Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents
- Registration Number
- NCT00099333
- Lead Sponsor
- AstraZeneca
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Inclusion Criteria
- Patients have been treated with insulin for >=3 months up to 12 years.
- HbA1c <=10.5%.
- Body mass index (BMI) between 27 kg/m2 and 40 kg/m2.
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Exclusion Criteria
- Patients previously received exenatide or GLP-1 analogs.
- Patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exenatide exenatide The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy. Insulin Insulin The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.
- Primary Outcome Measures
Name Time Method Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16 Baseline, Week 16 Change in HbA1c from Baseline study termination (Week 16)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇺🇸San Antonio, Texas, United States