Safety and Efficacy of Exenatide as Monotherapy

NCT00381342 · Completed

Last updated 2026-05-28

This clinical trial tested the safety and effects of the medication exenatide, taken alone, in adults with type 2 diabetes to see how it impacts blood sugar levels over 24 weeks.

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 233 people

Who can join Ages 18+ · all sexes

Timeline Started 2006-09 · est. completion 2007-09

Where 19 sites · India, Puerto Rico, Romania, Russia, United States

What this study is testing ClinicalTrials.gov NCT00381342 ↗

Description as written by the study sponsor.

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.

Treatments tested

exenatide also known as Byetta Drug

Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
exenatide also known as Byetta Drug

Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day
placebo Drug

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

Main thing measured	Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00381342 ↗