19.Comparative Analysis of Metformin and its Combination with Dapagliflozin in Type 2 Diabetes: Randomized Control Trial
Muhammad Kamran Yousuf1, Mehar Fatima1, Sadaf Haris3, Hina Azfar4, Faryal Gul2 and Shahid Mustafa Memon5
ABSTRACT
Objective: The current clinical trial compared the effects of metformin monotherapy and dapagliflozin plus metformin combination in diabetic patients. The secondary objectives included estimating the effects of these regimens on safety and tolerability.
Study Design: Randomized clinical trial study
Place and Duration of Study: This study was conducted at the National Medical Center, Karachi, Pakistan from January – June 2020.
Materials and Methods: A total of 200 patients were recruited, had baseline FPG ≥ 126 mg/dL, and glycated hemoglobin A1c (HbA1c) ≥ 7.5- ≤10%. All the participants were divided into two groups: metformin (group A) and dapagliflozin plus metformin combination (group B). The study's primary endpoint was FBG and HbA(1c), and secondary included change in lipid profile, liver function test, renal function test, and urinalysis.
Results: The primary endpoints for combination therapy led to significantly greater reductions in FBG and HbA(1c) than metformin monotherapy. The change in FPG levels at week 12 in groups A and B were 184.05±14.82 vs. 101.40±16.85; p < 0.0001. The HbA(1c) change at week 12 in groups A and B was 7.83±0.54 vs. 6.91±0.74; p < 0.0001. Insignificant findings were observed for lipid profile, liver function test, renal function test, and urinalysis among both groups at the entire study.
Conclusion: This is the first randomized clinical trial in diabetic patients of Pakistan treated with and dapagliflozin-metformin combination. Combination therapy was generally well-tolerated and effective in reducing HbA(1c) and FPG relatively metformin monotherapy after initiation of therapy.
Key Words: β cell dysfunction, Dapagliflozin, hemoglobin A1c, Metformin, Type 2 diabetes mellitus
Citation of article: Yousuf MK, Fatima M, Haris S, Azfar H, Gul F, Memon SM. Comparative Analysis of Metformin and its Combination with Dapagliflozin in Type 2 Diabetes: Randomized Control Trial. Med Forum 2021;32(7):82-87.