Type 2 Diabetes Mellitus
Conditions
Keywords
exenatide, exendin-4, Amylin, Eli Lilly, diabetes
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.
Interventions
DRUGexenatide
Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.
DRUGInsulin
Insulin will be taken according to the subject's current regimen
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16 | Baseline, Week 16 | Change in HbA1c from Baseline study termination (Week 16) |
Countries
United States
Outcome results
None listed