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A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.

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: NCT04153929
Recruitment Status : Completed
First Posted : November 6, 2019
Results First Posted : November 29, 2022
Last Update Posted : November 29, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: BI 456906
Drug: Placebo
Drug: Semaglutide
Enrollment 413
Recruitment Details This was a randomized, multicenter placebo and active comparator controlled, double-blind within dose groups, parallel-group, 16-week trial in patients with type 2 diabetes mellitus (T2DM). An open-label arm (semaglutide) was included as benchmark to compare response curves and support assumptions for Phase III design.
Pre-assignment Details All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Arm/Group Title Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Hide Arm/Group Description This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg). Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg). Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Period Title: Overall Study
Started [1] 60 50 50 52 50 51 50 50
Treated 59 50 50 52 50 51 49 50
Completed [2] 49 41 45 36 33 45 37 45
Not Completed 11 9 5 16 17 6 13 5
Reason Not Completed
Other than listed             2             2             0             1             0             2             2             1
Lost to Follow-up             2             1             0             1             1             0             0             0
Withdrawal by Subject             3             1             0             3             1             0             1             0
Protocol Violation             0             0             0             0             0             0             1             2
Adverse Event             3             5             5             11             15             4             8             2
Not treated             1             0             0             0             0             0             1             0
[1]
Entered/Randomized
[2]
Completed planned treatment
Arm/Group Title Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide Total
Hide Arm/Group Description This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg). Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg). Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16. Total of all reporting groups
Overall Number of Baseline Participants 59 50 50 52 50 51 49 50 411
Hide Baseline Analysis Population Description
Treated set (TS): TS included all patients who were randomized and received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 50 participants 50 participants 52 participants 50 participants 51 participants 49 participants 50 participants 411 participants
57.5  (10.5) 56.1  (10.2) 58.2  (9.6) 55.3  (10.3) 59.6  (8.5) 58.3  (8.8) 57.7  (9.4) 55.8  (10.5) 57.3  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 50 participants 50 participants 52 participants 50 participants 51 participants 49 participants 50 participants 411 participants
Female
28
  47.5%
24
  48.0%
22
  44.0%
25
  48.1%
17
  34.0%
24
  47.1%
22
  44.9%
16
  32.0%
178
  43.3%
Male
31
  52.5%
26
  52.0%
28
  56.0%
27
  51.9%
33
  66.0%
27
  52.9%
27
  55.1%
34
  68.0%
233
  56.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 50 participants 50 participants 52 participants 50 participants 51 participants 49 participants 50 participants 411 participants
Hispanic or Latino
15
  25.4%
11
  22.0%
8
  16.0%
12
  23.1%
12
  24.0%
10
  19.6%
9
  18.4%
14
  28.0%
91
  22.1%
Not Hispanic or Latino
44
  74.6%
39
  78.0%
42
  84.0%
40
  76.9%
38
  76.0%
41
  80.4%
40
  81.6%
36
  72.0%
320
  77.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 50 participants 50 participants 52 participants 50 participants 51 participants 49 participants 50 participants 411 participants
American Indian or Alaska Native
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
2
   0.5%
Asian
8
  13.6%
4
   8.0%
5
  10.0%
8
  15.4%
4
   8.0%
5
   9.8%
3
   6.1%
5
  10.0%
42
  10.2%
Native Hawaiian or Other Pacific Islander
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Black or African American
3
   5.1%
3
   6.0%
1
   2.0%
2
   3.8%
2
   4.0%
4
   7.8%
3
   6.1%
2
   4.0%
20
   4.9%
White
47
  79.7%
42
  84.0%
44
  88.0%
42
  80.8%
43
  86.0%
41
  80.4%
42
  85.7%
43
  86.0%
344
  83.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
1
   2.0%
0
   0.0%
0
   0.0%
2
   0.5%
Glycosylated hemoglobin A1c (HbA1c) measured in percentage units [%]   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 59 participants 50 participants 50 participants 52 participants 50 participants 51 participants 49 participants 50 participants 411 participants
8.15  (0.85) 8.09  (0.76) 7.89  (0.80) 8.14  (0.86) 8.18  (0.97) 8.11  (0.94) 7.97  (0.71) 8.03  (0.82) 8.07  (0.84)
[1]
Measure Description: Glycosylated hemoglobin A1c (HbA1c) measured in percentage units [%] at baseline is presented.
1.Primary Outcome
Title Absolute Change in HbA1c From Baseline to 16 Weeks
Hide Description

Absolute change in glycosylated hemoglobin A1c (HbA1c) from baseline to 16 weeks after treatment start is presented. The measurements for this outcome were performed at baseline and at Week 17.

