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Trial record 1 of 2934 for:    SUSTAIN 3
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Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3)

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ClinicalTrials.gov Identifier: NCT01885208
Recruitment Status : Completed
First Posted : June 24, 2013
Results First Posted : March 30, 2018
Last Update Posted : July 18, 2018
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: exenatide
Enrollment 813
Recruitment Details Out of 146 sites selected for recruitment, 138 sites in 12 countries randomised subjects to the treatment viz. Argentina: 4 sites; Croatia: 5 sites; Finland: 5 sites; France: 7 sites; Germany: 7 sites; Greece: 5 sites; Italy: 6 sites; Netherlands: 8 sites; Serbia: 5 sites; Switzerland: 5 sites; United Kingdom: 6 sites and United States: 75 sites
Pre-assignment Details  
Arm/Group Title Semaglutide 1.0 mg Exenatide ER 2.0 mg
Hide Arm/Group Description Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed. Subjects on exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
Period Title: Overall Study
Started 406 407
Exposed 404 405
Premature Discontinuation of Treatment 82 [1] 85 [1]
Completed 374 369
Not Completed 32 38
Reason Not Completed
Unclassified             32             38
[1]
Subjects who prematurely discontinued treatment were allowed to continue participation in the trial.
Arm/Group Title Semaglutide 1.0 mg Exenatide ER 2.0 mg Total
Hide Arm/Group Description Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed. Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed. Total of all reporting groups
Overall Number of Baseline Participants 404 405 809
Hide Baseline Analysis Population Description
The full analysis set (FAS) included all randomised subjects who have received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 404 participants 405 participants 809 participants
56.4  (10.3) 56.7  (11.1) 56.6  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 404 participants 405 participants 809 participants
Female
185
  45.8%
177
  43.7%
362
  44.7%
Male
219
  54.2%
228
  56.3%
447
  55.3%
Glycosylated haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated haemoglobin
Number Analyzed 404 participants 405 participants 809 participants
8.36  (0.95) 8.33  (0.96) 8.35  (0.95)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (s)
Number Analyzed 404 participants 405 participants 809 participants
96.21  (22.5) 95.37  (20.46) 95.79  (21.49)
Fasting Plasma Glucose   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/ dL
Number Analyzed 383 participants 384 participants 767 participants
190.5  (48.06) 187.5  (49.41) 189.0  (48.74)
[1]
Measure Analysis Population Description: The number of subjects analysed in the semaglutide and exenatide arms was 383 and 384, respectively.
Systolic blood pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 404 participants 404 participants 808 participants
133.35  (14.87) 133.66  (14.25) 133.51  (14.55)
[1]
Measure Analysis Population Description: The number of subjects analysed in the semaglutide and exenatide arms was 404 and 404, respectively.
Diastolic blood pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 404 participants 404 participants 808 participants
80.23  (8.67) 79.57  (8.8) 79.90  (8.73)
[1]
Measure Analysis Population Description: The number of subjects analysed in the semaglutide and exenatide arms was 404 and 404, respectively.
Patient-reported outcome: Diabetes Treatment Satisfaction Questionnaire (DTSQ)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 403 participants 405 participants 808 participants
27.35  (6.55) 27.23  (6.62) 27.29  (6.58)
[1]
Measure Description: The DTSQs was used to assess a subject’s treatment satisfaction. This questionnaire contained 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value 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.
[2]
Measure Analysis Population Description: The number of subjects analysed in the semaglutide and exenatide arms was 403 and 405, respectively.
1.Primary Outcome
Title Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Hide Description Mean change in HbA1c from baseline to week 56.
Time Frame Week 0, week 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.
Arm/Group Title Semaglutide 1.0 mg Exenatide ER 2.0 mg
Hide Arm/Group Description:
Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
Overall Number of Participants Analyzed 404 405
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated haemoglobin
-1.54  (0.06) -0.92  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 1.0 mg, Exenatide ER 2.0 mg
Comments The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Type of Statistical Test Non-Inferiority
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 exenatide ER 2.0 mg 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 [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-0.8 to -0.44
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semaglutide 1.0 mg, Exenatide ER 2.0 mg
Comments The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Type of Statistical Test Superiority
Comments Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified superiority margin (0 %).
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-0.8 to -0.44
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Mean change in body weight from baseline to week 56.
Time Frame Week 0, week 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.
Arm/Group Title Semaglutide 1.0 mg Exenatide ER 2.0 mg
Hide Arm/Group Description:
Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
Overall Number of Participants Analyzed 404 405
Least Squares Mean (Standard Error)
Unit of Measure: kilograms
-5.63  (0.29) -1.85  (0.29)
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG)
Hide Description Mean change in FPG from baseline to week 56.
Time Frame Week 0, week 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.
Arm/Group Title Semaglutide 1.0 mg Exenatide ER 2.0 mg
Hide Arm/Group Description:
Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
Overall Number of Participants Analyzed 404 405
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-51.22  (2.36) -36.1  (2.45)
4.Secondary Outcome
Title Change From Baseline in Systolic and Diastolic Blood Pressure
Hide Description Mean changes in systolic and diastolic blood pressure from baseline to week 56.
Time Frame Week 0, week 56
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.
Arm/Group Title Semaglutide 1.0 mg Exenatide ER 2.0 mg
Hide Arm/Group Description:
Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
Overall Number of Participants Analyzed 404 405
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Systolic blood pressure Number Analyzed 295 participants 275 participants
-4.6  (0.68) -2.23  (0.7)
Diastolic blood pressure Number Analyzed 295 participants 275 participants
-1.0  (0.45) -0.1  (0.46)
5.Secondary Outcome
Title Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)
Hide Description The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject’s treatment satisfaction. This questionnaire contained 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.
