participants
2.47  (7.35) 1.86  (7.66)
Week 26: Vitality Number Analyzed 392 participants 396 participants
0.66  (7.58) 0.49  (7.60)
Week 52: Vitality Number Analyzed 386 participants 383 participants
0.83  (7.72) 1.15  (7.48)
Week 26: Social functioning Number Analyzed 392 participants 396 participants
0.50  (7.28) -0.54  (8.15)
Week 52: Social functioning Number Analyzed 386 participants 383 participants
-0.18  (8.35) -0.54  (8.63)
Week 26: Role emotional Number Analyzed 392 participants 396 participants
0.67  (9.47) 0.53  (9.49)
Week 52: Role emotional Number Analyzed 386 participants 382 participants
0.30  (9.63) 0.42  (9.93)
Week 26: Mental health Number Analyzed 392 participants 396 participants
0.94  (8.06) -0.03  (8.70)
Week 52: Mental health Number Analyzed 386 participants 383 participants
0.29  (8.71) -0.03  (9.21)
Week 26: PCS Number Analyzed 392 participants 396 participants
0.53  (6.36) 1.21  (6.39)
Week 52: PCS Number Analyzed 386 participants 382 participants
0.44  (6.26) 1.36  (6.50)
Week 26: MCS Number Analyzed 392 participants 396 participants
0.83  (7.54) -0.23  (8.40)
Week 52: MCS Number Analyzed 386 participants 382 participants
0.35  (8.36) -0.09  (8.64)
50.Secondary Outcome
Title Change in CoEQ: Scores From the 4 Domains and the 19 Items
Hide Description Change from baseline (week 0) in Control of Eating Questionnaire (CoEQ) was evaluated at weeks 26 and 52. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period.
Time Frame Week 0, week 26, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52).
Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
Overall Number of Participants Analyzed 411 410
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 26: Craving control Number Analyzed 392 participants 396 participants
0.46  (2.60) 0.21  (2.26)
Week 52: Craving control Number Analyzed 386 participants 383 participants
0.44  (2.54) 0.18  (2.38)
Week 26: Positive Mood Number Analyzed 392 participants 396 participants
0.08  (1.52) 0.19  (1.62)
Week 52: Positive Mood Number Analyzed 386 participants 383 participants
0.15  (1.75) 0.17  (1.64)
Week 26: Craving for Savoury Number Analyzed 392 participants 395 participants
-0.68  (2.13) -0.54  (2.05)
Week 52: Craving for Savoury Number Analyzed 386 participants 383 participants
-0.66  (2.16) -0.44  (2.14)
Week 26: Craving for Sweet Number Analyzed 392 participants 395 participants
-0.25  (2.15) -0.21  (2.04)
Week 52: Craving for Sweet Number Analyzed 386 participants 383 participants
-0.21  (2.23) -0.17  (2.13)
Week 26: 1.Feeling of hunger Number Analyzed 392 participants 396 participants
-0.80  (2.69) -0.09  (2.59)
Week 52: 1.Feeling of hunger Number Analyzed 386 participants 383 participants
-0.60  (2.82) 0.07  (2.56)
Week 26: 2.Feeling of fullness Number Analyzed 392 participants 395 participants
0.40  (2.65) 0.29  (2.63)
Week 52: 2.Feeling of fullness Number Analyzed 386 participants 383 participants
0.35  (2.75) 0.06  (2.67)
Week 26: 3.Desire to eat sweet foods Number Analyzed 392 participants 396 participants
-0.35  (3.04) -0.22  (2.95)
Week 52: 3.Desire to eat sweet foods Number Analyzed 386 participants 383 participants
-0.36  (3.23) -0.18  (2.85)
Week 26: 4.Desire to eat savoury foods Number Analyzed 392 participants 396 participants
-0.82  (2.99) -0.56  (3.09)
Week 52: 4.Desire to eat savoury foods Number Analyzed 386 participants 383 participants
-0.82  (3.15) -0.57  (2.93)
Week 26: 5.Feeling of happiness Number Analyzed 392 participants 396 participants
0.00  (2.24) 0.21  (2.31)
Week 52: 5.Feeling of happiness Number Analyzed 386 participants 383 participants
0.13  (2.61) 0.21  (2.36)
Week 26: 6.Feeling of anxiousness Number Analyzed 392 participants 396 participants
-0.21  (2.92) -0.31  (3.22)
