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Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes (SUSTAIN 10)

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ClinicalTrials.gov Identifier: NCT03191396
Recruitment Status : Completed
First Posted : June 19, 2017
Results First Posted : August 28, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: Semaglutide
Drug: Liraglutide
Enrollment 577
Recruitment Details

The trial was conducted at 77 sites in 11 countries as follows (number of sites that screened subjects/ number of sites that randomised subjects):

Bulgaria (9/ 9); Czech Republic (5/ 5); Finland (8/ 8); France (8/ 8); Hungary (8/ 8); Italy (4/ 4); Poland (3/ 3); Slovenia (4/ 4); Spain (5/ 5); Sweden (6/ 6); United Kingdom (17/ 17)

Pre-assignment Details After screening, subjects were required to continue their oral anti-diabetic drug (OAD) pre-trial background medication (i.e. metformin, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulphonyl ureas, or combinations of these) throughout the entire trial.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these). Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Period Title: Overall Study
Started 290 287
Completed 287 282
Not Completed 3 5
Reason Not Completed
Lost to Follow-up             0             3
Withdrawal by Subject             3             2
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg Total
Hide Arm/Group Description Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these). Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these). Total of all reporting groups
Overall Number of Baseline Participants 290 287 577
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 290 participants 287 participants 577 participants
60.1  (10.5) 58.9  (10.0) 59.5  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
Female
130
  44.8%
120
  41.8%
250
  43.3%
Male
160
  55.2%
167
  58.2%
327
  56.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
Hispanic or Latino
6
   2.1%
3
   1.0%
9
   1.6%
Not Hispanic or Latino
268
  92.4%
269
  93.7%
537
  93.1%
Unknown or Not Reported
16
   5.5%
15
   5.2%
31
   5.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 287 participants 577 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   1.7%
3
   1.0%
8
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   0.7%
1
   0.3%
3
   0.5%
White
264
  91.0%
268
  93.4%
532
  92.2%
More than one race
3
   1.0%
0
   0.0%
3
   0.5%
Unknown or Not Reported
16
   5.5%
15
   5.2%
31
   5.4%
1.Primary Outcome
Title Change in HbA1c
Hide Description Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: Percentage of glycosylated haemoglobin
-1.7  (0.9) -1.1  (1.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 1.0 mg, Liraglutide 1.2 mg
Comments The responses are analysed using an ANCOVA with treatment and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Type of Statistical Test Non-Inferiority
Comments HbA1c non-inferiority was tested using a non-inferiority margin of 0.3.
Statistical Test of Hypothesis P-Value <0.0001
Comments The non-inferiority p-value is calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-0.82 to -0.56
Estimation Comments Semaglutide 1.0 mg - Liraglutide 1.2 mg
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semaglutide 1.0 mg, Liraglutide 1.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-0.82 to -0.56
Estimation Comments Semaglutide 1.0 mg - Liraglutide 1.2 mg
2.Secondary Outcome
Title Change in Body Weight (kg)
Hide Description Mean change from baseline (week 0) to week 30 in body weight measured in kilograms. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: kg
-5.8  (4.7) -2.0  (4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 1.0 mg, Liraglutide 1.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -3.83
Confidence Interval (2-Sided) 95%
-4.57 to -3.09
Estimation Comments Semaglutide 1.0 mg - Liraglutide 1.2 mg
3.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG)
Hide Description Mean change from baseline in fasting plasma glucose measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: mmol/L
-2.65  (2.19) -1.46  (2.42)
4.Secondary Outcome
Title Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile
Hide Description Mean change from baseline in 7-point profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The mean of the 7-point SMPG profile, defined as the area under the profile, was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: mmol/L
-3.0  (2.0) -2.1  (2.3)
5.Secondary Outcome
Title Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)
