Factors Associated with First Injectable Glucose-Lowering Treatment in Patients with Type 2 Diabetes and 6-Month Treatment Outcomes: Data from the CHOICE Study in Germany

Aims: To observe time to, and factors associated with, significant treatment change among adults with type 2 diabetes in Germany initiating their first injectable therapy in routine practice, and to describe patient characteristics and clinical and patient-reported outcomes observed over 6 months. Methods: Ongoing prospective 24-month observational study (NCT00635492). Clinical data were collected before and after exenatide BID or insulin initiation. Results: On multivariate analysis of 848 patients (394 exenatide BID, 454 insulin), high BMI, hypoglycaemia and high triglyceride levels were positively associated with exenatide BID initiation; older age, high blood glucose levels and frequency of blood glucose monitoring were negatively associated with exenatide BID. Significant treatment changes were made in 20.7% of exenatide BID-cohort patients and 29.7% of insulin-cohort patients; discontinuation rates 15.5% and 4.1 %, respectively. At 6-month interim, mean (SE) HbA(1c) change from baseline was -0.8% (0.07 %) in the exenatide BID cohort (baseline 8.1 %) and - 1.6% (0.08%) in the insulin cohort (baseline 8.8 %). Mean body weight changes were - 3.5 kg and + 0.8 kg in exenatide BID and insulin cohorts, respectively. Gastrointestinal symptoms and hypoglycaemic episodes were reported by 19.7% and 2.3% of exenatide BID-cohort patients, respectively, and 2.5% and 11.3% of insulin-cohort patients, respectively during the first 6 months. Conclusions: Differences between patients initiating insulin and exenatide BID indicated that exenatide BID was favoured when weight gain and hypoglycaemia were of concern and when HbA1c was only modestly raised. At 6 months, discontinuation rate was higher in exenatide BID-treated patients. Treatment outcomes were consistent with clinical trial data.