Dapagliflozin as an adjunct to insulin improves glycemic control, weight, and lipid profile with a superior safety profile in type 2 diabetes: a randomized trial.

OBJECTIVE: To investigate the efficacy and safety of dapagliflozin-insulin combination in patients with Type 2 Diabetes Mellitus (T2DM). METHODS: In this 3-month, randomized controlled trial, 86 T2DM patients were allocated to either insulin monotherapy (Group A) or dapagliflozin-insulin combination (Group B). Primary endpoints included glycemic control (Fasting Blood Glucose [FBG], 2-hour Postprandial Blood Glucose [2hPBG], Hemoglobin A1c [HbA1c]), lipid profile (Total Cholesterol [TC], Triglycerides [TG], Low-Density Lipoprotein Cholesterol [LDL-C], High-Density Lipoprotein Cholesterol [HDL-C]), anthropometrics (Body Mass Index [BMI], Body Weight [BW]), blood pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]), and adverse events. RESULTS: After treatment, the combination therapy (Group B) demonstrated significantly greater improvements than insulin alone (Group A). Reductions in Group B versus Group A were: HbA1c (24.9%vs. 10.3%), FBG (23.6%vs. 5.6%), 2hPBG (25.1%vs. 13.7%), TC (35.1%vs. 16.9%), TG (15.9%vs. 11.0%), LDL-C (15.7%vs. 6.5%), SBP (7.3%vs. 3.2%), DBP (12.6%vs. 7.8%), BMI (9.8%vs. 4.3%), and BW (5.4%vs. 3.3%); while HDL-C increased more in Group B (16.3%vs. 9.9%). Group B demonstrated superior benefits in glycemic control, lipid profile, anthropometrics parameters and blood pressure reductions. All post-treatment between-group comparisons were statistically significant (p < 0.05). Critically, the incidence of adverse events was 71.4% lower in Group B, a statistically significant difference (p = 0.007). CONCLUSIONS: Dapagliflozin as an adjunct to insulin provides superior multi-faceted metabolic benefits encompassing glycemic control, weight reduction, lipid improvement, and blood pressure lowering, coupled with a more favorable safety profile, supporting its inclusion in standard insulin regimens for T2DM.