Hide Description Mean post prandial glucose incrememts over all meals. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: mmol/L
-1.0  (1.8) -0.4  (1.9)
6.Secondary Outcome
Title Change in Fasting Blood Lipids: Total Cholesterol
Hide Description The change from baseline in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
0.96
(16.8%)
0.98
(16.9%)
7.Secondary Outcome
Title Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol
Hide Description The change from baseline in LDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
0.99
(28.3%)
0.99
(27.2%)
8.Secondary Outcome
Title Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol
Hide Description The change from baseline in HDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
1.01
(14.6%)
0.99
(12.9%)
9.Secondary Outcome
Title Change in Fasting Blood Lipids: Triglycerides
Hide Description The change from baseline in triglycerides is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
0.83
(41.5%)
0.91
(39.5%)
10.Secondary Outcome
Title Change in Body Mass Index (BMI)
Hide Description Mean change from baseline (week 0) to week 30 in BMI. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: kg/sqm
-2.0  (1.6) -0.7  (1.4)
11.Secondary Outcome
Title Change in Waist Circumference
Hide Description Mean change in waist circumference (cm) from baseline (week 0) to week 30. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: cm
-5.2  (5.6) -2.4  (4.6)
12.Secondary Outcome
Title Change in Systolic Blood Pressure
Hide Description Change in systolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: mmHg
-4.3  (13.4) -3.7  (13.8)
13.Secondary Outcome
Title Change in Diastolic Blood Pressure
Hide Description Change in diastolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.5  (8.6) -1.3  (8.4)
14.Secondary Outcome
Title Change in Body Weight (%)
Hide Description Mean relative change from baseline in body weight measured in percentage. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: percentage of body weight
-6.1  (4.9) -2.0  (4.2)
15.Secondary Outcome
Title Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target
Hide Description Percentage of subjects who achieved HbA1c less than 7.0% (53 mmol/mol) according to American Diabetes Association (ADA) target, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame After 30 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: percentage of participants
80.4 45.9
16.Secondary Outcome
Title Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target
Hide Description Percentage of subjects who achieved HbA1c less than 6.5% (48 mmol/mol) according to AACE target,after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame After 30 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: percentage of participants
58.5 24.8
17.Secondary Outcome
Title Subjects Who Achieve Weight Loss Above or Equal to 3%
Hide Description Percentage of subjects who achieved weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame After 30 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: percentage of participants
72.7 33.9
18.Secondary Outcome
Title Subjects Who Achieve Weight Loss Above or Equal to 5%
Hide Description Percentage of subjects who achieved weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame After 30 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: Percentage of participants
55.9 17.7
19.Secondary Outcome
Title Subjects Who Achieve Weight Loss Above or Equal to 10%
Hide Description Percentage of subjects who achieved weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame After 30 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: Percentage of participants
19.1 4.4
20.Secondary Outcome
Title Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
Hide Description Percentage of subjects who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame After 30 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: Percentage of participants
75.6 36.8
21.Secondary Outcome
Title Subjects Who Achieve HbA1c Reduction Above or Equal to 1%
Hide Description Percentage of subjects who achieved weight loss above or equal to 1% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame After 30 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: Percentage of participants
82.8 48.3
22.Secondary Outcome
Title Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%
Hide Description Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame After 30 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: Percentage of participants
62.4 20.9
23.Secondary Outcome
Title Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%
