Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
Study identifier:2993-116
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, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus
Medical condition
Diabetes Mellitus, Non-Insulin-Dependent
Phase
Phase 2
Healthy volunteers
No
Study drug
Placebo 0.01 mL, Placebo 0.02 mL, Placebo 0.03 mL, Placebo 0.04 mL, AC2993 2.5 mcg, AC2993 5.0 mcg, AC2993 7.5 mcg, AC2993 10.0 mcg
Sex
All
Actual Enrollment
156
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Aug 2002
Primary Completion Date: 01 May 2003
Study Completion Date: 01 May 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 Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo 0.01 mL 2 week placebo lead-in followed by Placebo 0.01 mL | Drug: Placebo 0.01 mL 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily |
| Placebo Comparator: Placebo 0.02 mL 2 week placebo lead-in followed by Placebo 0.02 mL | Drug: Placebo 0.02 mL 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily |
| Placebo Comparator: Placebo 0.03 mL 2 week placebo lead-in followed by Placebo 0.03 mL | Drug: Placebo 0.03 mL 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily |
| Placebo Comparator: Placebo 0.04 mL 2 week placebo lead-in followed by Placebo 0.04 mL | Drug: Placebo 0.04 mL 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily |
| Experimental: AC2993 2.5 mcg 2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL | Drug: AC2993 2.5 mcg 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily Other Name: synthetic exendin-4 |
| Experimental: AC2993 5.0 mcg 2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL | Drug: AC2993 5.0 mcg 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily Other Name: synthetic exendin-4 |
| Experimental: AC2993 7.5 mcg 2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL | Drug: AC2993 7.5 mcg 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily Other Name: synthetic exendin-4 |
| Experimental: AC2993 10.0 mcg 2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL | Drug: AC2993 10.0 mcg 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily Other Name: synthetic exendin-4 |
