Safety and Efficacy of Exenatide in Patients with Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Study identifier:H8O-MC-GWBA
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Safety and Efficacy of Exenatide in Patients with Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 3
Healthy volunteers
No
Study drug
exenatide, Placebo
Sex
All
Actual Enrollment
466
Study type
Interventional
Age
21 Years - 75 Years
Date
Study Start Date: 01 Jan 2006
Primary Completion Date: 01 Apr 2007
Study Completion Date: 01 Apr 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Eli Lilly and Company
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks | Drug: exenatide subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks Other Name: Byetta |
| Placebo Comparator: Placebo Placebo in volume equal to exenatide | Drug: Placebo subcutaneous injection twice daily in volumes equal to exenatide |
Contacts
Investigators
Principal Investigator
James Malone
Eli Lilly and Company