Hide Description Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame After 30 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: Percentage of participants
49.6 11.9
24.Secondary Outcome
Title Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%
Hide Description Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame After 30 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Measure Type: Number
Unit of Measure: Percentage of participants
17.1 3.6
25.Secondary Outcome
Title Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains
Hide Description Short form-36 version 2 (SF-36v2) is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL). The questionnaire measures the individual overall HRQoL on 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each domain is scored using the sum of the individual item responses and normalised relative to the 2009 US reference population. Overall, the domain scores range from around 0-100 (higher scores indicated a better HRQoL), where the range of possible scores depends on the 2009 US reference population for each domain. The two total summary scores (mental and physical summary components) are calculated through weighted sums of the 8 domain scores. The presented result is the change from baseline (week 0) to week 30 in SF-36v2 scores. A positive change in score indicates an improvement since baseline.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical functioning Number Analyzed 290 participants 287 participants
1.8  (5.8) 1.4  (6.6)
Role-physical Number Analyzed 289 participants 287 participants
1.4  (7.2) 0.6  (6.7)
Bodily pain Number Analyzed 290 participants 287 participants
2.2  (9.1) 1.5  (9.8)
General health Number Analyzed 290 participants 287 participants
2.7  (7.9) 1.6  (7.7)
Social functioning Number Analyzed 290 participants 287 participants
1.7  (8.7) 0.9  (7.7)
Role-emotional Number Analyzed 289 participants 287 participants
1.2  (8.5) 1.0  (8.0)
Vitality Number Analyzed 290 participants 287 participants
3.0  (8.0) 1.1  (8.0)
Mental health Number Analyzed 290 participants 287 participants
1.7  (8.2) 0.3  (7.2)
Mental component summary Number Analyzed 289 participants 287 participants
1.7  (7.9) 0.5  (7.5)
Physical component summary Number Analyzed 289 participants 287 participants
2.1  (6.4) 1.4  (5.9)
26.Secondary Outcome
Title Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately
Hide Description The DTSQs questionnaire was used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for diabetes in terms of convenience, flexibility and general feelings regarding treatment. Q 1 = "satisfaction with current treatment"; Q 2 = "hyperglycemia"; Q 3 = "hypoglycemia"; Q 4 = "flexibility"; Q 5 = "convenience"; Q 6 = "understanding of diabetes"; Q 7 = "recommend treatment to others"; and Q 8 = "willingness to continue". Each item is rated on a 7-point Likert scale with a score ranging from 0 (ie, very dissatisfied) to 6 (ie, very satisfied). DTSQ items 2 and 3 are rated differently: 0 reflects 'never' and 6 reflects 'most of the time'. The 'treatment satisfaction' score is the sum of 6 of the 8 DTSQs components (Q 1, 4, 5, 6, 7 and 8) (range 0-36). Higher scores on the DTSQ total score indicate higher treatment satisfaction. The results presented is the change from baseline (week 0) to week 30 in DTSQ scores.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 290 287
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Q1. Satisfaction with current treatment Number Analyzed 290 participants 286 participants
0.9  (1.7) 0.9  (1.5)
Q2. Hyperglycemia Number Analyzed 290 participants 286 participants
-2.1  (2.1) -1.6  (2.3)
Q3. Hypoglycemia Number Analyzed 290 participants 286 participants
0.1  (1.7) 0.1  (1.6)
Q4. Flexibility Number Analyzed 290 participants 286 participants
0.7  (1.5) 0.6  (1.5)
Q5. Convenience Number Analyzed 289 participants 286 participants
0.7  (1.5) 0.6  (1.5)
Q6. Understanding of diabetes Number Analyzed 290 participants 284 participants
0.6  (1.4) 0.5  (1.3)
Q7. Recommend treatment to others Number Analyzed 288 participants 286 participants
0.7  (1.5) 0.7  (1.4)
Q8. Willingness to continue Number Analyzed 290 participants 285 participants
1.0  (1.8) 0.9  (1.8)
Treatment satisfaction summary score Number Analyzed 290 participants 286 participants
4.6  (7.0) 4.2  (6.6)
27.Secondary Outcome
Title Number of Treatment-emergent Adverse Events (TEAE)
Hide Description A TEAE was defined as an adverse event with onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period represents the time period where subjects were considered exposed to trial product.
