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Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes (SUSTAIN™ 5)

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ClinicalTrials.gov Identifier: NCT02305381
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : February 16, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: semaglutide
Drug: placebo
Enrollment 397
Recruitment Details The trial was conducted at 90 sites in 5 countries, as follows: Germany: 10 sites; Japan: 6 sites; Serbia: 4 sites; Slovakia: 5 sites; United States: 65.
Pre-assignment Details  
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description Subjects received semaglutide 0.25 mg subcutaneous (sc) injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial. Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30.Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial. Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Period Title: Overall Study
Started 132 132 133
Exposed 132 131 133
Premature Discontinuation of Treatment 14 [1] 16 [2] 13 [1]
Completed 127 [3] 127 [3] 126 [3]
Not Completed 5 5 7
Reason Not Completed
Unclassified             5             5             7
[1]
Subjects who prematurely discontinued treatment were allowed to continue participation in the trial.
[2]
Subjects who prematurely discontinued treatment were allowed to continue participation in the trial
[3]
Subjects who completed the trial.
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo Total
Hide Arm/Group Description Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial. Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial. Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial. Total of all reporting groups
Overall Number of Baseline Participants 132 131 133 396
Hide Baseline Analysis Population Description
Analysis was performed on full analysis set which included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants 131 participants 133 participants 396 participants
59.1  (10.3) 58.5  (9.0) 58.8  (10.9) 58.8  (10.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Adults (18-64 years) Number Analyzed 132 participants 131 participants 133 participants 396 participants
93 102 86 281
From 65-84 years Number Analyzed 132 participants 131 participants 133 participants 396 participants
39 29 46 114
85 years and over Number Analyzed 132 participants 131 participants 133 participants 396 participants
0 0 1 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 131 participants 133 participants 396 participants
Female
58
  43.9%
54
  41.2%
62
  46.6%
174
  43.9%
Male
74
  56.1%
77
  58.8%
71
  53.4%
222
  56.1%
Glycosylated haemoglobin  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated haemoglobin
Number Analyzed 132 participants 131 participants 133 participants 396 participants
8.36  (0.83) 8.31  (0.82) 8.42  (0.88) 8.37  (0.84)
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 132 participants 131 participants 133 participants 396 participants
92.74  (19.57) 92.49  (22.23) 89.88  (21.06) 91.70  (20.97)
Fasting plasma glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 132 participants 131 participants 133 participants 396 participants
161.0  (62.38) 152.5  (50.91) 154.1  (46.66) 155.9  (53.68)
Insulin dose   [1] 
Median (Full Range)
Unit of measure:  International unit
Number Analyzed 131 participants 131 participants 133 participants 395 participants
35.00
(15.00 to 300.00)
36.00
(14.00 to 320.00)
36.00
(12.00 to 124.00)
36.00
(12.00 to 320.00)
[1]
Measure Analysis Population Description: Number of participants analysed=participants with available data for insulin dose at baseline.
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 132 participants 131 participants 133 participants 396 participants
78.89  (9.72) 78.73  (9.98) 79.35  (9.71) 78.99  (9.79)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 132 participants 131 participants 133 participants 396 participants
134.87  (15.00) 134.40  (16.32) 134.99  (16.68) 134.76  (15.98)
Diabetes Treatment Satisfaction Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on scale
Number Analyzed 132 participants 131 participants 133 participants 396 participants
28.86  (6.35) 28.62  (6.45) 27.54  (6.55) 28.34  (6.46)
[1]
Measure Description: The DTSQs questionnaire was used to assess subjects’ treatment satisfaction and contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.
1.Primary Outcome
Title Change in HbA1c (Glycosylated Haemoglobin)
Hide Description Estimated mean change from baseline in HbA1c at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Overall Number of Participants Analyzed 132 131 133
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated hemoglobin
-1.45  (0.09) -1.85  (0.09) -0.09  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 1.0 mg, Placebo
Comments Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening [≤8.0% or >8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -1.75
Confidence Interval (2-Sided) 95%
-2.01 to -1.50
Estimation Comments Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semaglutide 0.5 mg, Placebo
Comments Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening [≤8.0% or >8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -1.35
Confidence Interval (2-Sided) 95%
-1.61 to -1.10
Estimation Comments Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.