Week 52: 6.Feeling of anxiousness Number Analyzed 386 participants 383 participants
-0.19  (3.03) -0.21  (3.02)
Week 26: 7.Feeling of alertness Number Analyzed 392 participants 396 participants
0.01  (2.68) 0.02  (2.57)
Week 52: 7.Feeling of alertness Number Analyzed 385 participants 383 participants
0.07  (2.73) 0.08  (2.63)
Week 26: 8.Feeling of contentment Number Analyzed 392 participants 395 participants
0.08  (2.37) 0.22  (2.42)
Week 52: 8.Feeling of contentment Number Analyzed 386 participants 383 participants
0.23  (2.54) 0.17  (2.30)
Week 26: 9.Food cravings during 7 days Number Analyzed 392 participants 396 participants
-0.43  (3.25) -0.03  (3.03)
Week 52: 9.Food cravings during 7 days Number Analyzed 386 participants 383 participants
-0.42  (3.23) -0.17  (2.98)
Week 26: 10.Strength of food cravings Number Analyzed 392 participants 396 participants
-0.27  (3.11) -0.18  (2.97)
Week 52: 10.Strength of food cravings Number Analyzed 386 participants 383 participants
-0.32  (3.13) -0.14  (3.01)
Week 26: 11.Difficulty to resist food cravings Number Analyzed 392 participants 396 participants
-0.47  (3.41) -0.35  (3.18)
Week 52: 11.Difficulty to resist food cravings Number Analyzed 386 participants 383 participants
-0.33  (3.26) -0.30  (3.24)
Week 26: 12.Eating in response to food cravings Number Analyzed 391 participants 396 participants
-0.19  (2.94) -0.12  (2.75)
Week 52: 12.Eating in response to food cravings Number Analyzed 385 participants 383 participants
-0.17  (2.97) -0.01  (2.93)
Week 26: 13.Cravings for chocolate Number Analyzed 392 participants 395 participants
-0.10  (3.03) -0.26  (3.02)
Week 52: 13.Cravings for chocolate Number Analyzed 386 participants 383 participants
0.08  (3.13) -0.12  (3.00)
Week 26: 14.Cravings for other sweet foods Number Analyzed 392 participants 395 participants
-0.39  (2.91) -0.36  (2.94)
Week 52: 14.Cravings for other sweet foods Number Analyzed 386 participants 383 participants
-0.33  (2.90) -0.24  (3.13)
Week 26: 15.Cravings for fruit or fruit juice Number Analyzed 392 participants 395 participants
-0.15  (3.29) 0.01  (3.11)
Week 52: 15.Cravings for fruit or fruit juice Number Analyzed 386 participants 383 participants
-0.22  (3.31) -0.15  (3.14)
Week 26: 16.Cravings for dairy foods Number Analyzed 392 participants 395 participants
-0.48  (3.05) -0.43  (2.88)
Week 52: 16.Cravings for dairy foods Number Analyzed 386 participants 383 participants
-0.42  (3.11) -0.16  (2.92)
Week 26: 17.Cravings for starchy foods Number Analyzed 392 participants 395 participants
-0.81  (2.99) -0.59  (2.64)
Week 52: 17.Cravings for starchy foods Number Analyzed 386 participants 383 participants
-0.78  (3.04) -0.51  (2.99)
Week 26: 18.Cravings for savoury foods Number Analyzed 392 participants 395 participants
-0.61  (3.02) -0.56  (2.93)
Week 52: 18.Cravings for savoury foods Number Analyzed 386 participants 383 participants
-0.60  (2.92) -0.50  (3.09)
Week 26: 19.Difficulty to control eating general Number Analyzed 391 participants 395 participants
-0.90  (3.09) -0.36  (2.79)
Week 52: 19.Difficulty to control eating general Number Analyzed 385 participants 383 participants
-0.97  (3.01) -0.27  (2.82)
Time Frame Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.
Adverse Event Reporting Description Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
 
Arm/Group Title Oral Semaglutide 14 mg Empagliflozin 25 mg
Hide Arm/Group Description Participants received once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). Participants received once-daily empagliflozin tablets for 52 weeks. Participants started empagliflozin at 10 mg for 8 weeks. Participants were treated with empagliflozin 25 mg if their eGFR was greater than or equal to 60 mL/min/1.73m^2 from week 8 to week 52.
