Bridging Glycemic and Lipid Control: Effects of Dapagliflozin in Co-Morbid Diabetes and Heart Failure – A Randomized Controlled Trial

Abstract

Introduction: Dapagliflozin, an SGLT2 inhibitor developed for Type 2 Diabetes Mellitus (T2DM), has shown multiple cardiovascular benefits. This study evaluated its effects on lipid profile and IR pattern in South Indian patients with T2DM and Heart Failure (HF).

Methods: This randomized trial was conducted over 180 days in 58 patients with T2DM and HF, assigned in a 1:1 ratio to standard therapy or standard therapy plus dapagliflozin 10 mg daily. Lipid, glycemic, and IR parameters were assessed at baseline, 12 weeks, and 24 weeks.

Results: Dapagliflozin group showed marked improvements in BMI (p = 0.01), TC (p = 0.02), TG (p = 0.01), HDL (p = 0.001), LDL (p = 0.002), and VLDL (p = 0.01), FPG (p = 0.0001), PPG (p = 0.002) and HbA1c (p = 0.01), HOMA-IR (p = 0.002), HOMA2%B (p = 0.003), and decreased insulin levels (p = 0.001) by 24 weeks. In contrast, significant changes were noted only in LDL (p = 0.01), HDL (p = 0.03), and TG (p = 0.01) in the standard group. A positive correlation was observed between the mean change in TG and HOMA-IR after 24 weeks of dapagliflozin treatment.

Discussion: Dapagliflozin improved lipid profile and reduced IR, demonstrating benefits in T2DM and HF patients, which aligned with the findings from the larger SGLT2i trials. Study limitations included the small sample size, single-center setting, and an open-label design.

Conclusion: Dapagliflozin improved lipid and IR, highlighting its potential as an adjunctive therapy in patients with co-morbid T2DM and HF.

Clinical trial number: CTRI/2024/01/06208.