Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT00097500
- Lead Sponsor
- AstraZeneca
- Brief Summary
This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- Diagnosis of type 2 diabetes, but otherwise healthy
- HbA1c between 6.6% and 9.5%, inclusive.
- Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
- Treated with a stable dose of metformin for at least 2 months prior to screening.
- Patients previously in a study using exenatide.
- Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).
- Treated with insulin within 3 months of screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exenatide Arm Metformin Exenatide and Metformin Insulin Glargine Arm Insulin glargine Insulin Glargine and Metformin Insulin Glargine Arm Metformin Insulin Glargine and Metformin Exenatide Arm exenatide Exenatide and Metformin
- Primary Outcome Measures
Name Time Method Beta-cell Function After 52 Weeks of Therapy Baseline (week -2) and 52 weeks Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \[i.e., clamp time 290 min to 300 min\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline \[week -2\]).
- Secondary Outcome Measures
Name Time Method Change in Second Phase C-peptide Release baseline (-2 weeks), 52 weeks, and 56 weeks Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline \[week -2\]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.
Beta-cell Function 4 Weeks After Cessation of Therapy Baseline (week -2) and 56 weeks Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \[i.e., clamp time 290 min to 300 min\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline \[week -2\]).
Change in First Phase C-peptide Release baseline (week -2), 52 weeks, and 56 weeks Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline \[week -2\]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.
Seven Point Self Monitored Blood Glucose (SMBG) Measurements 0 weeks and 52 weeks SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).
M-value at Baseline, Week 52 and Week 56 baseline (week -2), 52 weeks, and 56 weeks M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.
Change in Fasting Plasma Glucose 0 weeks and 52 weeks Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).
Change in Body Weight 0 weeks and 52 weeks Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).
Change in Glycosylated Hemoglobin (HbA1c) Week 0 and week 52 Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).
Trial Locations
- Locations (1)
Research Site
🇸🇪Goteborg, Sweden
Research Site🇸🇪Goteborg, Sweden