Time Frame Week 0 to week 35
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Measure Type: Number
Unit of Measure: Events
758 691
28.Secondary Outcome
Title Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Hide Description Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time Frame Week 0 to week 35
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Measure Type: Number
Unit of Measure: Episodes of hypoglycaemia
8 8
29.Secondary Outcome
Title Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes
Hide Description Number of subjects with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes is presented. Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time Frame Week 0 to week 35
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Measure Type: Number
Unit of Measure: Participants
5 7
30.Secondary Outcome
Title Change in Haematology - Haemoglobin
Hide Description Mean change from baseline (week 0) to week 30 in haemoglobin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mmol/L
1.0
(16.0%)
1.0
(0.0%)
31.Secondary Outcome
Title Change in Haematology - Haematocrit
Hide Description Mean change from baseline (week 0) to week 30 in haematology laboratory parameter haematocrit. Haematocrit is the volume of red blood cells in the total blood. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: percent change
1.5
(111.7%)
1.1
(130.9%)
32.Secondary Outcome
Title Change in Haematology - Thrombocytes and Leukocytes
Hide Description Mean change from baseline (week 0) to week 30 in haematology laboratory parameters thrombocytes and leukocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 10^9 cells/L
Thrombocytes Number Analyzed 233 participants 245 participants
18.4
(126.0%)
21.5
(138.9%)
Leukocytes Number Analyzed 289 participants 287 participants
0.14
(133.2%)
0.14
(117.3%)
33.Secondary Outcome
Title Change in Haematology - Erythrocytes
Hide Description Mean change from baseline (week 0) to week 30 in haematology laboratory parameter erythrocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 10^12 cells/L
0.14
(133.2%)
0.14
(117.3%)
34.Secondary Outcome
Title Change in Biochemistry - Calcium, Pottassium and Sodium
Hide Description Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters calcium, pottassium and sodium. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mmol/L
Calcium Number Analyzed 247 participants 260 participants
0.07
(107.0%)
0.07
(103.8%)
Pottassium Number Analyzed 246 participants 260 participants
0.3
(96.0%)
0.3
(77.3%)
Sodium Number Analyzed 247 participants 260 participants
1.8
(65.3%)
1.7
(61.4%)
35.Secondary Outcome
Title Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.
Hide Description Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mmol/L
Alkaline phosphatase Number Analyzed 247 participants 260 participants
5.5
(117.5%)
6.4
(121.0%)
Alanine Aminotransferase Number Analyzed 245 participants 259 participants
5.3
(126.1%)
5.0
(137.7%)
Aspartate Aminotransferase Number Analyzed 245 participants 257 participants
3.5
(129.9%)
3.1
(119.5%)
36.Secondary Outcome
Title Change in Biochemistry - Amylase and Lipase
Hide Description Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters amylase and lypase. Observed data with multiple imputation for missing data is presented. Missing data were imputed using observed data from subjects within the same group defined by actual treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: U/L
Amylase
10.3
(124.7%)
8.4
(138.2%)
Lipase
15.8
(154.6%)
14.0
(154.5%)
37.Secondary Outcome
Title Change in Biochemistry - Creatinine and Bilirubin
Hide Description Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters creatinine and bilirubin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: umol/L
Creatinine Number Analyzed 247 participants 260 participants
4.1
(150.2%)
3.6
(150.0%)
Bilirubin Number Analyzed 245 participants 259 participants
1.9
(167.5%)
2.0
(126.2%)
38.Secondary Outcome
Title Change in Biochemistry - Albumin
Hide Description Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter albumin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: g/dL
0.2
(56.8%)
0.2
(55.5%)
39.Secondary Outcome
Title Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).
Hide Description Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter eGFR. eGFR is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) as defined in KDIGO guidelines. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min/1.73m2
4.0
(97.7%)
4.1
(113.9%)
40.Secondary Outcome
Title Change in Calcitonin
Hide Description Mean change from baseline (week 0) to week 30 in calcitonin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time Frame Week 0, week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
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Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/L
1.3
(165.5%)
1.1
(89.7%)
41.Secondary Outcome
Title Change in Pulse Rate
Hide Description Mean change from baseline (week 0) to week 30 in pulse rate. Pulse rate is measured as number of heart beats per minute. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time Frame Week 0, week 30
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Hide Analysis Population Description
Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product.
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description:
Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
Overall Number of Participants Analyzed 289 287
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: beats/min
2.4
(10.1%)
3.9
(10.0%)
Time Frame From the date of first dose of trial product (week 0) to end of treatment (week 30) + post treatment follow-up of 42 days.
