Safety and Efficacy of Exenatide as Monotherapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.

Key facts

Study ID

NCT00381342

Run by

AstraZeneca

People needed

233

Starts

2006-09-01

Expected to finish

2007-09-01

Last updated by the study team

2015-02-23

Who can join

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

You may qualify if…

• Diagnosed with type 2 diabetes
• Treating diabetes with diet and exercise
• HbA1c between 6.5% and 10.0%, inclusive
• Body Mass Index (BMI) between 25 kg/m\^2 and 45 kg/m\^2, inclusive

You may not qualify if…

• Have previously completed or withdrawn from this study
• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
• Have been treated with any antidiabetic agent
• Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
• Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study

Where it is running

• Research Site — Idaho Falls, Idaho, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Aligarh, India
• Research Site — Bangalore, India
• Research Site — Chennai, India
• Research Site — Indore, India
• Research Site — Karnāl, India
• Research Site — New Delhi, India
• Research Site — Vellore, India
• Research Site — Manati, Puerto Rico
• Research Site — San Juan, Puerto Rico
• Research Site — Alba Iulia, Romania
• Research Site — Baia Mare, Romania
• Research Site — Bucharest, Romania
• Research Site — Galati, Romania
• Research Site — Oradea, Romania
• Research Site — Târgu Mureş, Romania
• Research Site — Moscow, Russia
• Research Site — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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