| Trial ID: | L3368 |
| Source ID: | NCT00382239
|
| Associated Drug: |
Exenatide (Ly2148568)
|
| Title: |
A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: exenatide (LY2148568)|DRUG: exenatide (LY2148568)|DRUG: exenatide (LY2148568)|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12, Assess dose response effect on glucose control as measured by HbA1c among four doses (2.5 μg, 5 μg, 10 μg, and placebo) of subcutaneous injection of exenatide, twice daily before meals in the morning and evening, for 12 weeks, Baseline, Week 12 | Secondary: Proportion of subjects achieving HbA1c <7% at Week 12, Total number of subjects achieving HbA1c \<7% at Week 12, 12 weeks|Changes in fasting blood glucose from Visits 3 to 7, Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7), Baseline, Week 12|Change in Serum lipids from Baseline to Week 12, Changes in serum lipids (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) from Baseline (Visit 3) to Week 12 (Visit 7), Baseline, Week 12|Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12, Changes in body weight, waist size and waist/hip ratio from Baseline (Visit 3) to Week 12 (Visit 7), Baseline, Week 12
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
153
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-09
|
| Completion Date: |
2007-05
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-23
|
| Locations: |
Research Site, Fukuoka, Japan|Research Site, Fukushima, Japan|Research Site, Gunma, Japan|Research Site, Hiroshima, Japan|Research Site, Hyogo, Japan|Research Site, Ibaraki, Japan|Research Site, Kanagawa, Japan|Research Site, Kumamoto, Japan|Research Site, Kyoto, Japan|Research Site, Nagano, Japan|Research Site, Oita, Japan|Research Site, Okayama, Japan|Research Site, Osaka, Japan|Research Site, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00382239
|
