Status:
COMPLETED
Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00099333
Start Date
February 1 2004
End Date
August 1 2005
Last Update
February 23 2015
Active Locations (5)
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1
Research Site
Chula Vista, California, United States
2
Research Site
Butte, Montana, United States
3
Research Site
Portland, Oregon, United States
4
Research Site
Nashville, Tennessee, United States