December 3, 2007
View Full PaperExenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years
Key Result
Adjunctive exenatide treatment for ≥3 years in patients with type 2 diabetes resulted in sustained reductions in A1C (-1.0%; p<0.0001) and progressive weight loss (-5.3 kg; p<0.0001).
Study Design
Type
RCT (n=217)
Blinding
Open-label
Randomization
randomized
Structured PICO
Does exenatide improve glycemic control, body weight, and cardiometabolic markers in patients with type 2 diabetes over >= 3 years?
P
Population
217 patients with type 2 diabetes (mean age 58 years, 36% female) treated with adjunctive exenatide and followed for at least 3 years.
I
Intervention
Exenatide 10 mcg twice daily (BID) for >= 3 years (after initial titration of 5 mcg BID for 4 weeks), added to metformin and/or sulfonylureas.
O
Outcome
Glycemic control (A1C), body weight, cardiometabolic markers, and safety at >= 3 years.surrogate
Long-term adjunctive exenatide therapy for over 3 years in patients with type 2 diabetes provides sustained improvements in glycemic control, weight reduction, and cardiometabolic markers.
Main Result
p-value: p=< 0.0001
Limitations
- Open-label, uncontrolled nature of the study design which does not provide a placebo group for comparison
Abstract
BACKGROUND: Exenatide, an incretin mimetic for adjunctive treatment of type 2 diabetes (T2DM), reduced hemoglobin A(1c) (A1C) and weight in clinical trials. The objective of this study was to evaluate the effects of > or = 3 years exenatide therapy on glycemic control, body weight, cardiometabolic markers, and safety. METHODS: Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended, open-label clinical trial. Patients were randomized to twice daily (BID) placebo, 5 mug exenatide, or 10 mug exenatide for 30 weeks, followed by 5 mug exenatide BID for 4 weeks, then 10 mug exenatide BID for > or = 3 years of exenatide exposure. Patients continued metformin and/or sulfonylureas. RESULTS: 217 patients (64% male, age 58 +/- 10 years, weight 99 +/- 18 kg, BMI 34 +/- 5 kg/m(2), A1C 8.2 +/- 1.0% mean +/- SD) completed 3 years of exenatide exposure. Reductions in A1C from baseline to week 12 (-1.1 +/- 0.1% mean +/- SEM) were sustained to 3 years (-1.0 +/- 0.1%; p or = 3 years in T2DM patients resulted in sustained improvements in glycemic control, cardiovascular risk factors, and hepatic biomarkers, coupled with progressive weight reduction.