An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT01876849
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group A exenatide Exenatide injection 5mcg or 10 mcg, twice daily
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇺🇸Renton, Washington, United States