Study identifier:H8O-MC-GWAK
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Type 2 Diabetes Mellitus
Phase 2
No
exenatide, Insulin
All
49
Interventional
35 Years - 70 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Eli Lilly and Company
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).
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.
Location
Location
Nashville, TN, United States
Location
San Antonio, TX, United States
Location
Chula Vista, CA, United States
Location
Portland, OR, United States
Location
Butte, MT, United States
Arms | Assigned Interventions |
---|---|
Experimental: Exenatide The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy. | Drug: exenatide Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks. Other Name: synthetic exendin-4 Other Name: AC2993 Other Name: Byetta |
Active Comparator: Insulin The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy. | Drug: Insulin Insulin will be taken according to the subject's current regimen |
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