Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

NCT00097500 · Completed

Last updated 2026-05-28

This clinical trial tested the effects of two diabetes medications, exenatide and insulin glargine, on people with type 2 diabetes over 52 weeks.

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 69 people

Who can join Ages 30–75 · all sexes

Timeline Started 2004-09 · est. completion 2009-12

Where 3 sites · Finland, Netherlands, Sweden

What this study is testing ClinicalTrials.gov NCT00097500 ↗

Description as written by the study sponsor.

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Treatments tested

exenatide also known as Byetta Drug

subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets
Insulin glargine also known as Lantus Drug

subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets
Metformin Drug

Patients usual dosage

Main thing measured	Beta-cell Function After 52 Weeks of Therapy
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00097500 ↗