Study identifier:H8O-JE-GWBW
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Multiple-Dose Study to Examine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2148568 Long-Acting Release in Japanese Patients with Type 2 Diabetes Mellitus
Type 2 Diabetes
Phase 1
No
exenatide once weekly, placebo
All
30
Interventional
20 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Eli Lilly and Company
Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide once weekly in Japanese patients. This study is designed to evaluate safety and tolerability of exenatide once weekly in Japanese patients and determine whether the dose selected for US and European development is appropriate for Japanese patients with Type 2 diabetes.
Location
Location
Osaka, Japan
Location
Tokyo, Japan
Location
Kanagawa, Japan
Location
Fukuoka, Japan
Arms | Assigned Interventions |
---|---|
Experimental: 1 exenatide once weekly, 0.8mg | Drug: exenatide once weekly subcutaneous injection, once weekly |
Experimental: 2 exenatide once weekly, 2.0mg | Drug: exenatide once weekly subcutaneous injection, once weekly |
Placebo Comparator: 3 volume equivalent to 0.8mg of exenatide once weekly | Drug: placebo subcutaneous injection, once weekly |
Placebo Comparator: 4 volume equivalent to 2.0mg of exenatide once weekly | Drug: placebo subcutaneous injection, once weekly |
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