Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: exenatide (Drug); Insulin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company
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).
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16
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.
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
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.
Locations and Contacts
Research Site, Chula Vista, California, United States
Research Site, Butte, Montana, United States
Research Site, Portland, Oregon, United States
Research Site, Nashville, Tennessee, United States
Research Site, San Antonio, Texas, United States
Additional Information
Starting date: February 2004
Last updated: February 20, 2015
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