Absolute change from baseline in HbA1c to 16 weeks after treatment start was calculated by subtracting the baseline HbA1c value from the HbA1c value at Week 17.
Time Frame At baseline and at Week 17 (16 weeks after treatment start).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): This patient set included all patients who were randomized and received at least one dose of study drug and who had analysable data for at least one efficacy endpoint. Only patients with non-missing results are reported.
Arm/Group Title Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Hide Arm/Group Description:
This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Overall Number of Participants Analyzed 49 41 46 36 33 44 36 45
Mean (Standard Deviation)
Unit of Measure: percentage (%) of HbA1c
-0.23  (0.81) -0.91  (0.71) -1.37  (0.93) -1.79  (0.92) -1.67  (0.78) -1.68  (0.90) -1.79  (0.76) -1.50  (0.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg, BI 456906 0.9 mg, BI 456906 1.8 mg, BI 456906 2.7 mg, BI 456906 1.2 Twice Weekly (2.4) mg, BI 456906 1.8 Twice Weekly (3.6) mg
Comments A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.
Type of Statistical Test Other
Comments Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MCP-Mod linear model fit
Comments Model assumption: The maximum effect is achieved at 3.6 mg dose.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg, BI 456906 0.9 mg, BI 456906 1.8 mg, BI 456906 2.7 mg, BI 456906 1.2 Twice Weekly (2.4) mg, BI 456906 1.8 Twice Weekly (3.6) mg
Comments A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.
Type of Statistical Test Other
Comments Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MCP-Mod Exponential model fit
Comments Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg, BI 456906 0.9 mg, BI 456906 1.8 mg, BI 456906 2.7 mg, BI 456906 1.2 Twice Weekly (2.4) mg, BI 456906 1.8 Twice Weekly (3.6) mg
Comments A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.
Type of Statistical Test Other
Comments Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MCP-Mod Emax 1 model fit
Comments Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg, BI 456906 0.9 mg, BI 456906 1.8 mg, BI 456906 2.7 mg, BI 456906 1.2 Twice Weekly (2.4) mg, BI 456906 1.8 Twice Weekly (3.6) mg
Comments A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.
Type of Statistical Test Other
Comments Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MCP-Mod Emax 2 model fit
Comments Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg, BI 456906 0.9 mg, BI 456906 1.8 mg, BI 456906 2.7 mg, BI 456906 1.2 Twice Weekly (2.4) mg, BI 456906 1.8 Twice Weekly (3.6) mg
Comments A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.
Type of Statistical Test Other
Comments Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MCP-Mod Sigmoid Emax model fit
Comments Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.06 to -0.46
Estimation Comments Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.9 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -1.31
Confidence Interval (2-Sided) 95%
-1.60 to -1.01
Estimation Comments Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -1.56
Confidence Interval (2-Sided) 95%
-1.87 to -1.26
Estimation Comments Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 2.7 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -1.41
Confidence Interval (2-Sided) 95%
-1.72 to -1.10
Estimation Comments Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.2 Twice Weekly (2.4) mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -1.49
Confidence Interval (2-Sided) 95%
-1.78 to -1.19
Estimation Comments Difference was calculated as "BI 456906 1.2 twice weekly (2.4) mg" - "Placebo" at Week 17.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 Twice Weekly (3.6) mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -1.53
Confidence Interval (2-Sided) 95%
-1.84 to -1.22
Estimation Comments Difference was calculated as "BI 456906 1.8 twice weekly (3.6) mg" - "Placebo" at Week 17.
2.Secondary Outcome
Title Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks
Hide Description

The relative change in body weight from baseline to 16 weeks after treatment start is presented. The measurements for this outcome were performed at baseline and at Week 17.

