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).
RCT (n=217)
Open-label
randomized
Does exenatide improve glycemic control, body weight, and cardiometabolic markers in patients with type 2 diabetes over >= 3 years?
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.
p-value: p=< 0.0001
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.
Klonoff et al. (2007) conducted an RCT in Type 2 diabetes (n=217). Exenatide vs. Placebo (initially; uncontrolled at 3 years) was evaluated on Change in A1C from baseline to 3 years (p=< 0.0001). 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).