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Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes (SUSTAIN™1)

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ClinicalTrials.gov Identifier: NCT02054897
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : January 23, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: semaglutide
Drug: placebo
Enrollment 388
Recruitment Details Out of 87 sites, selected for recruitment, 72 sites in 8 countries randomised subjects: Canada: 7 sites; Italy: 6 sites; Japan: 5 sites; Mexico: 2 sites; Russian Federation: 8 sites; South Africa: 8 sites; United Kingdom: 4 sites; United States: 32 sites.
Pre-assignment Details  
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description Subjects were given 0.25 mg semaglutide once weekly subcutaneous (s.c.; under the skin) injections for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period. Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.

  1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
  2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
Period Title: Overall Study
Started 129 130 129
Exposed 128 130 129
Completed 119 123 117
Not Completed 10 7 12
Reason Not Completed
Withdrawal by Subject             2             0             2
Missing follow-up information             3             5             3
Lost to Follow-up             4             2             7
Randomized but not exposed             1             0             0
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo Total
Hide Arm/Group Description Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period. Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.

  1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
  2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
Total of all reporting groups
Overall Number of Baseline Participants 128 130 129 387
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide (s.c.) or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 130 participants 129 participants 387 participants
54.6  (11.1) 52.7  (11.9) 53.9  (11.0) 53.7  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 130 participants 129 participants 387 participants
Female
68
  53.1%
50
  38.5%
59
  45.7%
177
  45.7%
Male
60
  46.9%
80
  61.5%
70
  54.3%
210
  54.3%
Glycosylated haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 128 participants 130 participants 129 participants 387 participants
8.09  (0.89) 8.12  (0.81) 7.95  (0.85) 8.05  (0.85)
Fasting plasma glucose   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 125 participants 129 participants 127 participants 381 participants
9.66  (2.77) 9.90  (2.50) 9.68  (2.77) 9.75  (2.67)
[1]
Measure Analysis Population Description: Number of subjects analysed=subjects with data available for fasting plasma glucose at baseline.
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram(s)
Number Analyzed 128 participants 130 participants 129 participants 387 participants
89.81  (22.96) 96.87  (25.59) 89.05  (22.16) 91.93  (23.83)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 128 participants 130 participants 129 participants 387 participants
79.52  (9.06) 79.25  (8.52) 79.14  (8.39) 79.30  (8.64)
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 128 participants 130 participants 129 participants 387 participants
127.87  (13.15) 128.89  (12.92) 129.57  (13.50) 128.78  (13.18)
1.Primary Outcome
Title Change in HbA1c (Glycosylated Haemoglobin)
Hide Description Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time Frame Week 0, week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.

  1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
  2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
Overall Number of Participants Analyzed 128 130 129
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c
-1.47  (1.02) -1.56  (1.26) -0.00  (0.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Semaglutide 1.0 mg, Placebo
Comments For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 1.0 mg versus placebo. 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 for change in HbA1c was claimed if the upper limit of the 2-sided 95% confidence interval (CI) for the estimated difference was below 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 -1.53
Confidence Interval (2-Sided) 95%
-1.81 to -1.25
Estimation Comments Semaglutide 1.0 mg minus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Semaglutide 0.5 mg, Placebo
Comments For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 0.5 mg versus placebo, if superiority for semaglutide 1.0 mg was concluded. 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 for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 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 -1.43
Confidence Interval (2-Sided) 95%
-1.71 to -1.15
Estimation Comments Semaglutide 0.5 mg minus Placebo
2.Secondary Outcome
Title Change in Body Weight
Hide Description Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time Frame Week 0, week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.

  1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
  2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
Overall Number of Participants Analyzed 128 130 129
Mean (Standard Deviation)
Unit of Measure: kilogram(s)
-3.68  (4.03) -4.67  (5.19) -0.89  (3.46)
3.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG)
Hide Description Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time Frame Week 0, week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Number of subject analysed=subjects who contributed to the analysis.
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.

  1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
  2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
Overall Number of Participants Analyzed 125 129 127
Mean (Standard Deviation)
Unit of Measure: mmol/L
-2.41  (2.55) -2.39  (2.74) -0.55  (2.2)
4.Secondary Outcome
Title Change in Systolic and Diastolic Blood Pressure
Hide Description Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time Frame Week 0, week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.

  1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
  2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
Overall Number of Participants Analyzed 128 130 129
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic blood pressure -2.29  (12.58) -2.74  (11.58) -2.01  (11.23)
Diastolic blood pressure -0.73  (6.88) 0.22  (7.6) 0.60  (7.59)
5.Secondary Outcome
Title Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target
Hide Description Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time Frame At 30 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.

  1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
  2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
Overall Number of Participants Analyzed 128 130 129
Measure Type: Number
Unit of Measure: Percentage of subjects
Yes 74.2 72.3 24.8
No 25.8 27.7 75.2
6.Secondary Outcome
Title Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target
Hide Description Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time Frame At 30 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description:
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.

