Exenatide in Practice: A Six-Month Observational Trial

The incretin mimetic, exenatide, which lowers blood glucose by mimicking the effect of the glucagon-like peptide-1 (GLP-1) receptor agonist, was approved in April 2007 for combination therapy with metformin and/or sulfonylurea for type 2 diabetic patients in Germany. This clinical trial, which included five clinics, retrospectively analyzed the HbA(1c), weight and body mass index (BMI) in 100 type 2 diabetic patients (dosage after 4 weeks: 2 x 10 mu g/day) at outset and after six months of treatment with exenatide. The participants were categorized into four groups according to their HbA(1c) values at outset. After six months, the mean HbA(1c) values fell from 77 +/- 1.1% to 72 +/- 1.0% (Delta 0.5%; p 0.001). In patients with an HbA(1c) > 9% at outset (n = 15), the mean HbA(1c) decreased by 2%. The number of patients with an HbA(1c) < 7% increased from 24 at outset to 44 after six months (p < 0.001). The mean weight of the participants decreased from 108.3 +/- 19.6kg to 102.2 +/- 19.2 kg (Delta 6.1 kg; p < 0.001). In 45 patients, weight loss was more than 5%. BMI decreased from 373 +/- 6.5kg/m(2) to 35.1 +/- 6.3 kg/m(2) (Delta 2.2 kg/m(2); p < 0.001). Side effects were infrequent. Only 7% of the patients reported gastrointestinal side effects after the six months. A significant decrease in HbA(1c) and weight was seen after six months of treatment with exenatide. This effect was even more pronounced in the patients with higher HbA(1c) levels at outset.