Safety and Efficacy of Exenatide as Monotherapy

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: exenatide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00381342

H8O-MC-GWBJ

Details and patient eligibility

About

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.

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Have previously completed or withdrawn from this study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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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233 participants in 3 patient groups, including a placebo group

Exenatide 5 mcg/exenatide 5 mcg

Experimental group

Description:

Exenatide 5 mcg; then exenatide 5 mcg

Treatment:

Drug: exenatide

Drug: exenatide

Exenatide 5 mcg/exenatide 10 mcg

Experimental group

Description:

Exenatide 5 mcg, then exenatide 10 mcg

Treatment:

Drug: exenatide

Drug: exenatide

Placebo

Placebo Comparator group

Description:

Placebo in volumes equivalent to exenatide

Treatment:

Drug: placebo