  1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
  2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
Overall Number of Participants Analyzed 128 130 129
Measure Type: Number
Unit of Measure: Percentage of subjects
Yes 59.4 60.0 13.2
No 40.6 40.0 86.8
Time Frame From the first trial product administration (in week 0) till the date of the end-of-treatment follow-up visit (in week 35 + the 7-day visit window) or on the date of the last trial product administration plus 42 days (5 weeks plus the 7 days visit window)
Adverse Event Reporting Description Safety analysis set (SAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.
 
Arm/Group Title Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Hide Arm/Group Description Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period. Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis.

  1. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period.
  2. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
All-Cause Mortality
Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/128 (5.47%)      7/130 (5.38%)      5/129 (3.88%)    
Blood and lymphatic system disorders       
Anaemia  1  0/128 (0.00%)  0 0/130 (0.00%)  0 1/129 (0.78%)  1
Cardiac disorders       
Acute myocardial infarction  1  0/128 (0.00%)  0 1/130 (0.77%)  1 0/129 (0.00%)  0
Pericarditis  1  0/128 (0.00%)  0 1/130 (0.77%)  1 0/129 (0.00%)  0
Gastrointestinal disorders       
Gastric haemorrhage  1  0/128 (0.00%)  0 0/130 (0.00%)  0 1/129 (0.78%)  2
Gastritis  1  1/128 (0.78%)  1 0/130 (0.00%)  0 0/129 (0.00%)  0
Oesophagitis  1  1/128 (0.78%)  1 0/130 (0.00%)  0 0/129 (0.00%)  0
General disorders       
Inflammation  1  0/128 (0.00%)  0 0/130 (0.00%)  0 1/129 (0.78%)  1
Hepatobiliary disorders       
Cholelithiasis  1  1/128 (0.78%)  1 0/130 (0.00%)  0 0/129 (0.00%)  0
Infections and infestations       
Cystitis  1  1/128 (0.78%)  1 0/130 (0.00%)  0 0/129 (0.00%)  0
Encephalitis  1  1/128 (0.78%)  1 0/130 (0.00%)  0 0/129 (0.00%)  0
Lobar pneumonia  1  1/128 (0.78%)  1 0/130 (0.00%)  0 0/129 (0.00%)  0
Subcutaneous abscess  1  0/128 (0.00%)  0 0/130 (0.00%)  0 1/129 (0.78%)  1
Injury, poisoning and procedural complications       
Wound  1  0/128 (0.00%)  0 1/130 (0.77%)  1 0/129 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain  1  0/128 (0.00%)  0 0/130 (0.00%)  0 1/129 (0.78%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer  1  1/128 (0.78%)  1 0/130 (0.00%)  0 0/129 (0.00%)  0
Prostate cancer  1  0/128 (0.00%)  0 1/130 (0.77%)  1 0/129 (0.00%)  0
Nervous system disorders       
Transient ischaemic attack  1  1/128 (0.78%)  1 0/130 (0.00%)  0 0/129 (0.00%)  0
Psychiatric disorders       
Mental disorder  1  1/128 (0.78%)  1 0/130 (0.00%)  0 0/129 (0.00%)  0
Renal and urinary disorders       
Calculus ureteric  1  0/128 (0.00%)  0 1/130 (0.77%)  1 0/129 (0.00%)  0
Reproductive system and breast disorders       
Postmenopausal haemorrhage  1  1/128 (0.78%)  1 0/130 (0.00%)  0 0/129 (0.00%)  0
Surgical and medical procedures       
Coronary revascularisation  1  0/128 (0.00%)  0 1/130 (0.77%)  1 0/129 (0.00%)  0
Gastric bypass  1  0/128 (0.00%)  0 2/130 (1.54%)  2 0/129 (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%
Semaglutide 0.5 mg Semaglutide 1.0 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/128 (41.41%)      47/130 (36.15%)      27/129 (20.93%)    
Gastrointestinal disorders       
Constipation  1  8/128 (6.25%)  9 5/130 (3.85%)  5 1/129 (0.78%)  2
Diarrhoea  1  16/128 (12.50%)  27 14/130 (10.77%)  19 3/129 (2.33%)  3
Dyspepsia  1  7/128 (5.47%)  13 5/130 (3.85%)  5 3/129 (2.33%)  3
Nausea  1  26/128 (20.31%)  44 31/130 (23.85%)  46 10/129 (7.75%)  12
Vomiting  1  5/128 (3.91%)  11 9/130 (6.92%)  15 2/129 (1.55%)  2
Infections and infestations       
Nasopharyngitis  1  6/128 (4.69%)  7 6/130 (4.62%)  9 7/129 (5.43%)  9
Investigations       
Lipase increased  1  8/128 (6.25%)  10 5/130 (3.85%)  5 5/129 (3.88%)  5
Nervous system disorders       
Headache  1  15/128 (11.72%)  43 9/130 (6.92%)  18 8/129 (6.20%)  13
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 up to 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: NCT02054897     History of Changes
Other Study ID Numbers: NN9535-3623
2013-000632-94 ( EudraCT Number )
U1111-1139-3090 ( Other Identifier: WHO )
JapicCTI-142442 ( Registry Identifier: JAPIC )
First Submitted: February 3, 2014
First Posted: February 4, 2014
Results First Submitted: December 22, 2017
Results First Posted: January 23, 2018
Last Update Posted: July 18, 2018