Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.

Key facts

Study ID

NCT00103935

Run by

AstraZeneca

People needed

45

Starts

2005-02-01

Expected to finish

2005-10-01

Last updated by the study team

2015-02-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has type 2 diabetes treated with either: *A stable regimen of metformin for a minimum of 3 months, and/or *Diet modification and exercise for a minimum of 3 months.
• Has HbA1c of 7.1% to 11.0%, inclusive.
• Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.

You may not qualify if…

• Received any investigational drug within 3 months prior to screening.
• Is currently treated with any of the following excluded medications: *Thiazolidinediones within 3 months of screening; * Sulfonylureas within 3 months of screening; * Insulin within 1 year of screening.
• Participated previously in an exenatide clinical study.

Where it is running

• Research Site — Walnut Creek, California, United States
• Research Site — Honolulu, Hawaii, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Butte, Montana, United States
• Research Site — Portland, Oregon, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Olympia, Washington, United States

Full record on ClinicalTrials.gov

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