A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients with Type 2 Diabetes
Study identifier:H8O-JE-GWAV
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Dose Response Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 in Japanese Patients with Type 2 Diabetes Who are Treated with Oral Antidiabetic(s) but not well Controlled
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 2
Healthy volunteers
No
Study drug
exenatide (LY2148568), Placebo
Sex
All
Actual Enrollment
153
Study type
Interventional
Age
20 Years - 75 Years
Date
Study Start Date: 01 Sept 2006
Primary Completion Date: 01 May 2007
Study Completion Date: 01 May 2007
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
Eli Lilly and Company
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide 5 mcg/exenatide 10 mcg | Drug: exenatide (LY2148568) subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks Other Name: Byetta |
| Experimental: Exenatide 5 mcg/exenatide 5 mcg | Drug: exenatide (LY2148568) subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks Other Name: Byetta |
| Experimental: Exenatide 2.5 mcg/exenatide 2.5 mcg | Drug: exenatide (LY2148568) subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks Other Name: Byetta |
| Placebo Comparator: Placebo/placebo | Drug: Placebo subcutaneous injection twice daily, 0.02 mL to 0.04 mL |
Contacts
Investigators
Principal Investigator
James Malone
Eli Lilly and Company