The relative change in body weight from baseline to 16 weeks after treatment start was calculated as (body weight at Week 17 - body weight at baseline/body weight at baseline) * 100.
Time Frame At baseline and at Week 17 (16 weeks after treatment start ).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): This patient set included all patients who were randomized and received at least one dose of study drug and who had analysable data for at least one efficacy endpoint. Only patients with non-missing results are reported.
Arm/Group Title Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Hide Arm/Group Description:
This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Overall Number of Participants Analyzed 49 41 46 36 33 44 37 45
Mean (Standard Deviation)
Unit of Measure: percentage of body weight change
-1.20  (3.52) -1.86  (2.91) -4.43  (3.92) -6.63  (5.13) -6.68  (4.05) -7.16  (6.06) -8.95  (5.33) -5.40  (4.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg, BI 456906 0.9 mg, BI 456906 1.8 mg, BI 456906 2.7 mg, BI 456906 1.2 Twice Weekly (2.4) mg, BI 456906 1.8 Twice Weekly (3.6) mg
Comments A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.
Type of Statistical Test Other
Comments

Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.

MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MCP-Mod linear model fit
Comments Model assumption: The maximum effect is achieved at 3.6 mg dose.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg, BI 456906 0.9 mg, BI 456906 1.8 mg, BI 456906 2.7 mg, BI 456906 1.2 Twice Weekly (2.4) mg, BI 456906 1.8 Twice Weekly (3.6) mg
Comments A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.
Type of Statistical Test Other
Comments

Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.

MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MCP-Mod exponential model fit
Comments Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg, BI 456906 0.9 mg, BI 456906 1.8 mg, BI 456906 2.7 mg, BI 456906 1.2 Twice Weekly (2.4) mg, BI 456906 1.8 Twice Weekly (3.6) mg
Comments A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.
Type of Statistical Test Other
Comments

Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.

MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MCP-Mod Emax 1 model fit
Comments Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg, BI 456906 0.9 mg, BI 456906 1.8 mg, BI 456906 2.7 mg, BI 456906 1.2 Twice Weekly (2.4) mg, BI 456906 1.8 Twice Weekly (3.6) mg
Comments A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.
Type of Statistical Test Other
Comments

Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.

MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MCP-Mod Emax 2 model fit
Comments Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg, BI 456906 0.9 mg, BI 456906 1.8 mg, BI 456906 2.7 mg, BI 456906 1.2 Twice Weekly (2.4) mg, BI 456906 1.8 Twice Weekly (3.6) mg
Comments A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.
Type of Statistical Test Other
Comments

Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.

MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MCP-Mod Sigmoid Emax model fit
Comments Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value 0.2228
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -1.11
Confidence Interval (2-Sided) 95%
-2.90 to 0.68
Estimation Comments Difference was calculated as "BI 456906 0.3 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.9 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -3.79
Confidence Interval (2-Sided) 95%
-5.56 to -2.01
Estimation Comments Difference was calculated as "BI 456906 0.9 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -5.61
Confidence Interval (2-Sided) 95%
-7.41 to -3.81
Estimation Comments Difference was calculated as "BI 456906 1.8 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 2.7 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -6.25
Confidence Interval (2-Sided) 95%
-8.12 to -4.38
Estimation Comments Difference was calculated as "BI 456906 2.7 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.2 Twice Weekly (2.4) mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -6.25
Confidence Interval (2-Sided) 95%
-8.02 to -4.47
Estimation Comments Difference was calculated as "BI 456906 1.2 twice weekly (2.4) mg" - "Placebo" at Week 17.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 Twice Weekly (3.6) mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -7.68
Confidence Interval (2-Sided) 95%
-9.52 to -5.83
Estimation Comments Difference was calculated as "BI 456906 1.8 twice weekly (3.6) mg" - "Placebo" at Week 17.
3.Secondary Outcome
Title The Absolute Change in Body Weight From Baseline to 16 Weeks
Hide Description

The absolute change in body weight from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17.

