Study identifier:H8O-MC-GWBJ
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients with Type 2 Diabetes
Type 2 Diabetes Mellitus
Phase 3
No
exenatide, placebo
All
233
Interventional
18 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
Eli Lilly and Company
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.
Location
Location
Indianapolis, IN, United States
Location
Idaho Falls, ID, United States
Location
Manati, Puerto Rico
Location
San Juan, Puerto Rico
Location
Bucuresti, Romania
Location
Targu Mures, Romania
Location
Alba Iulia, Romania
Location
Galati, Romania
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 |
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