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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

June 20, 2013
June 24, 2013
December 21, 2017
March 30, 2018
March 30, 2018
December 2, 2013
July 13, 2015   (Final data collection date for primary outcome measure)
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 HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 56 ]
Complete list of historical versions of study NCT01885208 on ClinicalTrials.gov Archive Site
  • 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.
  • Change From Baseline in Body Weight [ Time Frame: Week 0, week 56 ]
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 56 ]
  • Change From Baseline in Systolic and Diastolic Blood Pressure [ Time Frame: Week 0, week 56 ]
  • Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) [ Time Frame: Week 0, week 56 ]
  • 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 ]
Not Provided
Not Provided
 
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
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)
This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: semaglutide
    One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly
  • Drug: exenatide
    One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly
    Other Name: Bydureon®
  • Experimental: Semaglutide 1.0 mg
    Intervention: Drug: semaglutide
  • Active Comparator: Exenatide ER 2.0 mg
    Intervention: Drug: exenatide
Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
813
798
July 13, 2015
July 13, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose
  • HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive)

Exclusion Criteria:

  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice)
  • Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
  • Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness
  • History of chronic or idiopathic acute pancreatitis
  • Screening calcitonin value equal to or above 50 ng/L (pg/mL)
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
  • Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
  • Acute coronary or cerebrovascular event within 90 days before randomisation
  • Heart failure, New York Heart Association (NYHA) class IV
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Croatia,   Finland,   France,   Germany,   Greece,   Italy,   Netherlands,   Puerto Rico,   Serbia,   Switzerland,   United Kingdom,   United States
 
 
NCT01885208
NN9535-3624
2012-004826-92 ( EudraCT Number )
U1111-1135-8647 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP