Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents
This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Exploratory Study of the Safety of Substituting Exenatide for Insulin in Patients With Type 2 Diabetes Who Have Been Using Insulin in Combination With Oral Antidiabetic Therapy|
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]Change in HbA1c from Baseline study termination (Week 16)
|Study Start Date:||February 2004|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy.
Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.
Active Comparator: Insulin
The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.
Insulin will be taken according to the subject's current regimen
This is an exploratory, multicenter, open-label, 2-arm, parallel trial. Approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy, will be randomized to discontinue insulin and substitute it with exenatide or remain on their current diabetes therapy regimen. All patients will continue their current diet and exercise regimen during the study.
|United States, California|
|Chula Vista, California, United States|
|United States, Montana|
|Butte, Montana, United States|
|United States, Oregon|
|Portland, Oregon, United States|
|United States, Tennessee|
|Nashville, Tennessee, United States|
|United States, Texas|
|San Antonio, Texas, United States|
|Study Director:||James Malone, MD||Eli Lilly and Company|