Adverse Event Reporting Description

Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product.

AEs with onset during the on-treatment observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.

 
Arm/Group Title Semaglutide 1.0 mg Liraglutide 1.2 mg
Hide Arm/Group Description Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these). Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).
All-Cause Mortality
Semaglutide 1.0 mg Liraglutide 1.2 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/289 (0.00%)      0/287 (0.00%)    
Hide Serious Adverse Events
Semaglutide 1.0 mg Liraglutide 1.2 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/289 (5.88%)      22/287 (7.67%)    
Cardiac disorders     
Bradycardia  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Cardiac failure congestive  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Coronary artery disease  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Eye disorders     
Retinal vein occlusion  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain upper  1  1/289 (0.35%)  1 1/287 (0.35%)  1
Colitis  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Diarrhoea  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Duodenal ulcer haemorrhage  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Inguinal hernia  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Nausea  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Pancreatitis acute  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Umbilical hernia  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Vomiting  1  1/289 (0.35%)  1 1/287 (0.35%)  1
General disorders     
Facial pain  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Hepatobiliary disorders     
Cholecystitis  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Cholecystitis acute  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Cholelithiasis  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Hepatic steatosis  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Infections and infestations     
Device related infection  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Localised infection  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Pneumonia  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Pyelonephritis  1  2/289 (0.69%)  2 0/287 (0.00%)  0
Rectal abscess  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Sepsis  1  1/289 (0.35%)  1 1/287 (0.35%)  1
Urinary tract infection  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Investigations     
Cardiovascular examination  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/289 (0.35%)  1 1/287 (0.35%)  1
Diabetes mellitus inadequate control  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc disorder  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Intervertebral disc protrusion  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Osteoarthritis  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Periarthritis  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign neoplasm of bladder  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Leiomyoma  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Medullary thyroid cancer  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Prostatic adenoma  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Rectal neoplasm  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Nervous system disorders     
Cognitive disorder  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Lethargy  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Psychiatric disorders     
Confusional state  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Depression  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Calculus urinary  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Haematuria  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Nephrolithiasis  1  1/289 (0.35%)  1 0/287 (0.00%)  0
Reproductive system and breast disorders     
Menopausal symptoms  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Prostatitis  1  0/289 (0.00%)  0 1/287 (0.35%)  1
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/289 (0.00%)  0 1/287 (0.35%)  1
1
Term from vocabulary, MedDRA 21
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Semaglutide 1.0 mg Liraglutide 1.2 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   139/289 (48.10%)      113/287 (39.37%)    
Gastrointestinal disorders     
Abdominal pain  1  15/289 (5.19%)  18 6/287 (2.09%)  6
Constipation  1  17/289 (5.88%)  17 10/287 (3.48%)  13
Diarrhoea  1  45/289 (15.57%)  56 35/287 (12.20%)  43
Nausea  1  62/289 (21.45%)  88 45/287 (15.68%)  54
Vomiting  1  29/289 (10.03%)  43 23/287 (8.01%)  32
Infections and infestations     
Influenza  1  9/289 (3.11%)  12 15/287 (5.23%)  16
Nasopharyngitis  1  27/289 (9.34%)  30 30/287 (10.45%)  32
Metabolism and nutrition disorders     
Decreased appetite  1  30/289 (10.38%)  31 17/287 (5.92%)  18
Nervous system disorders     
Headache  1  27/289 (9.34%)  37 19/287 (6.62%)  32
1
Term from vocabulary, MedDRA 21
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
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Name/Title: Clinical Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
Phone: (+1) 866-867-7178
EMail: clinicaltrials@novonordisk.com
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03191396    
Other Study ID Numbers: NN9535-4339
2016-004965-22 ( Registry Identifier: EudraCT )
U1111-1190-5868 ( Other Identifier: World Health Organization (WHO) )
First Submitted: June 16, 2017
First Posted: June 19, 2017
Results First Submitted: July 8, 2019
Results First Posted: August 28, 2019
Last Update Posted: October 15, 2019