An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus

NCT01876849 · Completed

Last updated 2026-05-28

This study tested the long-term safety of twice-daily exenatide injections in adults with type 2 diabetes to monitor for any side effects.

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 275 people

Who can join Ages 30–75 · all sexes

Timeline Started 2003-12 · est. completion 2008-07

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT01876849 ↗

Description as written by the study sponsor.

The aim of this study is to assess the long-term safety of exenatide in patients with type 2 diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study H8O-MC-GWAD (12-month study). Study H8O-MC-GWAN serves as an open-ended extension to Studies H8O-MC-GWAA and H8O-MC-GWAD.

Treatments tested

exenatide also known as Byetta Drug

subcutaneous injection, 5mcg or 10 mcg, twice daily

Main thing measured	Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events.
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01876849 ↗