The absolute change in body weight from baseline to 16 weeks after treatment start was calculated as: body weight at Week 17- body weight at baseline.
Time Frame At baseline and at Week 17 (16 weeks after treatment start).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): This patient set included all patients who were randomized and received at least one dose of study drug and who had analysable data for at least one efficacy endpoint. Only patients with non-missing results are reported.
Arm/Group Title Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Hide Arm/Group Description:
This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Overall Number of Participants Analyzed 49 41 46 36 33 44 37 45
Mean (Standard Deviation)
Unit of Measure: kilogram (kg)
-1.28  (3.05) -1.90  (3.12) -4.41  (4.07) -6.31  (4.53) -6.88  (4.41) -6.75  (6.10) -8.88  (4.93) -5.18  (4.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value 0.4439
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-2.34 to 1.03
Estimation Comments Difference was calculated as "BI 456906 0.3 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.9 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value 0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -3.28
Confidence Interval (2-Sided) 95%
-4.95 to -1.61
Estimation Comments Difference was calculated as "BI 456906 0.9 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -4.93
Confidence Interval (2-Sided) 95%
-6.62 to -3.23
Estimation Comments Difference was calculated as "BI 456906 1.8 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 2.7 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -5.76
Confidence Interval (2-Sided) 95%
-7.53 to -4.00
Estimation Comments Difference was calculated as "BI 456906 2.7 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.2 Twice Weekly (2.4) mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -5.44
Confidence Interval (2-Sided) 95%
-7.11 to -3.77
Estimation Comments Difference was calculated as "BI 456906 1.2 twice weekly (2.4) mg" - "Placebo" at Week 17.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 Twice Weekly (3.6) mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -7.05
Confidence Interval (2-Sided) 95%
-8.79 to -5.31
Estimation Comments Difference was calculated as "BI 456906 1.8 twice weekly (3.6) mg" - "Placebo" at Week 17.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Semaglutide
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is considered nominal.
Method Mixed Model Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -3.85
Confidence Interval (2-Sided) 95%
-5.52 to -2.18
Estimation Comments Difference was calculated as "Semaglutide" - "Placebo" at Week 17.
4.Secondary Outcome
Title The Absolute Change in Waist Circumference From Baseline to 16 Weeks
Hide Description

The absolute change in waist circumference from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17.

The absolute change in waist circumference from baseline to 16 weeks after treatment start was calculated as: waist circumference at Week 17- waist circumference at baseline.
Time Frame At baseline and at Week 17 (16 weeks after treatment start).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): This patient set included all patients who were randomized and received at least one dose of study drug and who had analysable data for at least one efficacy endpoint. Only patients with non-missing results are reported.
Arm/Group Title Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Hide Arm/Group Description:
This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Overall Number of Participants Analyzed 49 43 47 39 35 45 36 46
Mean (Standard Deviation)
Unit of Measure: centimeter
-1.95  (9.08) -2.73  (10.49) -1.80  (10.55) -3.63  (10.94) -7.47  (12.24) -4.61  (9.73) -12.89  (25.50) -3.63  (5.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value 0.7708
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-4.82 to 3.57
Estimation Comments Difference was calculated as "BI 456906 0.3 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.9 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value 0.7462
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
-3.44 to 4.79
Estimation Comments Difference was calculated as "BI 456906 0.9 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value 0.1302
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -3.32
Confidence Interval (2-Sided) 95%
-7.62 to 0.98
Estimation Comments Difference was calculated as "BI 456906 1.8 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 2.7 mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value 0.0414
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -4.61
Confidence Interval (2-Sided) 95%
-9.03 to -0.18
Estimation Comments Difference was calculated as "BI 456906 2.7 mg" - "Placebo" at Week 17.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.2 Twice Weekly (2.4) mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value 0.2273
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -2.55
Confidence Interval (2-Sided) 95%
-6.71 to 1.60
Estimation Comments Difference was calculated as "BI 456906 1.2 twice weekly (2.4) mg" - "Placebo" at Week 17.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 Twice Weekly (3.6) mg
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value 0.0002
Comments P-value is considered nominal.
Method Mixed Model for Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -8.40
Confidence Interval (2-Sided) 95%
-12.81 to -3.98
Estimation Comments Difference was calculated as "BI 456906 1.8 twice weekly (3.6) mg" - "Placebo" at Week 17.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Semaglutide
Comments Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.
Type of Statistical Test Other
Comments No formal hypotheses were tested.
Statistical Test of Hypothesis P-Value 0.1967
Comments P-value is considered nominal.
Method Mixed Model Repeated Measures (MMRM)
Comments Kenward-Roger was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Difference of adjusted means
Estimated Value -2.72
Confidence Interval (2-Sided) 95%
-6.86 to 1.42
Estimation Comments Difference was calculated as "Semaglutide" - "Placebo" at Week 17.
5.Secondary Outcome
Title Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks
Hide Description

