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Trial record 1 of 2287 for:    SUSTAIN 1
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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 : January 23, 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Semaglutide 0.5 mg 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.
Semaglutide 1.0 mg 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.
Placebo

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.

Participant Flow:   Overall Study
    Semaglutide 0.5 mg   Semaglutide 1.0 mg   Placebo
STARTED   129   130   129 
Exposed   128   130   129 
COMPLETED   119   123   117 
NOT COMPLETED   10   7   12 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS) included all randomised subjects who had received at least 1 dose of randomised semaglutide (s.c.) or placebo.

Reporting Groups
  Description
Semaglutide 0.5 mg 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.
Semaglutide 1.0 mg 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.
Placebo

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 Total of all reporting groups

Baseline Measures
   Semaglutide 0.5 mg   Semaglutide 1.0 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 128   130   129   387 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 128   130   129   387 
   54.6  (11.1)   52.7  (11.9)   53.9  (11.0)   53.7  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 128   130   129   387 
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) 
[Units: Percentage of HbA1c]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 128   130   129   387 
   8.09  (0.89)   8.12  (0.81)   7.95  (0.85)   8.05  (0.85) 
Fasting plasma glucose [1] 
[Units: mmol/L]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 125   129   127   381 
   9.66  (2.77)   9.90  (2.50)   9.68  (2.77)   9.75  (2.67) 
[1] Number of subjects analysed=subjects with data available for fasting plasma glucose at baseline.
Body weight 
[Units: Kilogram(s)]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 128   130   129   387 
   89.81  (22.96)   96.87  (25.59)   89.05  (22.16)   91.93  (23.83) 
Diastolic blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 128   130   129   387 
   79.52  (9.06)   79.25  (8.52)   79.14  (8.39)   79.30  (8.64) 
Systolic blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 128   130   129   387 
   127.87  (13.15)   128.89  (12.92)   129.57  (13.50)   128.78  (13.18) 


  Outcome Measures

1.  Primary:   Change in HbA1c (Glycosylated Haemoglobin)   [ Time Frame: Week 0, week 30 ]

2.  Secondary:   Change in Body Weight   [ Time Frame: Week 0, week 30 ]

3.  Secondary:   Change in Fasting Plasma Glucose (FPG)   [ Time Frame: Week 0, week 30 ]

4.  Secondary:   Change in Systolic and Diastolic Blood Pressure   [ Time Frame: Week 0, week 30 ]

5.  Secondary:   Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target   [ Time Frame: At 30 weeks of treatment ]

6.  Secondary:   Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target   [ Time Frame: At 30 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


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: January 23, 2018