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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:December 2, 2013
End Date:July 13, 2015

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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 - 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.


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
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