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Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2)

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ClinicalTrials.gov Identifier: NCT01930188
Recruitment Status : Completed
First Posted : August 28, 2013
Results First Posted : January 7, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: semaglutide
Drug: sitagliptin
Drug: placebo
Enrollment 1231
Recruitment Details The trial was conducted at 124 sites in 18 countries: Argentina: 4; Bulgaria: 10; Czech Republic: 5; Hong Kong: 1; Hungary: 4; India: 11; Japan: 14; Mexico: 5 Norway: 5; Portugal: 6; Romania: 5; Russian Federation: 17; South Africa: 7; Spain: 7: Sweden: 4; Thailand: 4; Turkey: 9; and Ukraine: 6 sites.
Pre-assignment Details  
Arm/Group Title Semaglutide 0.5 mg + Sitagliptin Placebo Semaglutide 1.0 mg + Sitagliptin Placebo Sitagliptin + Semaglutide Placebo
Hide Arm/Group Description Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily. Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily. Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Period Title: Overall Study
Started 409 409 407
Premature Discontinuation of Treatment 53 [1] 61 [1] 32 [1]
Completed 387 388 388
Not Completed 22 21 19
Reason Not Completed
unclassified             4             5             3
Missing follow-up information             2             2             3
Lost to Follow-up             5             2             2
Death             2             1             3
Withdrawal by Subject             9             11             8
[1]
Subjects prematurely discontinued treatment were allowed to continue participation in the trial.
Arm/Group Title Semaglutide 0.5 mg + Sitagliptin Placebo Semaglutide 1.0 mg + Sitagliptin Placebo Sitagliptin + Semaglutide Placebo Total
Hide Arm/Group Description Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily. Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily. Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily. Total of all reporting groups
Overall Number of Baseline Participants 409 409 407 1225
Hide Baseline Analysis Population Description
Of 1231 randomised subjects, 6 were excluded: 1 subject each in the semaglutide 0.5 mg and 1.0 mg arms and 4 subjects in the sitagliptin arm were not exposed to trial treatment. Baseline characteristics were presented for 1225 subjects (Full Analysis Set), who received at least one dose of randomised semaglutide or sitagliptin.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 409 participants 409 participants 407 participants 1225 participants
54.8  (10.2) 56.0  (9.4) 54.6  (10.4) 55.1  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 409 participants 409 participants 407 participants 1225 participants
Female
202
  49.4%
204
  49.9%
199
  48.9%
605
  49.4%
Male
207
  50.6%
205
  50.1%
208
  51.1%
620
  50.6%
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 409 participants 409 participants 407 participants 1225 participants
8.01  (0.92) 8.04  (0.93) 8.17  (0.92) 8.07  (0.93)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 409 participants 409 participants 407 participants 1225 participants
89.93  (20.39) 89.21  (20.74) 89.29  (19.67) 89.48  (20.26)
Fasting Plasma Glucose  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 409 participants 409 participants 407 participants 1225 participants
9.33  (2.38) 9.29  (2.22) 9.60  (2.16) 9.40  (2.26)
Diastolic and Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 409 participants 409 participants 407 participants 1225 participants
Diastolic Blood pressure 80.63  (9.76) 80.87  (9.08) 80.48  (8.70) 80.66  (9.19)
Systolic Blood pressure 132.73  (16.09) 132.56  (13.93) 132.66  (14.58) 132.65  (14.88)
1.Primary Outcome
Title Change in HbA1c (Glycosylated Haemoglobin) From Baseline
Hide Description Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Arm/Group Title Semaglutide 0.5 mg + Sitagliptin Placebo Semaglutide 1.0 mg + Sitagliptin Placebo Sitagliptin + Semaglutide Placebo
Hide Arm/Group Description:
Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Overall Number of Participants Analyzed 409 409 407
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated haemoglobin
-1.32  (0.05) -1.61  (0.05) -0.55  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 1.0 mg + Sitagliptin Placebo, Sitagliptin + Semaglutide Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Post-baseline responses analysed with mixed model for repeated measurements-treatment & country (fixed) & baseline (covariate) all nested within visit
Method of Estimation Estimation Parameter treatment difference
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-1.21 to -0.91
