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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01876849

Enrollment

275

Registered

2013-06-13

Start date

2003-12-31

Completion date

2008-07-31

Last updated

2015-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes, exenatide, Byetta, Amylin, Lilly

Brief summary

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.

Interventions

DRUGexenatide

subcutaneous injection, 5mcg or 10 mcg, twice daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients received exenatide therapy in Study H8O-MC-GWAA or Study H8O-MC-GWAD and completed the respective study.

Exclusion criteria

* Patients were excluded or discontinued early from Study H8O-MC-GWAA or Study H8O-MC-GWAD. * Patients have received treatment within the last 30 days with a drug, not including exenatide, that has not received regulatory approval for any indication at the time of study entry.

Design outcomes

Primary

Measure	Time frame	Description
Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events.	128 weeks (average treatment period)	Visits for this study occur at 6-mo (±2 wk) intervals until exenatide is approved for marketing.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026