Study identifier:2993-115
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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 Twice Daily in Subjects With Type 2 Diabetes Mellitus Treated With Metformin and a Sulfonylurea
Diabetes Mellitus, Non-Insulin-Dependent
Phase 3
No
AC2993, Placebo
All
734
Interventional
16 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.
Location
Location
Anaheim, CA, United States, 92801
Location
Philadelphia, PA, United States, 19141
Location
Indianapolis, IN, United States, 46222
Location
Miami, FL, United States, 33176
Location
Lexington, KY, United States, 40509
Location
Charlotte, NC, United States, 28211
Location
Gainesville, FL, United States, 32605
Location
Clearwater, FL, United States, 33765
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 / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (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 |
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