The percentage of patients with 5 percent (%) or greater body weight loss from baseline to 16 weeks after treatment start is presented.

Measurements for this outcome were performed at baseline and at Week 17.
Time Frame At baseline and at Week 17 (16 weeks after treatment start).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): This patient set included all patients who were randomized and received at least one dose of study drug and who had analysable data for at least one efficacy endpoint. Only patients with non-missing results are reported.
Arm/Group Title Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Hide Arm/Group Description:
This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Overall Number of Participants Analyzed 59 50 50 52 50 51 49 50
Measure Type: Number
Unit of Measure: percentage of patients
6.8 8.0 38.0 42.3 46.0 56.9 57.1 38.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg
Comments Method: Logistic regression model for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.28 to 5.20
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.9 mg
Comments Method: Logistic regression model for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.92
Confidence Interval (2-Sided) 95%
2.43 to 25.74
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 mg
Comments Method: Logistic regression model for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 17.68
Confidence Interval (2-Sided) 95%
5.21 to 60.03
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 2.7 mg
Comments Method: Logistic regression model for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 25.87
Confidence Interval (2-Sided) 95%
7.31 to 91.55
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.2 Twice Weekly (2.4) mg
Comments Method: Logistic regression model for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 21.75
Confidence Interval (2-Sided) 95%
6.57 to 72.04
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 Twice Weekly (3.6) mg
Comments Method: Logistic regression model for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 35.00
Confidence Interval (2-Sided) 95%
9.84 to 124.47
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Semaglutide
Comments Method: Logistic regression model for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.22
Confidence Interval (2-Sided) 95%
2.52 to 26.79
Estimation Comments Odds Ratio was calculated as Semaglutide / Placebo.
6.Secondary Outcome
Title Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks
Hide Description

The percentage of patients with 10 % or greater body weight loss from baseline to 16 weeks after treatment start is presented.

Measurements for this outcome were performed at baseline and at Week 17.
Time Frame At baseline and at Week 17 (16 weeks after treatment start).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): This patient set included all patients who were randomized and received at least one dose of study drug and who had analysable data for at least one efficacy endpoint. Only patients with non-missing results are reported.
Arm/Group Title Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Hide Arm/Group Description:
This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).
Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Overall Number of Participants Analyzed 59 50 50 52 50 51 49 50
Measure Type: Number
Unit of Measure: percentage of patients
0.0 2.0 6.0 13.5 16.0 25.5 34.7 16.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.3 mg
Comments Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.67
Confidence Interval (2-Sided) 95%
0.14 to 95.73
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 0.9 mg
Comments Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.97
Confidence Interval (2-Sided) 95%
0.39 to 163.56
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 mg
Comments Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 25.17
Confidence Interval (2-Sided) 95%
1.35 to 471.09
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 2.7 mg
Comments Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 33.01
Confidence Interval (2-Sided) 95%
1.78 to 613.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.2 Twice Weekly (2.4) mg
Comments Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 42.44
Confidence Interval (2-Sided) 95%
2.37 to 761.44
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, BI 456906 1.8 Twice Weekly (3.6) mg
Comments Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 84.53
Confidence Interval (2-Sided) 95%
4.71 to 999
Estimation Comments Odds Ratio was calculated as BI 456906 / Placebo. The upper limit is bigger than 999.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Semaglutide
Comments Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 22.44
Confidence Interval (2-Sided) 95%
1.22 to 413.33
Estimation Comments Odds Ratio was calculated as Semaglutide / Placebo.
Time Frame From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days.
Adverse Event Reporting Description Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
 