2.Secondary Outcome
Title Change in Body Weight
Hide Description Estimated mean change from baseline in body weight at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set.
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Overall Number of Participants Analyzed 132 131 133
Least Squares Mean (Standard Error)
Unit of Measure: kg
-3.67  (0.36) -6.42  (0.36) -1.36  (0.37)
3.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG)
Hide Description Estimated mean change from baseline in FPG at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.
Time Frame week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set.
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Overall Number of Participants Analyzed 132 131 133
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-29.14  (3.74) -42.38  (3.76) -8.51  (4.02)
4.Secondary Outcome
Title Change in Insulin Dose
Hide Description Estimated mean change from baseline in insulin dose at week 30 was measured in terms of ratio to baseline. Responses at week 30 are analysed using an Analysis of covariance model with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.
Time Frame week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Overall Number of Participants Analyzed 132 131 133
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.90  (0.01) 0.85  (0.01) 0.96  (0.01)
5.Secondary Outcome
Title Change in Systolic and Diastolic Blood Pressure
Hide Description Estimated mean change from baseline in systolic and diastolic blood pressure at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.
Time Frame week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Overall Number of Participants Analyzed 132 131 133
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Diastolic blood pressure -1.84  (0.73) -1.50  (0.74) -2.17  (0.79)
Systolic blood pressure -4.29  (1.26) -7.27  (1.27) -0.99  (1.34)
6.Secondary Outcome
Title Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Hide Description The DTSQs questionnaire was used to assess subjects’ treatment satisfaction and contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The post-baseline responses are analysed using an ANCOVA model with treatment, country and stratification variables (HbA1c level at screening [<= 8.0% or > 8.0%] and use of metformin [yes or no]) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.
Time Frame week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Overall Number of Participants Analyzed 132 131 133
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
2.73  (0.46) 3.47  (0.46) 1.25  (0.50)
7.Secondary Outcome
Title HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target
Hide Description Percentage of subjects with HbA1C below 7.0% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.
Time Frame After 30 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Overall Number of Participants Analyzed 132 131 133
Measure Type: Number
Unit of Measure: percentage of subjects
60.6 78.6 10.5
8.Secondary Outcome
Title HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target
Hide Description Percentage of participants with HbA1c below or equal to 6.5% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.
Time Frame After 30 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set.
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Overall Number of Participants Analyzed 132 131 133
Measure Type: Number
Unit of Measure: percentage of subjects
40.9 61.1 4.5
Time Frame From the first dose of trial product until the end of the post-treatment follow-up period.The follow-up visit was scheduled to take place 5 weeks after the date of last dose of trial product with a visit window of +7 days (maximum 36 weeks).
Adverse Event Reporting Description A treatment-emergent adverse event (TEAE) was defined as an AE that had onset date (or increased in severity) during the ‘on-treatment’ observation period.
 
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial. Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial. Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
All-Cause Mortality
Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/132 (6.06%)      12/131 (9.16%)      9/133 (6.77%)    
Blood and lymphatic system disorders       
Anaemia  1  0/132 (0.00%)  0 0/131 (0.00%)  0 1/133 (0.75%)  1
Cardiac disorders       
Acute coronary syndrome  1  1/132 (0.76%)  1 0/131 (0.00%)  0 0/133 (0.00%)  0
Cardiac failure  1  0/132 (0.00%)  0 0/131 (0.00%)  0 1/133 (0.75%)  1
Coronary artery disease  1  1/132 (0.76%)  1 0/131 (0.00%)  0 0/133 (0.00%)  0
