Real-World Adequacy of Glycaemic Control in Treatment-Naive Greek Patients with Type 2 Diabetes Mellitus Initiating Treatment with Metformin Monotherapy at the Maximum Tolerated Dose: The Reload Study

Background Metformin, in the absence of contraindications or intolerance, is recommended as first-line treatment for patients with type 2 diabetes mellitus (T2DM). This observational, retrospective study assessed the real-world adequacy of glycaemic control in Greek patients with T2DM initiating metformin monotherapy at maximum tolerated dose. Methods Included patients received metformin monotherapy for >= 24 months; relevant patient data were collected immediately prior to metformin initiation (baseline) and at other prespecified time points. The primary objective was to report, after 9 months of metformin treatment, the percentage of patients with baseline glycated haemoglobin (HbA(1c)) levels >= 6.5 % (>= 48 mmol/mol) achieving HbA(1c) <6.5 %. Secondary objectives included the assessment of time spent with poor glycaemic control and time to treatment intensification. A sensitivity analysis assessed the percentage of patients with base- line HbA(1c) >= 7 % (>= 53 mmol/mol) achieving HbA(1c) < 7 % (<53 mmol/mol). Results Of the enrolled patients (N =316), 247 had baseline HbA(1c) >= 6.5%; following 9 months on metformin, 90 (36.4%) patients achieved HbA(1c) >= 6.5 % (mean HbA(1c) change- 1.3 % [ - 14 mmol/mol]). Median time of exposure to HbA(1c) >= 6.5% was 23.4 months and time to treatment intensification was 28.0 months. The sensitivity analysis revealed thatthe proportion of patients achieving HbA(1c) < 7.0 % was 50% (mean HbA(1c) change -1.6% [ -17 mmol/mol]). Conclusion Irrespective of HbA(1c) target assessed, most patients with T2DM do not achieve the recommended HbA(1c) goals after 9 months on metformin while remained on monotherapy for up to 24 months. Addressing clinical inertia could improve disease outcomes and, possibly, economic burden.