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 : June 13, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2||Drug: semaglutide Drug: exenatide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||813 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 - vs. QW GLP-1)|
|Actual Study Start Date :||December 2, 2013|
|Actual Primary Completion Date :||July 13, 2015|
|Actual Study Completion Date :||July 13, 2015|
|Experimental: Semaglutide 1.0 mg||
One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly
|Active Comparator: Exenatide ER 2.0 mg||
One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly
Other Name: Bydureon®
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 56 ]Mean change in HbA1c from baseline to week 56.
- Change From Baseline in Body Weight [ Time Frame: Week 0, week 56 ]Mean change in body weight from baseline to week 56.
- Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 56 ]Mean change in FPG from baseline to week 56.
- Change From Baseline in Systolic and Diastolic Blood Pressure [ Time Frame: Week 0, week 56 ]Mean changes in systolic and diastolic blood pressure from baseline to week 56.
- Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) [ Time Frame: Week 0, week 56 ]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.
- 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 ]The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885208
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Novo Nordisk A/S|
|Other Study ID Numbers:||
2012-004826-92 ( EudraCT Number )
U1111-1135-8647 ( Other Identifier: WHO )
|First Posted:||June 24, 2013 Key Record Dates|
|Results First Posted:||March 30, 2018|
|Last Update Posted:||June 13, 2019|
|Last Verified:||May 2019|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists