The safety and efficacy of metformin and glimepiride combination among Filipinos with type 2 diabetes mellitus
- Author:
Grace K. Delos Santos
- Publication Type:Journal Article
- From:
Philippine Journal of Internal Medicine
2011;49(1):51-56
- CountryPhilippines
- Language:English
-
Abstract:
Objective: To assess the safety and efficacy of combining metformin with glimepiride (Solosa®) in the treatment of patients with type 2 diabetes uncontrolled with metformin monotherapy. Methods: Solosa Intensive Diabetes Management study or SOLID is an open-label, multicenter, observational, post-marketing study. Patients with type 2 diabetes uncontrolled with metformin monotherapy for at least four weeks were included in the study. Glimepiride was added to metformin during the 3-month treatment period. Determination of HbA1c was done at baseline and at three months. Patients were followed-up based on the usual clinical practice and data were recorded in the case report form monthly during the three month observation period. During the last follow-up visit, global assessment of the treatment by the patient and physician was recorded. Results: One thousand six hundred thirty-eight (1638) patients were enrolled in the study and 1551 patients were included into the intention-to-treat (ITT) population for the safety analysis. The mean duration of diabetes for the study population was 3.29 years with mean glycosylated haemoglobin (HbA1C) and Fasting Blood Glucose (FBG) level s of 8.41% and 175.89 mg/dl respectively. The patients received a median dose of 1500mg of metformin and 2mg of glimepiride. Fifty-seven (3.68%) patients reported adverse events. None of them required treatment cessation. Only four of the events were deemed related to the study treatment. The rate of incidence of hypoglycaemia was 2.71%. Mean HbA1c after 3 months was 6.82% while mean Fasting Plasma Glucose (FPG) was 122.8 mg/dl. Almost 90% of patients (88.16%) and physicians (87.03%) assessed the combination treatment of metformin and glimepiride as “Good” in terms of tolerability. Conclusion: The study showed that the use of metformin and glimepiride combination in the treatment of type 2 diabetes mellitus is both safe and effective.