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semaglutide 0.5 mg + Sitagliptin Placebo, Sitagliptin + Semaglutide Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 0.5 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analysis done with mixed model for repeated measurements (treatment & country as fixed factors & baseline value as covariate) all nested within visit
Method of Estimation Estimation Parameter treatment difference
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.21 to -0.62
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Body Weight From Baseline
Hide Description Change in body weight from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Arm/Group Title Semaglutide 0.5 mg + Sitagliptin Placebo Semaglutide 1.0 mg + Sitagliptin Placebo Sitagliptin + Semaglutide Placebo
Hide Arm/Group Description:
Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Overall Number of Participants Analyzed 409 409 407
Least Squares Mean (Standard Error)
Unit of Measure: kilograms
-4.28  (0.25) -6.13  (0.25) -1.93  (0.26)
3.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) From Baseline
Hide Description Change in fasting plasma glucose from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit
Arm/Group Title Semaglutide 0.5 mg + Sitagliptin Placebo Semaglutide 1.0 mg + Sitagliptin Placebo Sitagliptin + Semaglutide Placebo
Hide Arm/Group Description:
Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Overall Number of Participants Analyzed 409 409 407
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-37.38  (1.79) -46.72  (1.78) -19.85  (1.88)
4.Secondary Outcome
Title Change in Systolic and Diastolic Blood Pressure From Baseline
Hide Description Change in systolic and diastolic blood pressure from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit
Arm/Group Title Semaglutide 0.5 mg + Sitagliptin Placebo Semaglutide 1.0 mg + Sitagliptin Placebo Sitagliptin + Semaglutide Placebo
Hide Arm/Group Description:
Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Overall Number of Participants Analyzed 409 409 407
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Systolic blood pressure -5.07  (0.64) -5.61  (0.63) -2.29  (0.67)
Diastolic blood pressure -2.01  (0.42) -1.91  (0.42) -1.11  (0.44)
5.Secondary Outcome
Title Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline
Hide Description Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. The DTSQs questionnaire was used to assess subjects’ treatment satisfaction. This questionnaire contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the 1225 subjects in FAS, 76 in semaglutide 0.5 mg arm, 76 in semaglutide 1.0 mg arm, and 113 in placebo arm had missing data for the endpoint. Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Arm/Group Title Semaglutide 0.5 mg + Sitagliptin Placebo Semaglutide 1.0 mg + Sitagliptin Placebo Sitagliptin + Semaglutide Placebo
Hide Arm/Group Description:
Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Overall Number of Participants Analyzed 333 333 294
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
5.28  (0.23) 5.91  (0.23) 4.45  (0.24)
6.Secondary Outcome
Title Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)
Hide Description Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.
Time Frame After 56 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin
Arm/Group Title Semaglutide 0.5 mg + Sitagliptin Placebo Semaglutide 1.0 mg + Sitagliptin Placebo Sitagliptin + Semaglutide Placebo
Hide Arm/Group Description:
Semaglutide 0.5 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Semaglutide 1.0 mg administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin placebo (0 mg) administered orally once daily.
Subjects were randomised to 2 different placebo arms (sitagliptin + semaglutide placebo 0.5 mg and sitagliptin + semaglutide placebo 1.0 mg). Both arms were pooled together for data analysis. Semaglutide placebo administered subcutaneously (s.c., under the skin) once weekly, in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Sitagliptin (100 mg) administered orally once daily.
Overall Number of Participants Analyzed 409 409 407
Measure Type: Number
Unit of Measure: Subjects
Yes 215 270 83
No 194 139 324
Time Frame Adverse events are reported for on-treatment period i.e from the date of initiation of trial product to the end of the on-treatment period (up to 56 weeks).
Adverse Event Reporting Description Safety analysis set included all subjects exposed to at least one dose of semaglutide or sitagliptin. Number of deaths causally related to treatment is the data considered to present under ‘total number of deaths resulting from adverse events’.
