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Long-Term Safety of Exenatide in Type 2 Diabetes
NCT01876849Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2003
- Primary completion
- Jul 2008
- Countries
- 1
- Sponsor
- AstraZeneca
- Modality
- Peptides
- Drugs
- exenatide
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, open-label, single-arm trial of exenatide in type 2 diabetes mellitus (T2DM), sponsored by AstraZeneca. Primary endpoint: Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events at 128 weeks. Started Dec 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Group A
Exenatide injection 5mcg or 10 mcg, twice daily
03
Who it enrols
Patients who completed exenatide therapy in Study H8O-MC-GWAA or Study H8O-MC-GWAD.
04
Endpoints
Primary
Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events
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