Arm/Group Title Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Hide Arm/Group Description This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg). Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg). Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
All-Cause Mortality
Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/50 (0.00%)   0/50 (0.00%)   0/52 (0.00%)   0/50 (0.00%)   0/51 (0.00%)   0/49 (0.00%)   0/50 (0.00%) 
Hide Serious Adverse Events
Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/59 (5.08%)   1/50 (2.00%)   4/50 (8.00%)   3/52 (5.77%)   2/50 (4.00%)   1/51 (1.96%)   0/49 (0.00%)   0/50 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain † 1  0/59 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/52 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Diarrhoea † 1  0/59 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/52 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Inguinal hernia † 1  1/59 (1.69%)  0/50 (0.00%)  0/50 (0.00%)  0/52 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Irritable bowel syndrome † 1  0/59 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/52 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Mouth ulceration † 1  0/59 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/52 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Vomiting † 1  0/59 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/52 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Hepatobiliary disorders                 
Cholecystitis † 1  1/59 (1.69%)  0/50 (0.00%)  0/50 (0.00%)  0/52 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Immune system disorders                 
Autoimmune disorder † 1  0/59 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/52 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Infections and infestations                 
Cellulitis † 1  0/59 (0.00%)  0/50 (0.00%)  2/50 (4.00%)  0/52 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Viraemia † 1  0/59 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/52 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Metabolism and nutrition disorders                 
Dehydration † 1  0/59 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/52 (1.92%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia † 1  0/59 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/52 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/49 (0.00%)  0/50 (0.00%) 
Back pain † 1  0/59 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/52 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/49 (0.00%)  0/50 (0.00%) 
Nervous system disorders                 
IIIrd nerve paralysis † 1  0/59 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/52 (1.92%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Paraparesis † 1  0/59 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/52 (1.92%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Pharyngeal ulceration † 1  0/59 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/52 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Vascular disorders                 
Hypotension † 1  1/59 (1.69%)  0/50 (0.00%)  0/50 (0.00%)  0/52 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo BI 456906 0.3 mg BI 456906 0.9 mg BI 456906 1.8 mg BI 456906 2.7 mg BI 456906 1.2 Twice Weekly (2.4) mg BI 456906 1.8 Twice Weekly (3.6) mg Semaglutide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/59 (30.51%)   27/50 (54.00%)   30/50 (60.00%)   40/52 (76.92%)   33/50 (66.00%)   33/51 (64.71%)   37/49 (75.51%)   20/50 (40.00%) 
Gastrointestinal disorders                 
