Safety and Efficacy of Exenatide as Monotherapy
Study identifier:H8O-MC-GWBJ
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients with Type 2 Diabetes
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 3
Healthy volunteers
No
Study drug
exenatide, placebo
Sex
All
Actual Enrollment
233
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Sept 2006
Primary Completion Date: 01 Sept 2007
Study Completion Date: 01 Sept 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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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide 5 mcg/exenatide 5 mcg Exenatide 5 mcg; then exenatide 5 mcg | Drug: exenatide Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day Other Name: Byetta |
| Experimental: Exenatide 5 mcg/exenatide 10 mcg Exenatide 5 mcg, then exenatide 10 mcg | Drug: exenatide Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day Other Name: Byetta |
| Placebo Comparator: Placebo Placebo in volumes equivalent to exenatide | Drug: placebo subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day |
Contacts
Investigators
Principal Investigator
James Malone
Eli Lilly and Company
