A CLINICAL STUDY ON ADVERSE DRUG REACTIONS OF COMBINATION THERAPY OF DAPAGLIFLOZIN AND METFORMIN IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS

Abstract

ABSTRACTObjective: This study aimed at determination of safety and efficacy of combination therapy of dapagliflozin and metformin in the treatment of Type2 diabetes mellitus.Methods: A total of 50 patients were enrolled in the study depending on demographic parameters and clinical data of the patients. The primaryefficacy criterion was the change in glycated hemoglobin (HbA1c) after a minimum of 12 weeks of treatment. Secondary efficacy parameters wereHbA1c value after 12 weeks, fasting and 1 hrs postprandial glucose, serum insulin and triglyceride levels, after a standardized meal, all after 12 weeksof treatment. Safety and tolerability were evaluated by the incidence of adverse events reported by patients. Patient visits to the clinical center werescheduled at screening, start of the run-in period.Results: Reductions in levels of postprandial plasma glucose were observed in all the active treatment groups. The reductions in patients receivingmetformin plus dapagliflozin combination therapy were significantly greater (p<0.0001). It was clear that lower postprandial plasma insulin levelsdespite higher postprandial plasma glucose levels suggest decreased β-cell function. Changes in fasting serum insulin observed from baseline to theend of treatment did not differ significantly between metformin plus dapagliflozin combination therapy and metformin monotherapy and showed noconsistent trend.Conclusion: The results from the study suggest that the combination of the drugs was effective in controlling glycemic levels and also were safe. Noserious adverse drug reactions were reported by the patients when used daily once for 6 months.Keywords: Dapagliflozin, Metformin, Postprandial and glycemic.