Comparative Study of Efficacy and Safety of Dapagliflozin vs Basal Insulin in Stabilizing Glycemic Variability in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Triple Drug Combination Therapy.

Wide variations in glucose levels may enhance oxidative stress and inflammation, sequentially resulting in endothelial cell damage. Insulin glargine, a basal insulin, is associated with good glycemic control with fewer events of hypoglycemia. Dapagliflozin is a selective inhibitor of sodium-glucose cotransporter 2 (SGLT-2) that reduces blood glucose by enhancing its urinary excretion. Continuous glucose monitoring (CGM) allows continuous assessment of interstitial glucose over time, allowing individualization of diabetes management.

Objective: To compare the efficacy and safety of dapagliflozin vs basal insulin in stabilizing glycemic variability (GV) in patients with type 2 diabetes mellitus (T2DM).

Materials and methods: A 1-year, prospective, randomized, open-label, single-center, double-arm, interventional clinical study was conducted at Deogiri Diabetes Care Centre, Aurangabad. About 100 patients with T2DM who were inadequately controlled on triple drug combination therapy were randomized into group A (N = 50), receiving dapagliflozin 10 mg once daily (OD), and group B (N = 50), receiving insulin glargine as the fourth glucose-lowering agent for 3 months. The "FreeStyle Libre Pro®" ambulatory glucose monitoring (AGM) sensor was used for the study to evaluate the coefficient of GV, time in range (TIR)%, time below range (TBR)%, time above range (TAR)%, and glucose management index (GMI).

Results: A significant reduction in the values of GV parameters (TIR, TAR, TBR, GMI, and coefficient of GV) and glycemic parameters like fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated hemoglobin (HbA1C), and change in body weight of patients was observed in both groups after 3 months of therapy.

Conclusion: Insulin glargine, as the fourth glucose-lowering agent on the background of a triple drug regimen, has demonstrated a significant reduction in GV compared to that observed with dapagliflozin.