Abdominal discomfort † 1  0/59 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  4/52 (7.69%)  0/50 (0.00%)  1/51 (1.96%)  2/49 (4.08%)  0/50 (0.00%) 
Abdominal distension † 1  2/59 (3.39%)  3/50 (6.00%)  1/50 (2.00%)  1/52 (1.92%)  6/50 (12.00%)  2/51 (3.92%)  4/49 (8.16%)  1/50 (2.00%) 
Abdominal pain upper † 1  1/59 (1.69%)  3/50 (6.00%)  1/50 (2.00%)  1/52 (1.92%)  1/50 (2.00%)  5/51 (9.80%)  2/49 (4.08%)  1/50 (2.00%) 
Constipation † 1  0/59 (0.00%)  3/50 (6.00%)  2/50 (4.00%)  7/52 (13.46%)  7/50 (14.00%)  8/51 (15.69%)  5/49 (10.20%)  3/50 (6.00%) 
Diarrhoea † 1  7/59 (11.86%)  12/50 (24.00%)  8/50 (16.00%)  9/52 (17.31%)  7/50 (14.00%)  8/51 (15.69%)  11/49 (22.45%)  5/50 (10.00%) 
Dyspepsia † 1  0/59 (0.00%)  4/50 (8.00%)  3/50 (6.00%)  5/52 (9.62%)  4/50 (8.00%)  4/51 (7.84%)  7/49 (14.29%)  1/50 (2.00%) 
Eructation † 1  0/59 (0.00%)  2/50 (4.00%)  2/50 (4.00%)  3/52 (5.77%)  3/50 (6.00%)  1/51 (1.96%)  1/49 (2.04%)  2/50 (4.00%) 
Flatulence † 1  1/59 (1.69%)  2/50 (4.00%)  3/50 (6.00%)  2/52 (3.85%)  1/50 (2.00%)  4/51 (7.84%)  1/49 (2.04%)  0/50 (0.00%) 
Gastrooesophageal reflux disease † 1  0/59 (0.00%)  1/50 (2.00%)  3/50 (6.00%)  4/52 (7.69%)  2/50 (4.00%)  2/51 (3.92%)  1/49 (2.04%)  2/50 (4.00%) 
Nausea † 1  5/59 (8.47%)  10/50 (20.00%)  14/50 (28.00%)  25/52 (48.08%)  23/50 (46.00%)  14/51 (27.45%)  23/49 (46.94%)  6/50 (12.00%) 
Vomiting † 1  3/59 (5.08%)  7/50 (14.00%)  9/50 (18.00%)  12/52 (23.08%)  13/50 (26.00%)  6/51 (11.76%)  11/49 (22.45%)  2/50 (4.00%) 
General disorders                 
Asthenia † 1  0/59 (0.00%)  1/50 (2.00%)  2/50 (4.00%)  3/52 (5.77%)  1/50 (2.00%)  1/51 (1.96%)  2/49 (4.08%)  0/50 (0.00%) 
Fatigue † 1  0/59 (0.00%)  3/50 (6.00%)  1/50 (2.00%)  3/52 (5.77%)  2/50 (4.00%)  4/51 (7.84%)  5/49 (10.20%)  1/50 (2.00%) 
Infections and infestations                 
Nasopharyngitis † 1  3/59 (5.08%)  0/50 (0.00%)  2/50 (4.00%)  1/52 (1.92%)  1/50 (2.00%)  0/51 (0.00%)  1/49 (2.04%)  0/50 (0.00%) 
Urinary tract infection † 1  1/59 (1.69%)  0/50 (0.00%)  1/50 (2.00%)  4/52 (7.69%)  2/50 (4.00%)  1/51 (1.96%)  1/49 (2.04%)  1/50 (2.00%) 
Investigations                 
Lipase increased † 1  0/59 (0.00%)  2/50 (4.00%)  4/50 (8.00%)  1/52 (1.92%)  2/50 (4.00%)  1/51 (1.96%)  0/49 (0.00%)  3/50 (6.00%) 
Weight decreased † 1  0/59 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  2/52 (3.85%)  0/50 (0.00%)  6/51 (11.76%)  4/49 (8.16%)  1/50 (2.00%) 
Metabolism and nutrition disorders                 
Decreased appetite † 1  2/59 (3.39%)  6/50 (12.00%)  7/50 (14.00%)  6/52 (11.54%)  11/50 (22.00%)  9/51 (17.65%)  15/49 (30.61%)  3/50 (6.00%) 
Hypoglycaemia † 1  2/59 (3.39%)  1/50 (2.00%)  1/50 (2.00%)  3/52 (5.77%)  2/50 (4.00%)  0/51 (0.00%)  3/49 (6.12%)  4/50 (8.00%) 
Musculoskeletal and connective tissue disorders                 
Back pain † 1  1/59 (1.69%)  2/50 (4.00%)  0/50 (0.00%)  3/52 (5.77%)  2/50 (4.00%)  1/51 (1.96%)  0/49 (0.00%)  0/50 (0.00%) 
Nervous system disorders                 
Dizziness † 1  0/59 (0.00%)  1/50 (2.00%)  4/50 (8.00%)  0/52 (0.00%)  1/50 (2.00%)  1/51 (1.96%)  3/49 (6.12%)  1/50 (2.00%) 
Headache † 1  4/59 (6.78%)  4/50 (8.00%)  5/50 (10.00%)  4/52 (7.69%)  1/50 (2.00%)  3/51 (5.88%)  5/49 (10.20%)  0/50 (0.00%) 
1
Term from vocabulary, MedDRA 24.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04153929    
Other Study ID Numbers: 1404-0002
2019-002390-60 ( EudraCT Number )
First Submitted: November 5, 2019
First Posted: November 6, 2019
Results First Submitted: November 2, 2022
Results First Posted: November 29, 2022
Last Update Posted: November 29, 2022