| Trial ID: | L5177 |
| Source ID: | NCT00359879
|
| Associated Drug: |
Exenatide
|
| Title: |
Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: exenatide|DRUG: exenatide
|
| Outcome Measures: |
Primary: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12, Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12, Baseline, Week 12 | Secondary: Change in body weight from Baseline to Week 12, and if measured, at each visit, Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8), Baseline, Weeks 4, 8, 12|Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit, Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8), Baseline, Weeks 4, 8, 12|Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12, Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime), Baseline, Weeks 4, 8, 12
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
377
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-09
|
| Completion Date: |
2007-07
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-23
|
| Locations: |
Research Site, Campinas, Brazil|Research Site, Curitiba, Brazil|Research Site, Fortaleza, Brazil|Research Site, Goiania, Brazil|Research Site, Porto Alegre, Brazil|Research Site, Rio de Janeiro, Brazil|Research Site, Salvador, Brazil|Research Site, Sao Jose Do Rio Preto, Brazil|Research Site, Sao Paulo, Brazil|Research Site, Guadalajara, Jalisco, Mexico|Research Site, Monterrey, Nuevo Leon, Mexico|Research Site, Merida, Yucatan, Mexico|Research Site, Aguascalientes, Mexico|Research Site, Mexico City, Mexico|Research Site, San Luis Potosi, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT00359879
|
