Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

NCT00111540 · Completed

Last updated 2026-05-28

This clinical trial is testing how well twice-daily exenatide controls blood sugar levels and its safety in adults with type 2 diabetes.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design open-label (no blinding) treatment study

Participants 456 people

Who can join Ages 18–70 · all sexes

Timeline Started 2002-11 · est. completion 2006-09

Where 60 sites · United States

What this study is testing ClinicalTrials.gov NCT00111540 ↗

Description as written by the study sponsor.

This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.

Treatments tested

exenatide also known as Byetta, exendin-4, AC2993 Drug

subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination

Main thing measured	Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit
Sponsor	AstraZeneca
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00111540 ↗