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Trial record 1 of 1675 for:    SUSTAIN 5
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Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes (SUSTAIN™ 5)

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ClinicalTrials.gov Identifier: NCT02305381
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : February 16, 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted at 90 sites in 5 countries, as follows: Germany: 10 sites; Japan: 6 sites; Serbia: 4 sites; Slovakia: 5 sites; United States: 65.

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 received semaglutide 0.25 mg subcutaneous (sc) injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Semaglutide 1.0 mg Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30.Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Placebo Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.

Participant Flow:   Overall Study
    Semaglutide 0.5 mg   Semaglutide 1.0 mg   Placebo
STARTED   132   132   133 
Exposed   132   131   133 
Premature Discontinuation of Treatment   14 [1]   16 [2]   13 [1] 
COMPLETED   127 [3]   127 [3]   126 [3] 
NOT COMPLETED   5   5   7 
Unclassified                5                5                7 
[1] Subjects who prematurely discontinued treatment were allowed to continue participation in the trial.
[2] Subjects who prematurely discontinued treatment were allowed to continue participation in the trial
[3] Subjects who completed 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.
Analysis was performed on full analysis set which included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.

Reporting Groups
  Description
Semaglutide 0.5 mg Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Semaglutide 1.0 mg Subjects received semaglutide 0.25 mg sc injection once weekly for 4 weeks followed by semaglutide 0.5 mg once weekly for next 4 weeks and then semaglutide 1.0 mg once weekly up to week 30. Semaglutide injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Placebo Subjects received placebo (matched to semaglutide) sc injection once weekly for 30 weeks. Placebo injection was administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same day of the week during the trial.
Total Total of all reporting groups

Baseline Measures
   Semaglutide 0.5 mg   Semaglutide 1.0 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 132   131   133   396 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed   132   131   133   396 
   59.1  (10.3)   58.5  (9.0)   58.8  (10.9)   58.8  (10.1) 
Age, Customized 
[Units: Participants]
       
Adults (18-64 years)         
Participants Analyzed   132   131   133   396 
Adults (18-64 years)   93   102   86   281 
From 65-84 years         
Participants Analyzed   132   131   133   396 
From 65-84 years   39   29   46   114 
85 years and over         
Participants Analyzed   132   131   133   396 
85 years and over   0   0   1   1 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed   132   131   133   396 
Female      58  43.9%      54  41.2%      62  46.6%      174  43.9% 
Male      74  56.1%      77  58.8%      71  53.4%      222  56.1% 
Glycosylated haemoglobin 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
       
Participants Analyzed   132   131   133   396 
   8.36  (0.83)   8.31  (0.82)   8.42  (0.88)   8.37  (0.84) 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
       
Participants Analyzed   132   131   133   396 
   92.74  (19.57)   92.49  (22.23)   89.88  (21.06)   91.70  (20.97) 
Fasting plasma glucose 
[Units: mg/dL]
Mean (Standard Deviation)
       
Participants Analyzed   132   131   133   396 
   161.0  (62.38)   152.5  (50.91)   154.1  (46.66)   155.9  (53.68) 
Insulin dose [1] 
[Units: International unit]
Median (Full Range)
       
Participants Analyzed   131   131   133   395 
   35.00 
 (15.00 to 300.00) 
 36.00 
 (14.00 to 320.00) 
 36.00 
 (12.00 to 124.00) 
 36.00 
 (12.00 to 320.00) 
[1] Number of participants analysed=participants with available data for insulin dose at baseline.
Diastolic Blood Pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
       
Participants Analyzed   132   131   133   396 
   78.89  (9.72)   78.73  (9.98)   79.35  (9.71)   78.99  (9.79) 
Systolic Blood Pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
       
Participants Analyzed   132   131   133   396 
   134.87  (15.00)   134.40  (16.32)   134.99  (16.68)   134.76  (15.98) 
Diabetes Treatment Satisfaction Questionnaire [1] 
[Units: Scores on scale]
Mean (Standard Deviation)
       
Participants Analyzed   132   131   133   396 
   28.86  (6.35)   28.62  (6.45)   27.54  (6.55)   28.34  (6.46) 
[1] The DTSQs questionnaire was used to assess subjects’ treatment satisfaction and 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.


  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 Insulin Dose   [ Time Frame: week 0, week 30 ]

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

6.  Secondary:   Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)   [ Time Frame: week 0, week 30 ]

7.  Secondary:   HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target   [ Time Frame: After 30 weeks treatment ]

8.  Secondary:   HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target   [ Time Frame: After 30 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: Global Clinical Registry (GCR, 1452)
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


Publications of Results:
Rodbard H, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu P-L, Wijayasinghe N, Norwood P. Efficacy and safety of semaglutide once-weekly vs placebo as add-on to basal insulin alone or in combination with metformin in subjects with type 2 diabetes (SUSTAIN 5). Diabetologia. 2016; 59: S364-5.


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02305381     History of Changes
Other Study ID Numbers: NN9535-3627
2013-004502-26 ( EudraCT Number )
U1111-1149-3738 ( Other Identifier: WHO )
JapicCTI-142729 ( Other Identifier: JAPIC )
First Submitted: November 28, 2014
First Posted: December 2, 2014
Results First Submitted: December 14, 2017
Results First Posted: February 16, 2018
Last Update Posted: July 18, 2018