24-PUB: Effectiveness and Safety of Saroglitazar on Hypertriglyceridemia and Glycemic Parameters in Type 2 Diabetes with Comorbidities: Six-Month Study in India (LEAD INDIA-V)

Introduction and Objective: Type 2 diabetes frequently presents with comorbidities including hypertension, obesity, hypertriglyceridemia, thyroid disorders, myocardial infarction, and chronic kidney disease. Hypertriglyceridemia is linked to insulin resistance and elevated blood glucose. This study evaluated the safety and efficacy of saroglitazar, a dual PPAR-α/γ agonist, in Indian adults with type 2 diabetes and comorbidities. Methods: This single-centre, single-arm, observational study included 350 patients with type 2 diabetes mellitus and comorbidities (hypertension, obesity, hypertriglyceridemia, thyroid disorders, myocardial infarction, or chronic kidney disease) who were prescribed 4 mg [NK1] saroglitazar for six months. All participants received appropriate anti-diabetic and other medications. Glycemic parameters, lipid profile, serum creatinine, and eGFR were assessed at baseline and six months. Results: Participants were predominantly male (n=248, 70.86%) with mean age 53.29±14.08 years and median diabetes duration of ten years. After six months, HbA1c reduced from 9.39±4.58% to 7.52±1.27% (p<0.0001), fasting blood sugar from 187.05±77.69 to 123.19±39.12 mg/dl (p<0.0001), and random blood sugar from 246.04±101.93 to 174.22±57.53 mg/dl (p<0.0001). Triglycerides decreased from 358.36±202.71 to 182.06±102.49 mg/dl (49.2% reduction, p<0.0001). Serum creatinine remained stable (0.9±0.35 to 0.89±0.32 mg/dl, p=0.8126) and eGFR remained neutral (94.91±27.1 to 94.93±25.56, p=0.9758). The adverse drug reaction rate was low (7.71%). Conclusion: Saroglitazar demonstrated significant effectiveness in improving metabolic parameters with statistically significant declines in HbA1c and triglycerides. Stable renal function parameters indicate treatment was renal-safe. Low adverse drug reaction incidence suggests good tolerability.