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

Abstract

ABSTRACT
Objective: This study aimed at determination of safety and efficacy of combination therapy of dapagliflozin and metformin in the treatment of Type
2 diabetes mellitus.
Methods: A total of 50 patients were enrolled in the study depending on demographic parameters and clinical data of the patients. The primary
efficacy criterion was the change in glycated hemoglobin (HbA1c) after a minimum of 12 weeks of treatment. Secondary efficacy parameters were
HbA1c value after 12 weeks, fasting and 1 hrs postprandial glucose, serum insulin and triglyceride levels, after a standardized meal, all after 12 weeks
of treatment. Safety and tolerability were evaluated by the incidence of adverse events reported by patients. Patient visits to the clinical center were
scheduled 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 receiving
metformin plus dapagliflozin combination therapy were significantly greater (p<0.0001). It was clear that lower postprandial plasma insulin levels
despite higher postprandial plasma glucose levels suggest decreased β-cell function. Changes in fasting serum insulin observed from baseline to the
end of treatment did not differ significantly between metformin plus dapagliflozin combination therapy and metformin monotherapy and showed no
consistent trend.
Conclusion: The results from the study suggest that the combination of the drugs was effective in controlling glycemic levels and also were safe. No
serious adverse drug reactions were reported by the patients when used daily once for 6 months.
Keywords: Dapagliflozin, Metformin, Postprandial and glycemic.