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

Abstract

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 baseline 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 that the proportion of patients achieving HbA_1c<7.0% was 50% (mean HbA_1cpy for up to 24 months. Addressing clinical inertia could improve disease outcomes and, possibly, economic burden.