All-Cause Mortality
Oral Semaglutide 14 mg Empagliflozin 25 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/410 (0.00%)      1/409 (0.24%)    
Hide Serious Adverse Events
Oral Semaglutide 14 mg Empagliflozin 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/410 (6.59%)      37/409 (9.05%)    
Blood and lymphatic system disorders     
Hypocoagulable state  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Acute myocardial infarction  1  2/410 (0.49%)  2 1/409 (0.24%)  1
Angina pectoris  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Angina unstable  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Arrhythmia  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Atrial fibrillation  1  0/410 (0.00%)  0 3/409 (0.73%)  3
Atrioventricular block second degree  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Bundle branch block left  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Cardiac failure chronic  1  2/410 (0.49%)  2 1/409 (0.24%)  1
Coronary artery disease  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Myocardial infarction  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Ventricular tachycardia  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Ear and labyrinth disorders     
Ear haemorrhage  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Inguinal hernia  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Pancreatitis  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Pancreatitis acute  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Peptic ulcer  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Small intestinal obstruction  1  1/410 (0.24%)  1 0/409 (0.00%)  0
General disorders     
Asthenia  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Chest pain  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Gait disturbance  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Non-cardiac chest pain  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Hepatobiliary disorders     
Cholangitis acute  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Cholecystitis  1  2/410 (0.49%)  2 0/409 (0.00%)  0
Cholecystitis acute  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Cholelithiasis  1  1/410 (0.24%)  1 1/409 (0.24%)  1
Immune system disorders     
Anaphylactic reaction  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Infections and infestations     
Anal abscess  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Bronchiolitis  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Escherichia urinary tract infection  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Gastroenteritis  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Meningitis bacterial  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Perichondritis  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Pneumonia  1  2/410 (0.49%)  2 1/409 (0.24%)  1
Septic shock  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Tubo-ovarian abscess  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Urosepsis  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Wound infection  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Injury, poisoning and procedural complications     
Back injury  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Deep vein thrombosis postoperative  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Femoral neck fracture  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Pubis fracture  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Investigations     
Arteriogram coronary  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Hepatic enzyme increased  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Hypokalaemia  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Lactic acidosis  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Head deformity  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Intervertebral disc protrusion  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Osteoarthritis  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Osteochondrosis  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Clear cell renal cell carcinoma  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Invasive ductal breast carcinoma  1  1/410 (0.24%)  1 1/409 (0.24%)  1
Rectal adenocarcinoma  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Squamous cell carcinoma of lung  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Nervous system disorders     
CANVAS syndrome  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Cerebrovascular accident  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Cerebrovascular disorder  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Dysarthria  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Ischaemic stroke  1  0/410 (0.00%)  0 2/409 (0.49%)  2
Lacunar infarction  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Syncope  1  2/410 (0.49%)  2 0/409 (0.00%)  0
Transient ischaemic attack  1  0/410 (0.00%)  0 2/409 (0.49%)  2
Tremor  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/410 (0.24%)  1 1/409 (0.24%)  1
Nephrolithiasis  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Reproductive system and breast disorders     
Cervical dysplasia  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Ovarian cyst  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Uterine prolapse  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  0/410 (0.00%)  0 1/409 (0.24%)  1
Sleep apnoea syndrome  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Surgical and medical procedures     
Cholecystectomy  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Coronary arterial stent insertion  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Knee arthroplasty  1  1/410 (0.24%)  1 0/409 (0.00%)  0
Vascular disorders     
Hypertension  1  1/410 (0.24%)  1 2/409 (0.49%)  2
Peripheral vascular disorder  1  0/410 (0.00%)  0 1/409 (0.24%)  1
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Semaglutide 14 mg Empagliflozin 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   128/410 (31.22%)      44/409 (10.76%)    
Gastrointestinal disorders     
Diarrhoea  1  38/410 (9.27%)  48 13/409 (3.18%)  17
Nausea  1  81/410 (19.76%)  106 10/409 (2.44%)  12
Vomiting  1  30/410 (7.32%)  40 7/409 (1.71%)  7
Infections and infestations     
Influenza  1  8/410 (1.95%)  8 21/409 (5.13%)  23
Metabolism and nutrition disorders     
Decreased appetite  1  21/410 (5.12%)  21 2/409 (0.49%)  2
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
Phone: (+1) 866-867-7178
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02863328    
Other Study ID Numbers: NN9924-4223
2015-005209-36 ( EudraCT Number )
U1111-1176-6006 ( Other Identifier: World Health Organization (WHO) )
First Submitted: August 8, 2016
First Posted: August 11, 2016
Results First Submitted: October 15, 2019
Results First Posted: December 24, 2019
Last Update Posted: March 2, 2020