Arm/Group Title Semaglutide 1.0 mg Exenatide ER 2.0 mg
Hide Arm/Group Description:
Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
Overall Number of Participants Analyzed 404 405
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
4.98  (0.26) 3.96  (0.27)
6.Secondary Outcome
Title Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)
Hide Description The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.
Time Frame After 56 weeks' treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.
Arm/Group Title Semaglutide 1.0 mg Exenatide ER 2.0 mg
Hide Arm/Group Description:
Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
Overall Number of Participants Analyzed 404 405
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
190
  47.0%
89
  22.0%
No
214
  53.0%
316
  78.0%
Time Frame All adverse events are treatment-emergent adverse events (TEAEs). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-56 treatment period) and no later than the date of last dose + 42 days of follow-up.
Adverse Event Reporting Description The safety analysis set (SAS) included all randomised subjects who have received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg. Subjects in the SAS contributed to the evaluation based on the treatment actually received.
 
Arm/Group Title Sema 1.0 mg Exenatide ER
Hide Arm/Group Description Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD)therapy throughout the trial, unless rescue medication was needed. Subjects randomised to exenatide extended release (ER) 2.0 mg(Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
All-Cause Mortality
Sema 1.0 mg Exenatide ER
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sema 1.0 mg Exenatide ER
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/404 (9.41%)      24/405 (5.93%)    
Cardiac disorders     
Angina pectoris  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Arteriosclerosis coronary artery  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Atrial fibrillation  1  0/404 (0.00%)  0 3/405 (0.74%)  3
Atrioventricular block complete  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Coronary artery disease  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Coronary artery insufficiency  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Coronary artery stenosis  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Gastrointestinal disorders     
Abdominal pain  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Crohn's disease  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Diverticulum  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Duodenal ulcer  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Duodenitis  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Gastric ulcer  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Gastritis  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Pancreatitis  1  3/404 (0.74%)  3 0/405 (0.00%)  0
General disorders     
Chest discomfort  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Chest pain  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Surgical failure  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Cholelithiasis  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Infections and infestations     
Cellulitis  1  1/404 (0.25%)  1 1/405 (0.25%)  1
Encephalitis  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Gastroenteritis  1  0/404 (0.00%)  0 2/405 (0.49%)  2
Pneumonia  1  1/404 (0.25%)  1 1/405 (0.25%)  1
Respiratory tract infection  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Sepsis  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Urinary tract infection  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Urosepsis  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Vestibular neuronitis  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Injury, poisoning and procedural complications     
Spinal compression fracture  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Investigations     
HIV test positive  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Liver function test abnormal  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Diabetic ketoacidosis  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Back pain  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Spinal disorder  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Spondylolisthesis  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Tendonitis  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Vertebral foraminal stenosis  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign renal neoplasm  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Breast cancer  1  1/404 (0.25%)  1 1/405 (0.25%)  1
Castleman's disease  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Endometrial adenocarcinoma  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Endometrial cancer stage I  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Follicular thyroid cancer  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Hepatocellular carcinoma  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Invasive lobular breast carcinoma  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Prostate cancer  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Nervous system disorders     
Aphasia  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Dizziness  1  1/404 (0.25%)  1 1/405 (0.25%)  1
Ischaemic stroke  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Transient ischaemic attack  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Psychiatric disorders     
Anxiety  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Renal and urinary disorders     
Glycosuria  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Hydronephrosis  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Nephrolithiasis  1  2/404 (0.50%)  2 0/405 (0.00%)  0
Renal colic  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Urethral stenosis  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Skin and subcutaneous tissue disorders     
Blister  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Skin ulcer  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Surgical and medical procedures     
Abortion induced  1  0/404 (0.00%)  0 1/405 (0.25%)  1
Cardiac ablation  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Coronary arterial stent insertion  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Coronary artery bypass  1  2/404 (0.50%)  2 0/405 (0.00%)  0
Meniscus removal  1  1/404 (0.25%)  1 0/405 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sema 1.0 mg Exenatide ER
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   194/404 (48.02%)      187/405 (46.17%)    
Gastrointestinal disorders     
Constipation  1  26/404 (6.44%)  28 21/405 (5.19%)  26
Diarrhoea  1  46/404 (11.39%)  86 34/405 (8.40%)  58
Dyspepsia  1  27/404 (6.68%)  33 19/405 (4.69%)  23
Nausea  1  90/404 (22.28%)  159 48/405 (11.85%)  70
Vomiting  1  29/404 (7.18%)  37 25/405 (6.17%)  40
General disorders     
Injection site nodule  1  0/404 (0.00%)  0 49/405 (12.10%)  55
Infections and infestations     
Nasopharyngitis  1  39/404 (9.65%)  46 38/405 (9.38%)  51
Investigations     
Lipase increased  1  41/404 (10.15%)  51 49/405 (12.10%)  64
Metabolism and nutrition disorders     
Decreased appetite  1  32/404 (7.92%)  34 21/405 (5.19%)  24
Nervous system disorders     
Headache  1  38/404 (9.41%)  81 39/405 (9.63%)  65
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18
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 less than 60 days to protect intellectual property".
Results Point of Contact
Name/Title: Clinical Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01885208     History of Changes
Other Study ID Numbers: NN9535-3624
2012-004826-92 ( EudraCT Number )
U1111-1135-8647 ( Other Identifier: WHO )
First Submitted: June 20, 2013
First Posted: June 24, 2013
Results First Submitted: December 21, 2017
Results First Posted: March 30, 2018
Last Update Posted: July 18, 2018