A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.

Key facts

Study ID

NCT00877890

Run by

AstraZeneca

People needed

254

Starts

2009-03-01

Expected to finish

2010-01-01

Last updated by the study team

2015-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has been diagnosed with type 2 diabetes mellitus
• Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening
• Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
• Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening
• Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:
• Hormone replacement therapy (female subjects)
• Oral contraceptives (female subjects)
• Antihypertensive agents
• Lipid-lowering agents
• Thyroid replacement therapy
• Antidepressant agents
• Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over the counter antiobesity agents

You may not qualify if…

• Has ever been exposed to exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog
• Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
• Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
• Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening
• Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening
• Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
• Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Peoria, Arizona, United States
• Research Site — Artesia, California, United States
• Research Site — Concord, California, United States
• Research Site — Encino, California, United States
• Research Site — Greenbrae, California, United States
• Research Site — La Mesa, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — DeLand, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — New Port Richey, Florida, United States
• Research Site — Palm Harbor, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Avon, Indiana, United States
• Research Site — Evansville, Indiana, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Paducah, Kentucky, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Edina, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Butte, Montana, United States
• Research Site — New Hyde Park, New York, United States
• Research Site — Rochester, New York, United States

Full record on ClinicalTrials.gov

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