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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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