Effect on Weight Loss of Exenatide Versus Placebo

NCT00375492 · Completed

Last updated 2026-05-28

This clinical trial tested whether the medication exenatide helps people with type 2 diabetes lose weight compared to a placebo.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 196 people

Who can join Ages 18–75 · all sexes

Timeline Started 2006-09 · est. completion 2008-02

Where 10 sites · United States

What this study is testing ClinicalTrials.gov NCT00375492 ↗

Description as written by the study sponsor.

This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.

Treatments tested

exenatide also known as Byetta Drug

subcutaneous injection, 5mcg or 10mcg, twice a day
placebo Drug

subcutaneous injection, volume equivalent to exenatide dose, twice a day

Main thing measured	Change From Baseline in Body Weight
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00375492 ↗