A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

NCT00360334 · Completed

Last updated 2026-05-28

This study compares two diabetes treatments, exenatide and basal insulin, in adults with type 2 diabetes to see which helps more people reach a target blood sugar level with little or no weight gain.

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 235 people

Who can join Ages 30+ · all sexes

Timeline Started 2006-06 · est. completion 2008-04

Where 31 sites · United Kingdom

What this study is testing ClinicalTrials.gov NCT00360334 ↗

Description as written by the study sponsor.

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

Treatments tested

exenatide also known as Byetta Drug

subcutaneous injection, 5mcg or 10mcg, twice a day
insulin glargine also known as Lantus Drug

subcutaneous injection, titrated to target blood glucose level, once a day

Main thing measured	Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00360334 ↗