Eye disorders       
Cataract  1  0/132 (0.00%)  0 0/131 (0.00%)  0 1/133 (0.75%)  1
Gastrointestinal disorders       
Gastrooesophageal reflux disease  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
General disorders       
Pyrexia  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis acute  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Immune system disorders       
Drug hypersensitivity  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Infections and infestations       
Bronchitis  1  0/132 (0.00%)  0 0/131 (0.00%)  0 1/133 (0.75%)  1
Clostridium difficile colitis  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Diverticulitis  1  0/132 (0.00%)  0 0/131 (0.00%)  0 1/133 (0.75%)  1
Meningitis aseptic  1  0/132 (0.00%)  0 0/131 (0.00%)  0 1/133 (0.75%)  1
Pneumonia  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Pyelonephritis  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Pyelonephritis acute  1  0/132 (0.00%)  0 0/131 (0.00%)  0 1/133 (0.75%)  1
Sinusitis  1  1/132 (0.76%)  1 0/131 (0.00%)  0 0/133 (0.00%)  0
Injury, poisoning and procedural complications       
Procedural pain  1  1/132 (0.76%)  1 0/131 (0.00%)  0 0/133 (0.00%)  0
Investigations       
Blood pressure increased  1  1/132 (0.76%)  1 0/131 (0.00%)  0 0/133 (0.00%)  0
Weight decreased  1  1/132 (0.76%)  1 0/131 (0.00%)  0 0/133 (0.00%)  0
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control  1  0/132 (0.00%)  0 0/131 (0.00%)  0 1/133 (0.75%)  1
Hypoglycaemia  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Lumbar spinal stenosis  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Spondylolisthesis  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Nervous system disorders       
Carotid artery stenosis  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Hypoglycaemic unconsciousness  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Ischaemic stroke  1  1/132 (0.76%)  1 0/131 (0.00%)  0 0/133 (0.00%)  0
Psychiatric disorders       
Depression  1  0/132 (0.00%)  0 0/131 (0.00%)  0 1/133 (0.75%)  1
Schizophrenia  1  1/132 (0.76%)  1 0/131 (0.00%)  0 0/133 (0.00%)  0
Surgical and medical procedures       
Carotid endarterectomy  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Coronary arterial stent insertion  1  1/132 (0.76%)  1 0/131 (0.00%)  0 0/133 (0.00%)  0
Coronary artery bypass  1  0/132 (0.00%)  0 1/131 (0.76%)  1 1/133 (0.75%)  1
Peripheral artery angioplasty  1  1/132 (0.76%)  1 0/131 (0.00%)  0 0/133 (0.00%)  0
Peripheral artery stent insertion  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Vascular disorders       
Femoral artery occlusion  1  0/132 (0.00%)  0 0/131 (0.00%)  0 1/133 (0.75%)  1
Peripheral arterial occlusive disease  1  0/132 (0.00%)  0 1/131 (0.76%)  1 0/133 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/132 (39.39%)      54/131 (41.22%)      34/133 (25.56%)    
Gastrointestinal disorders       
Diarrhoea  1  6/132 (4.55%)  6 9/131 (6.87%)  9 2/133 (1.50%)  2
Nausea  1  15/132 (11.36%)  21 22/131 (16.79%)  23 6/133 (4.51%)  6
Vomiting  1  8/132 (6.06%)  9 15/131 (11.45%)  17 4/133 (3.01%)  4
Infections and infestations       
Nasopharyngitis  1  11/132 (8.33%)  14 6/131 (4.58%)  6 14/133 (10.53%)  16
Upper respiratory tract infection  1  8/132 (6.06%)  10 1/131 (0.76%)  1 4/133 (3.01%)  4
Urinary tract infection  1  2/132 (1.52%)  3 4/131 (3.05%)  5 8/133 (6.02%)  11
Investigations       
Lipase increased  1  12/132 (9.09%)  15 7/131 (5.34%)  7 4/133 (3.01%)  4
Metabolism and nutrition disorders       
Decreased appetite  1  5/132 (3.79%)  5 7/131 (5.34%)  7 1/133 (0.75%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
Results Point of Contact
Name/Title: Global Clinical Registry (GCR, 1452)
Organization: Novo Nordisk A/S
Publications of Results:
Rodbard H, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu P-L, Wijayasinghe N, Norwood P. Efficacy and safety of semaglutide once-weekly vs placebo as add-on to basal insulin alone or in combination with metformin in subjects with type 2 diabetes (SUSTAIN 5). Diabetologia. 2016; 59: S364-5.
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02305381     History of Changes
Other Study ID Numbers: NN9535-3627
2013-004502-26 ( EudraCT Number )
U1111-1149-3738 ( Other Identifier: WHO )
JapicCTI-142729 ( Other Identifier: JAPIC )
First Submitted: November 28, 2014
First Posted: December 2, 2014
Results First Submitted: December 14, 2017
Results First Posted: February 16, 2018
Last Update Posted: June 11, 2019