Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
Study identifier:2993-112
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With Metformin Alone
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 3
Healthy volunteers
No
Study drug
AC2993, Placebo
Sex
All
Actual Enrollment
336
Study type
Interventional
Age
16 Years - 75 Years
Date
Study Start Date: 01 Mar 2002
Primary Completion Date: 01 Jun 2003
Study Completion Date: 01 Jun 2003
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
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AC2993 5 mcg (0.02 mL) Placebo, then AC2993 5 mcg, then AC2993 5 mcg | Drug: AC2993 Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily Other Name: synthetic exendin-4 |
| Experimental: AC2993 10mcg (0.04 mL) Placebo, then AC2993 5 mcg, then AC2993 10 mcg | Drug: AC2993 Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily Other Name: synthetic exendin-4 |
| Placebo Comparator: Placebo 0.02 mL Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL | Drug: Placebo Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily |
| Placebo Comparator: Placebo 0.04 mL Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL | Drug: Placebo Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily |
