The REALIZE Study, a retrospective observational analysis, assessed the effectiveness and safety of early initiation of a fixed-dose combination (FDC) of dapagliflozin (SGLT-2 inhibitor) and sitagliptin (DPP-4 inhibitor) in 250 Indian patients with type 2 diabetes mellitus (T2DM) across five centers. Eligible patients, aged 18-59 years with a BMI ≥25 kg/m² and HbA1c between 7.0% and 10.5%, were prescribed the FDC for 112 ± 20 days.
The study population, with a mean age of 46.9 years and predominantly male (58.8%), exhibited central adiposity (mean waist circumference 94.6 cm) and common comorbidities like dyslipidemia (37.6%) and hypertension (32%). Primary endpoints included changes in glycemic parameters (HbA1c, fasting plasma glucose [FPG], postprandial plasma glucose [PPG]), while secondary endpoints covered renal function (eGFR, serum creatinine, uACR), body weight, BMI, blood pressure, and triglycerides. Significant reductions were observed in HbA1c (-1.1%, p<0.001), FPG (-29.5 mg/dL), and PPG (-36.8 mg/dL), consistent across subgroups with hypertension or dyslipidemia. Renal parameters improved significantly, with eGFR increasing by 5.3 mL/min/1.73 m², serum creatinine decreasing by 0.5 mg/dL, and uACR dropping by 76.5 mg/g (all p<0.001).
Triglyceride levels decreased by 23.7 mg/dL (p=0.002), body weight reduced by 1.7 kg (p<0.001), and systolic/diastolic blood pressure decreased by 5.9/2.3 mmHg (p<0.001). No adverse events, including hypoglycemia or infections, were reported, supporting the FDC’s safety. The study aligns with prior research indicating superior efficacy of SGLT-2 and DPP-4 inhibitors in Asians and the benefits of FDCs in improving adherence (Wei et al., 2023).
Despite limitations like its retrospective design and short follow-up, the findings endorse early FDC use for holistic T2DM management, particularly in high-risk Indian patients with cardiometabolic comorbidities. Further prospective studies are needed to confirm long-term benefits.
Link: https://assets.cureus.com/uploads/original_article/pdf/404536/20251001-261097-2xrbt8.pdf
