COMPARISON OF EFFICACY OF DAPAGLIFLOZIN METFORMIN VERSUS SITAGLIPTIN METFORMIN IN NEWLY DIAGNOSED TYPE 2 DIABETES

Abstract

Background: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and progressive β-cell dysfunction, necessitating effective pharmacological interventions to achieve optimal glycemic control. While metformin is the first-line therapy, adjunct agents such as sodium-glucose co-transporter-2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors are increasingly utilized. Dapagliflozin, an SGLT2 inhibitor, has demonstrated glycemic benefits along with weight loss, whereas sitagliptin, a DPP-4 inhibitor, primarily enhances insulin secretion. Limited data exist comparing these two regimens in newly diagnosed T2DM patients, particularly in the Pakistani population.

Objective: To compare the efficacy and safety of dapagliflozin plus metformin versus sitagliptin plus metformin in newly diagnosed T2DM patients, focusing on glycemic control, weight loss, and adverse effects.

Methods: This randomized controlled trial was conducted at the Endocrinology Department of Nishtar Hospital, Multan, from March 2023 to August 2023. A total of 130 newly diagnosed T2DM patients aged 18–65 years with HbA1c between 7.0–10.0% and BMI 25–40 kg/m² were randomized 1:1 to receive either dapagliflozin (10 mg) plus metformin (500 mg twice daily) or sitagliptin (100 mg) plus metformin (500 mg twice daily) for 12 weeks. Primary outcome was the change in HbA1c, while secondary outcomes included fasting blood glucose (FBG), postprandial blood glucose (PPG), weight loss, lipid profile, and safety assessments. Statistical analysis was performed using SPSS version 26.0, with a p-value <0.05 considered statistically significant.

Results: The dapagliflozin-metformin group demonstrated significantly greater reductions in FBG (128.4 ± 18.5 mg/dL vs. 145.2 ± 21.4 mg/dL, p = 0.001), PPG (179.5 ± 24.7 mg/dL vs. 202.1 ± 26.2 mg/dL, p = 0.004), and HbA1c (7.4 ± 1.0% vs. 8.2 ± 1.2%, p = 0.001) compared to the sitagliptin-metformin group. Weight loss was also significantly greater in the dapagliflozin group (4.2 ± 1.5 kg vs. 1.8 ± 1.2 kg, p < 0.001). The incidence of urinary tract infections was higher in the dapagliflozin group (10.8% vs. 3.1%, p = 0.048), while other adverse effects were comparable between groups.

Conclusion: Dapagliflozin plus metformin was superior to sitagliptin plus metformin in improving glycemic control and promoting weight loss in newly diagnosed T2DM patients. These findings suggest that dapagliflozin may be a more effective early-stage treatment option, particularly for individuals requiring weight management. Further long-term studies are warranted to confirm these benefits and assess their durability over time.