One-year metabolic outcomes in patients with type 2 diabetes treated with exenatide in routine practice

Aim. - The study objective was to analyze, in everyday practice, the long-term metabolic effects of exenatide (for 9 and 12 months) in patients with type 2 diabetes not responding to treatments with metformin and sulphonylurea at maximum dosages. Methods. - A total of 299 type 2 diabetics were recruited from 14 centres specializing in diabetes care across Belgium. Main study endpoints were changes in HbA(1c), weight and waist circumference, and tolerability and compliance. Two patient cohorts were analyzed for effectiveness, with data available at 9 (n = 90) and 12 (n = 94) months of follow-up. Results. Significant decreases in HbA(1c) of 1.3% and 1.6% were observed in the 9- and 12-month cohorts, respectively (P < 0.001). The decrease in HbA(1c) was greater in patients with higher baseline levels (P < 0.001), and the response was independent of baseline weight, body mass index (BMI), age, gender and diabetes duration. A progressive reduction of weight (4.9 kg) was also observed in the two cohorts at 9 and 12 months (P < 0.001), with greater weight loss in patients with higher baseline BMI (P = 0.046) and in female subjects (P = 0.025). Waist circumference also decreased from baseline to endpoints. A correlation was observed between reduction in HbA(1c) and weight loss (P = 0.019). Side effects, mainly of gastrointestinal origin, were reported in 33% (93/284 patients in the safety cohort). The rate of hypoglycaemia was 3.5%. Treatment was discontinued in 27% of patients (n = 77) mainly due to drug inefficacy (53%, n = 41) or adverse events (26%, n = 20), or both (8%, n = 6). Conclusion. - Exenatide leads to long-term improvement of glycaemic control as well as weight loss in a majority of patients not responding to combined oral drug therapy in real-world clinical practice. However, no baseline factors predictive of response could be identified. Exenatide can be considered an effective treatment option in such patients, including those with high baseline HbA(1c) and long duration of diabetes. (C) 2010 Elsevier Masson SAS. All rights reserved.