 
Arm/Group Title Semaglutide 1.0 mg + Sitagliptin Placebo Semaglutide 0.5 mg + Sitagliptin Placebo Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg
Hide Arm/Group Description Semaglutide 1.0 mg once-weekly + Sitagliptin placebo once-daily Semaglutide 0.5 mg once-weekly + Sitagliptin placebo once-daily Sitagliptin 100 mg once-daily + Semaglutide placebo 1.0 mg once-weekly Sitagliptin 100 mg once-daily + Semaglutide placebo 0.5 mg once-weekly
All-Cause Mortality
Semaglutide 1.0 mg + Sitagliptin Placebo Semaglutide 0.5 mg + Sitagliptin Placebo Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Semaglutide 1.0 mg + Sitagliptin Placebo Semaglutide 0.5 mg + Sitagliptin Placebo Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/409 (7.33%)      30/409 (7.33%)      13/204 (6.37%)      16/203 (7.88%)    
Blood and lymphatic system disorders         
Abdominal lymphadenopathy  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Anaemia  1  1/409 (0.24%)  1 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Lymphadenitis  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Splenic lesion  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Cardiac disorders         
Angina pectoris  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Atrial fibrillation  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Atrioventricular block second degree  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Cardiac arrest  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Cardiac failure  1  1/409 (0.24%)  1 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Cardio-respiratory arrest  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Cardiovascular disorder  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Congestive cardiomyopathy  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Coronary artery disease  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Ischaemic cardiomyopathy  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Myocardial infarction  1  1/409 (0.24%)  1 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Myocardial ischaemia  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Endocrine disorders         
Goitre  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Eye disorders         
Cataract  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain lower  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Abdominal pain upper  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Chronic gastritis  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Colitis  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Diarrhoea  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Enteritis  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Gastritis  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Gastritis erosive  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Haemorrhoids  1  0/409 (0.00%)  0 2/409 (0.49%)  2 0/204 (0.00%)  0 0/203 (0.00%)  0
Inguinal hernia  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Intestinal obstruction  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Large intestine polyp  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Mallory-Weiss syndrome  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Pancreatic disorder  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Pancreatitis  1  0/409 (0.00%)  0 2/409 (0.49%)  2 0/204 (0.00%)  0 0/203 (0.00%)  0
Pancreatitis acute  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Pancreatitis necrotising  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Papilla of Vater stenosis  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Swollen tongue  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Umbilical hernia  1  1/409 (0.24%)  1 2/409 (0.49%)  2 0/204 (0.00%)  0 1/203 (0.49%)  1
General disorders         
Death  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Fatigue  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Granuloma  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Non-cardiac chest pain  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Pyrexia  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Cholecystitis acute  1  2/409 (0.49%)  2 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Cholelithiasis  1  2/409 (0.49%)  2 1/409 (0.24%)  1 0/204 (0.00%)  0 1/203 (0.49%)  1
Drug-induced liver injury  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Infections and infestations         
Appendicitis  1  1/409 (0.24%)  1 1/409 (0.24%)  1 1/204 (0.49%)  1 0/203 (0.00%)  0
Appendicitis perforated  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Arthritis bacterial  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Epiglottitis  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Gastroenteritis viral  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Lower respiratory tract infection  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Perineal abscess  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Peritonitis  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 1/203 (0.49%)  1
Pneumonia  1  0/409 (0.00%)  0 2/409 (0.49%)  2 0/204 (0.00%)  0 0/203 (0.00%)  0
Pyelonephritis acute  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Pyelonephritis chronic  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Sinusitis  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Urosepsis  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Injury, poisoning and procedural complications         
Gas poisoning  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Hand fracture  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Post procedural haemorrhage  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Road traffic accident  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Investigations         
