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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 : March 30, 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

  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 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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Semaglutide 1.0 mg 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.
Exenatide ER 2.0 mg 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.

Participant Flow:   Overall Study
    Semaglutide 1.0 mg   Exenatide ER 2.0 mg
STARTED   406   407 
Exposed   404   405 
Premature Discontinuation of Treatment   82 [1]   85 [1] 
COMPLETED   374   369 
NOT COMPLETED   32   38 
Unclassified                32                38 
[1] Subjects who prematurely discontinued treatment were allowed to continue participation in the trial.



  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.
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.

Reporting Groups
  Description
Semaglutide 1.0 mg 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.
Exenatide ER 2.0 mg 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 Total of all reporting groups

Baseline Measures
   Semaglutide 1.0 mg   Exenatide ER 2.0 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 404   405   809 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 404   405   809 
   56.4  (10.3)   56.7  (11.1)   56.6  (10.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 404   405   809 
Female      185  45.8%      177  43.7%      362  44.7% 
Male      219  54.2%      228  56.3%      447  55.3% 
Glycosylated haemoglobin (HbA1c) 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 404   405   809 
   8.36  (0.95)   8.33  (0.96)   8.35  (0.95) 
Body Weight 
[Units: Kilogram (s)]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 404   405   809 
   96.21  (22.5)   95.37  (20.46)   95.79  (21.49) 
Fasting Plasma Glucose [1] 
[Units: Mg/ dL]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 383   384   767 
   190.5  (48.06)   187.5  (49.41)   189.0  (48.74) 
[1] The number of subjects analysed in the semaglutide and exenatide arms was 383 and 384, respectively.
Systolic blood pressure [1] 
[Units: Mm Hg]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 404   404   808 
   133.35  (14.87)   133.66  (14.25)   133.51  (14.55) 
[1] The number of subjects analysed in the semaglutide and exenatide arms was 404 and 404, respectively.
Diastolic blood pressure [1] 
[Units: Mm Hg]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 404   404   808 
   80.23  (8.67)   79.57  (8.8)   79.90  (8.73) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 403   405   808 
   27.35  (6.55)   27.23  (6.62)   27.29  (6.58) 
[1] 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] The number of subjects analysed in the semaglutide and exenatide arms was 403 and 405, respectively.


  Outcome Measures

1.  Primary:   Change From Baseline in HbA1c (Glycosylated Haemoglobin)   [ Time Frame: Week 0, week 56 ]

2.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Week 0, week 56 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG)   [ Time Frame: Week 0, week 56 ]

4.  Secondary:   Change From Baseline in Systolic and Diastolic Blood Pressure   [ Time Frame: Week 0, week 56 ]

5.  Secondary:   Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)   [ Time Frame: Week 0, week 56 ]

6.  Secondary:   Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)   [ Time Frame: After 56 weeks' 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: 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: March 30, 2018