Safety and efficacy of the fixed-dose combination Of Glimepiride-Metformin in treating Type II Diabetes Mellitus (GLMET_L_05632): A real world experience

ABSTRACT

Introduction@#Diabetes in the Philippines is a major and growing health issue. From its prevalence of 2.8 million in 2000, it was projected by the World Health Organization to reach 7.8 million by 2030. Glimepiride has been found to be effective and well-tolerated, as monotherapy and in combination with metformin, in managing glycemic levels among type II diabetes mellitus (T2DM) patients. This study aimed to assess the safety and efficacy of a sustained release (SR) fixed-dose combination (FDC) preparation of glimepiride and metformin in the treatment of Filipino patients with T2DM.@*Methods@#This open-label, observational, multicenter, post-marketing study, conducted from April 2012 to December 2013, included 20 to 75-year-old patients with T2DM, presenting with 7% to 11% HbA1c or 110-250 mg/dL fasting blood sugar, insulin-naive, and in consideration for management with a glimepiride-metformin FDC. Baseline data were collected. Patients were prescribed with glimepiride-metformin FDC SR 2/500 mg/tab for a six-month treatment period. Follow-up data were collected on the third and the sixth month of treatment. Patients who missed one follow-up were included in population for safety analysis. Patients who completed both follow-up schedules make up the per-protocol population for efficacy analysis. Adverse events (AEs) were reported in frequencies and percentages. Repeated measures analysis of variance (ANOVA) was used for efficacy analysis on HbA1c and FBG data.@*Results@#From 1,052 enrollees, 795 patients had sufficiently filled data forms and attended at least one follow-up schedule; this is the population whose data was analyzed for this study. Fifty-nine AEs were reported; only 21 incidents of hypoglycemia were assessed to be definitely, probably, or possibly related to the study drug. Repeated measure ANOVA showed that the mean ± SD HbA1c at month three (7.15 ± 1.22%) and month six (6.80 ± 1.17%) were significantly lower than baseline (8.67 ± 1.10%). The mean ± SD FBG at month three (133.20 ± 35.46 mg/dL) and month six (122.47 ± 29.34 mg/dL) were also significantly lower than baseline (176.85 ± 41.24 mg/dL). The differences in HbA1c and FBG changes between those with concomitant OAD and those without were non-significant.@*Conclusion@#Fixed-dose combination of glimepiridemetformin is a drug with a tolerable profile and favorable benefits in treating patients with T2DM.