A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus and High Body Mass Index (BMI)

The convergence of India's diabetes epidemic, high rates of obesity and MASLD, and the availability of pleiotropic SGLT2 inhibitors presents both an opportunity and a challenge for optimal diabetes management. While both dapagliflozin and empagliflozin provide significant benefits over and above glycemic control, the absence of direct comparative data in Indian populations limits evidence-based treatment decisions. This study aims to address these critical knowledge gaps by delivering comprehensive comparative effectiveness and cost-effectiveness data to inform clinical practice and healthcare policy in India.

Despite extensive evidence supporting the use of SGLT2 inhibitors, several important knowledge gaps remain, especially in relation to Indian clinical practice.

* Lack of head-to-head comparative data: No Indian randomized controlled trial has directly compared dapagliflozin and empagliflozin in terms of efficacy and safety in patients with type 2 diabetes mellitus (T2DM) and high body mass index. * Limited data on hepatic outcomes: While individual studies indicate liver benefits, no research has systematically compared the two agents using established hepatic assessment methods such as controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) via transient elastography. * Population-specific considerations: Indian patients may respond differently to SGLT2 inhibitors due to genetic polymorphisms affecting drug metabolism, distinct body composition patterns, and diverse dietary and lifestyle influences. * Economic evaluation gaps: There is a lack of comprehensive pharmacoeconomic analyses comparing these agents within the Indian healthcare system, which limits evidence-based formulary choices and reimbursement decisions. * Real-world effectiveness: While efficacy is proven in controlled trial settings, data on real-world effectiveness in Indian clinical practice conditions remain limited.

This study is uniquely positioned to address this gap by conducting a head-to-head, RCT of dapagliflozin vs. empagliflozin in Indian adults with T2DM and high BMI. The design ensures standardized background therapy, minimizes bias, and includes a comprehensive evaluation of metabolic (HbA1c, weight), hepatic (CAP and LSM), renal, and cardiovascular outcomes, as well as adverse events and patient-reported tolerability. Furthermore, it incorporates a pharmacoeconomic analysis using Average and Incremental Cost-Effectiveness Ratios (ACER, ICER) to assess affordability and value, a key consideration in India and other low- and middle-income countries (LMICs).

By generating robust, context-specific data on comparative efficacy and value of these agents, this study aims to fill a crucial knowledge gap and support personalized clinical decision-making. It is thus expected to make a meaningful contribution to optimizing diabetes care in India.

• Change in HbA1c (%) from baseline at 3 months [Срок оценки: From enrollment to the end of treatment at 3 months]
• Change in FBG (mg/dL) from baseline at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• Change in ALT from baseline at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• Changes in LSM from baseline at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• Change in SBP (mmHg) from baseline at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• Change in serum creatinine (mg/dL) from baseline at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• Incidence of adverse events from baseline at 6 month [Срок оценки: From enrollment to the end of treatment at 6 months]
• Incidence of Drug-related Discontinuation at 6 month [Срок оценки: From enrollment to the end of treatment at 6 months]
• Change in AST from baseline at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• Changes in CAP from baseline at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• Change in GGT from baseline at 6 months [Срок оценки: From enrollment to 6 months]
• Change in DBP (mmHg) from baseline at 6 months [Срок оценки: From enrollment to end of treatment at 6 months]