Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
Study identifier:2993-120
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 2
Healthy volunteers
No
Study drug
Placebo 0.04 mL twice daily, Placebo 0.04 mL once daily, Placebo 0.08 mL once daily, B - Exenatide 10 mcg twice daily, C - Exenatide 10 mcg once daily, Exenatide 20 mcg once daily
Sex
All
Actual Enrollment
99
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Sept 2003
Primary Completion Date: 01 Jan 2004
Study Completion Date: 01 Jan 2004
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 |
|---|---|
| Placebo Comparator: A1 - Placebo 0.04 mL twice daily | Drug: Placebo 0.04 mL twice daily Subcutaneously injected, 0.04 mL, twice daily |
| Placebo Comparator: A2 - Placebo 0.04 mL once daily | Drug: Placebo 0.04 mL once daily Subcutaneously injected, 0.04 mL, once daily |
| Placebo Comparator: A3 - Placebo 0.08 mL once daily | Drug: Placebo 0.08 mL once daily Subcutaneously injected, 0.08 mL, once daily |
| Experimental: B - Exenatide 10 mcg twice daily | Drug: B - Exenatide 10 mcg twice daily Subcutaneously injected, 10 mcg (0.04 mL), twice daily Other Name: ACC2993 Other Name: synthetic exendin-4 |
| Experimental: C - Exenatide 10 mcg once daily | Drug: C - Exenatide 10 mcg once daily Subcutaneously injected, 10 mcg (0.04 mL), once daily Other Name: ACC2993 Other Name: synthetic exendin-4 |
| Experimental: D - Exenatide 20 mcg once daily | Drug: Exenatide 20 mcg once daily Subcutaneously injected, 20 mcg (0.08 mL), once daily Other Name: ACC2993 Other Name: synthetic exendin-4 |
