Comparative Study of Efficacy and Safety of Saroglitazar vs Pioglitazone in Patients of Type 2 Diabetes Mellitus

Background: Type 2 Diabetes Mellitus (T2DM) is highly prevalent in India, with patients often presenting with both insulin resistance and atherogenic dyslipidemia. Pioglitazone, a selective PPAR-γ agonist, improves insulin sensitivity but is limited by adverse effects such as weight gain and edema. Saroglitazar, a novel dual PPAR-α/γ agonist with predominant PPAR-α activity, has shown promise in improving both glycemic and lipid parameters with a more favorable safety profile. Comparative data between these two agents in Indian patients remain limited. Methods: A prospective, randomized, open-label, comparative clinical trial was conducted over 12 months. A total of 120 patients with T2DM (HbA1c 7.0–9.0%) were randomized into two groups: Group S (Saroglitazar 4 mg once daily, n=60) and Group P (Pioglitazone 15 mg once daily, n=60). The primary endpoint was change in HbA1c at 12 months. Secondary endpoints included changes in fasting blood sugar (FBS), post-prandial blood sugar (PPBS), body weight, and incidence of adverse events. Results: Both groups demonstrated significant reductions in HbA1c, FBS, and PPBS over 12 months (p<0.0001). However, Saroglitazar achieved significantly greater reductions in HbA1c at 6 and 12 months (p=0.0350 and p=0.0461), lower FBS and lower PPBS at 6 and 12 months (p=0.0002, <0.0001). Adverse events were more frequent in the Pioglitazone group, with significantly higher incidence of edema (10 vs. 2, p=0.0295) and a trend toward greater weight gain (12 vs. 4, p=0.0575). Conclusion: Saroglitazar demonstrated superior long-term glycemic control and a more favorable safety profile compared to Pioglitazone in Indian patients with T2DM. Keywords: Type 2 Diabetes Mellitus, Saroglitazar, Pioglitazone, PPAR agonist, Glycemic control, Dyslipidemia, Randomized clinical trial