Adequacy of Glycemic Control in Greek Patients with Type 2 Diabetes Mellitus Treated with Metformin Monotherapy at the Maximum Tolerated Dose: The Reload Study

OBJECTIVES: To assess adequacy of glycaemic control in Greek patients with type 2 diabetes mellitus (T2DM) treated with maximum tolerated doses of metformin. METHODS: RELOAD was a multi-centre, retrospective study in patients with T2DM treated with metformin only. Data were collected from the medical files of patients withT2DM diagnosed at an age >40 years who received metformin monotherapy at maximum tolerated doses for >24 months during the 5 years prior to enrolment. Demographic and clinical data were collected at metformin initiation, 9, 17-20 and 24 months. Primary endpoints were the percentage of patients achieving metabolic compensation (MC, reduction of HbAlc values from >6.5% at baseline to 6.5% while on metformin monotherapy and the mean time to treatment intensification. In pre-specified analysis the relationship of comorbidity to MC was explored. RESULTS: 316 patients with T2DM were enrolled in the study. Baseline (mean±SD) demographic and clinical characteristics were: age 65.8±10.4 years, T2DM duration 5.8±4.2 years, weight 84.4±15.9kg and HbAlc 7.2%±1.1%. 78% (247/316) of patients had HbAlc >6.5%. Following 9 months of metformin treatment, 36.4% (90/247) of patients achieved MC, with a mean HbAlc reduction of 1.3% [95% confidence interval [CI]:(-1.57,-0.95)]; mean metformin daily dose was 1,561±532 mg. Mean time of exposure to HbAlc >6,5% for the overall population was 24.3±15.0 months and time to treatment intensification was 30.6±9.5 months. The percentage of hypertensive patients achieving HbAlc 6.5% for a substantial period of time, indicating clinical inertia and an increased risk for diabetic complications.