Efficacy and safety of Dapagliflozin and Glimepiride in combination with Metformin: Randomized clinical trial

Abstract

Objective: To identify the effective treatment option between dapagliflozin-metformin and glimepiride-metformin combination in patients with type 2 diabetes who were inadequately controlled with metformin monotherapy. Study design and setting: The present study is randomized, conducted for 12 weeks at the National Medical center, Karachi, Pakistan. Methodology: The patients were divided into 2 treatment groups; group A was given dapagliflozin-metformin combination, while group B was given glimepiride-metformin combination. The efficacy endpoint of groups was estimated by hemoglobin A1c and fasting blood glucose levels at 0-, 6- and 12-week. While, safety endpoints were identified by analyzing liver function tests, lipid profile tests, renal function test, and urine analysis. The significant difference of data was analyzed by using statistical package of social sciences (SPSS) version 25. The parametric t-test and paired t-test were performed and considered p-value = 0.05 as statistical significant. Results: Baseline demographics, clinical features of diabetes, levels of liver enzymes, liver function test, renal function test, lipid profile, and urinalysis of randomized patients were similar in both treatment groups by showing p = 0.05. Followed by the initiation of the respective treatment, the baseline change of mean FBG and hemoglobin A1c levels with dapagliflozinmetformin combination was shown significantly reduce more compared to glimepiride-metformin combination (p = 0.05). Conclusion: Dapagliflozin-metformin combination therapy was superior and well-tolerated to regulate glycemic control as compare to glimepiride-metformin combination

Keywords

• type 2 diabetes mellitus, glimepiride, dapagliflozin, fasting blood glucose, glycated hemoglobin`