Efficacy and safety of glimepiride as initial treatment in Russian patients with type 2 diabetes mellitus

Abstract

Aim: To investigate the efficacy and safety of glimepiride as initial mono-therapy in type 2 diabetes patients (T2DM). Materials and Methods: This is a multi-center, open-label prospective observational study. 245 treatment-naïve T2DM patients, who had not achieved glycemic goals on lifestyle therapy during first 12 weeks after the diagnosis, were enrolled in this study. Antidiabetes treatment was initiated with glimepiride and continued during the 6-month follow-up period. Prescription of the initial dose (1 mg per day) and further dose adjustments were carried out by the attending physician in accordance with the glimepiride data sheet. Dynamics of HbA1c, fasting plasma glucose (FPG), 2 h postprandial blood glucose (2hPPG), weight and waist circumference, as well as the incidence of hypoglycemia were the evaluated parameters. Results: The baseline HbA1c (mean: 7.9±0.5%; female: 7.8±0.4%; male: 8.0±0.6%) was significantly reduced at week 12 (mean 7.2±0.6%, p<0.001; female: 7.1±0.5%; male: 7.2±0.6%), and at the final visit (6.6±0.7%, p<0.001; female: 6.6±0.7; male: 6.5±0.7). 71.7% of the subjects achieved the HbA1c target (<7%) at the end of the study. FPG and 2hPPG levels decreased by 2.3±1.3 mmol/L and 3.1±1.9 mmol/L, respectively (p<0.001). Of note, FPG and PPG at baseline were 8.2±1.2 mmol/L and 10.5±1.9 mmol/L, respectively. The incidence of hypoglycemia (as defined by BG ≤3.9 mmol/L in the presence of the relevant symptoms) was 10.2%. Nocturnal symptomatic hypoglycemia was observed in 1.6% of cases. No severe hypoglycemic events were reported. Body weight and BMI reduced by 1.0 kg and 0.4 kg/m2, respectively, during the follow-up period. The mean glimepiride daily dose at the end of the follow-up was 2.8±1.3 mg. Observed reduction in weight and low incidence of hypoglycemia could be attributed to continued effects of the lifestyle therapy and relatively short history of T2DM (average duration of diabetes was 1.4±2.4 years (median 0.5 years).Conclusion: Glimepiride effectively improved glycemic control in treatment-naïve T2DM patients over a 6-month period. The use of glimepiride in this population also showed a favorable safety profile. This data provides further rationale for the use of glimepiride for the initiation of pharmacological therapy in T2DM patients.