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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)

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: June 20, 2013
Last updated: September 23, 2016
Last verified: September 2016
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: semaglutide
Drug: exenatide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 56 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 813
Study Start Date: December 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Semaglutide 1.0 mg Drug: semaglutide
One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly
Active Comparator: Exenatide ER 2.0 mg Drug: exenatide
One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly
Other Name: Bydureon®


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01885208

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Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01885208     History of Changes
Other Study ID Numbers: NN9535-3624
2012-004826-92 ( EudraCT Number )
U1111-1135-8647 ( Other Identifier: WHO )
Study First Received: June 20, 2013
Last Updated: September 23, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 22, 2017