Haemoglobin decreased  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Troponin I increased  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Hyperglycaemia  1  0/409 (0.00%)  0 1/409 (0.24%)  1 1/204 (0.49%)  1 1/203 (0.49%)  1
Musculoskeletal and connective tissue disorders         
Back pain  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Intervertebral disc protrusion  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Ligamentitis  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Lumbar spinal stenosis  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Musculoskeletal chest pain  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Osteitis  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Benign neoplasm of eyelid  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Bladder cancer  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Metastatic neoplasm  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Neuroendocrine carcinoma metastatic  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Papillary thyroid cancer  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Thyroid adenoma  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Uterine leiomyoma  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Nervous system disorders         
Cerebrovascular accident  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Hypoglycaemic unconsciousness  1  0/409 (0.00%)  0 0/409 (0.00%)  0 1/204 (0.49%)  1 0/203 (0.00%)  0
Ischaemic stroke  1  0/409 (0.00%)  0 0/409 (0.00%)  0 2/204 (0.98%)  2 1/203 (0.49%)  1
Syncope  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Psychiatric disorders         
Depression  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Renal and urinary disorders         
Calculus bladder  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Glycosuria  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Hydronephrosis  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Ketonuria  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Nephrolithiasis  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Renal failure  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Ovarian cyst  1  0/409 (0.00%)  0 0/409 (0.00%)  0 0/204 (0.00%)  0 1/203 (0.49%)  1
Respiratory, thoracic and mediastinal disorders         
Bronchiectasis  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Dyspnoea  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Epistaxis  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Pharyngeal oedema  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Skin and subcutaneous tissue disorders         
Angioedema  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Dermatitis  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Xanthelasma  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Surgical and medical procedures         
Haemorrhoid operation  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Meniscus operation  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Vascular disorders         
Deep vein thrombosis  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Hypertensive emergency  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Hypovolaemic shock  1  0/409 (0.00%)  0 1/409 (0.24%)  1 0/204 (0.00%)  0 0/203 (0.00%)  0
Peripheral venous disease  1  1/409 (0.24%)  1 0/409 (0.00%)  0 0/204 (0.00%)  0 0/203 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Semaglutide 1.0 mg + Sitagliptin Placebo Semaglutide 0.5 mg + Sitagliptin Placebo Sitagliptin 100 mg + Semaglutide Placebo 1.0 mg Sitagliptin 100 mg + Semaglutide Placebo 0.5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   197/409 (48.17%)      208/409 (50.86%)      75/204 (36.76%)      85/203 (41.87%)    
Gastrointestinal disorders         
Constipation  1  23/409 (5.62%)  29 18/409 (4.40%)  20 5/204 (2.45%)  5 3/203 (1.48%)  4
Diarrhoea  1  53/409 (12.96%)  85 53/409 (12.96%)  91 13/204 (6.37%)  17 16/203 (7.88%)  18
Dyspepsia  1  20/409 (4.89%)  27 26/409 (6.36%)  28 4/204 (1.96%)  4 5/203 (2.46%)  7
Nausea  1  72/409 (17.60%)  140 73/409 (17.85%)  110 13/204 (6.37%)  15 17/203 (8.37%)  23
Vomiting  1  41/409 (10.02%)  119 33/409 (8.07%)  49 6/204 (2.94%)  7 5/203 (2.46%)  9
Infections and infestations         
Influenza  1  22/409 (5.38%)  25 18/409 (4.40%)  23 13/204 (6.37%)  14 14/203 (6.90%)  16
Nasopharyngitis  1  29/409 (7.09%)  33 50/409 (12.22%)  63 19/204 (9.31%)  20 23/203 (11.33%)  31
Pharyngitis  1  10/409 (2.44%)  12 7/409 (1.71%)  7 5/204 (2.45%)  5 13/203 (6.40%)  16
Investigations         
Lipase increased  1  32/409 (7.82%)  38 33/409 (8.07%)  41 13/204 (6.37%)  16 16/203 (7.88%)  17
Metabolism and nutrition disorders         
Decreased appetite  1  27/409 (6.60%)  29 26/409 (6.36%)  28 6/204 (2.94%)  6 5/203 (2.46%)  5
Nervous system disorders         
Headache  1  29/409 (7.09%)  42 26/409 (6.36%)  81 9/204 (4.41%)  19 8/203 (3.94%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigators(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Registry (GCR, 1452)
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Publications of Results:
Ahrén B, Comas LM, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). Oral Presentation 12 Jun 2016 at American Diabetes Association - 76th Annual Scientific Sessions.
Ahrén B, Masmiquel L, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). ePoster #767 presented 12 Sep 2016 at European Association for the Study of Diabetes - 52nd Annual Meeting.
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01930188     History of Changes
Other Study ID Numbers: NN9535-3626
2012-004827-19 ( EudraCT Number )
U1111-1135-8730 ( Other Identifier: WHO )
132366 ( Other Identifier: JapicCTI )
CTRI/2014/05/004626 ( Registry Identifier: Clinical Trial Registry India (CTRI) )
First Submitted: August 23, 2013
First Posted: August 28, 2013
Results First Submitted: December 14, 2017
Results First Posted: January 7, 2019
Last Update Posted: June 13, 2019