Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

NCT00099619 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of exenatide and insulin glargine on blood sugar control in adults with type 2 diabetes who are recommended to start insulin therapy.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 138 people

Who can join Ages 30+ · all sexes

Timeline Started 2004-09 · est. completion 2005-08

Where 26 sites · Australia, Greece, Hungary, Italy, Mexico, Poland

What this study is testing ClinicalTrials.gov NCT00099619 ↗

Description as written by the study sponsor.

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

Treatments tested

exenatide/insulin glargine also known as Byetta, AC2003, syntheitc exenden-4 Drug

Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels
insulin glargine/exenatide also known as Byetta, AC2993, synthetic exenden-4 Drug

Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks

Main thing measured	Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00099619 ↗