Pooled Analysis of Exenatide to Treat Type 2 Diabetes

San Diego—A pooled analysis of 16 studies found that patients with type 2 diabetes treated with exenatide twice daily or once weekly had significant improvements in hemoglobin A1c (HbA1c) level, fasting glucose, body weight, and systolic blood pressure. The HbA1c reductions were greater in patients taking the drug once weekly. The results were presented at the ADA meeting in a poster titled Clinical Outcomes in Patients with Type 2 Diabetes Treated with Exenatide Twice Daily or Once Weekly: Retrospective Analysis of Pooled Clinical Data Stratified by Age and Duration of Diabetes. The US Food and Drug Administration has approved exenatide twice daily for patients with type 2 diabetes as a monotherapy or as an adjunctive therapy to metformin, sulfonylurea, thiazolidinedione, a combination of metformin and sulfonylurea, and a combination of metformin and thiazolidinedione. Exenatide is a glucagon-like peptide-1 receptor agonist. In this study, the authors included 12 randomized, controlled trials comparing exenatide twice daily with placebo or insulin in 1877 patients for ≥24 weeks. Patients received 5 mcg of exenatide twice daily for 4 weeks and then 10 mcg of exenatide twice daily for the following weeks. The authors also examined 4 randomized, controlled trials comparing exenatide once weekly with exenatide twice daily, sitagliptin, pioglitazone, or insulin in 670 patients for ≥24 weeks. Patients received 2 mg of exenatide once weekly for the duration of the study. In each of the 16 trials, patients managed their disease with diet and exercise with or without oral antihyperglycemic drugs. The authors assigned each patient to groups based on age (<65 years or ≥65 years) and duration of diabetes (<10 years or ≥10 years). In the exenatide twice-daily analysis, 1411 patients were <65 years of age and 466 patients were ≥65 years of age. In addition, there were 1250 patients who had diabetes for <10 years and 627 with diabetes for ≥10 years. In all of the subgroups, patients taking exenatide had a significant reduction in fasting glucose, body weight, systolic blood pressure, total cholesterol, and triglycerides compared with the placebo group. In the exenatide once-weekly analysis, 549 patients were <65 years of age and 121 patients were ≥65 years of age. In addition, there were 496 patients who had diabetes for <10 years and 174 with diabetes for ≥10 years. In all of the subgroups, patients taking exenatide had a significant reduction in fasting glucose, body weight, systolic blood pressure, total cholesterol, and triglycerides compared with the placebo group. In each subgroup (age and duration of disease), the most common adverse events were gastrointestinal. Patients taking exenatide twice daily had a higher incidence of nausea and vomiting, while patients taking exenatide once weekly had more instances of injection site pruritus. Patients who took exenatide and a concomitant sulfonylurea had the highest incidence of hypoglycemia. This study was supported by Amylin Pharmaceuticals, Inc.