Safety and Efficacy of Exenatide in Patients with Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
Study identifier:H8O-MC-GWAP
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 Thiazolidinediones or Thiazolidinediones and Metformin
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 3
Healthy volunteers
No
Study drug
exenatide, Placebo
Sex
All
Actual Enrollment
182
Study type
Interventional
Age
21 Years - 75 Years
Date
Study Start Date: 01 May 2004
Primary Completion Date: 01 Aug 2005
Study Completion Date: 01 Aug 2005
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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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide After a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen | Drug: exenatide After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units [5 μg] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units [10 μg] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy. Other Name: Byetta Other Name: AC2993 Other Name: synthetic exendin-4 |
| Placebo Comparator: Placebo After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen. | Drug: Placebo After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy. |
Contacts
Investigators
Principal Investigator
James Malone
Eli Lilly and Co.
