Abstract / Summary
Introduction: Type 2 diabetes mellitus (T2DM) is a major global health burden, particularly in India.Pioglitazone is an established thiazolidinedione insulin sensitizer.It is contraindicated in heart failure and is clinically unsuitable for many patients with edema, osteoporosis, or bladder cancer risk, creating a therapeutic gap.Saroglitazar, a dual peroxisome proliferator-activated receptor (PPAR)-α/γ agonist approved in India for T2DM, diabetic dyslipidemia, and metabolic dysfunction-associated steatotic liver disease (MASLD), has insulin-sensitizing properties, but evidence in non-MASLD T2DM patients remains limited.Methods: This single-center, retrospective, real-world study analyzed the medical records of adults with T2DM who were deemed ineligible for pioglitazone and were initiated on saroglitazar 4 mg once daily as add-on therapy between June 2025 and March 2026.All consecutive eligible patients with documented follow-up at approximately 12 and 24 weeks were included (n = 60).Data on demographics, comorbidities, concomitant antidiabetic therapy and its modifications, glycated hemoglobin (HbA1c), fasting and postprandial blood glucose (FBG, PPBG), lipid profile, liver enzymes, serum creatinine, body weight, and adverse events were extracted from outpatient case records, electronic medical records, and laboratory reports using a standardized data collection form.Changes from baseline to 12 and 24 weeks were assessed using two-tailed paired t-tests with 95% confidence intervals (CIs); P < 0.05 was considered statistically significant.Results: Mean age was 56.15 ± 11.27 years, and 58.3% were female.HbA1c decreased significantly from 9.42 ± 1.53% at baseline to 8.21 ± 1.16% at 12 weeks and 7.06 ± 0.69% at 24 weeks (P < 0.001).Significant improvements occurred in FBG and PPBG, triglycerides, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and high-density lipoprotein cholesterol (HDL-C) (all P < 0.001).Liver enzymes and serum creatinine stayed within normal ranges, and body weight remained stable.Dose reduction or discontinuation of concomitant antihyperglycemic therapy occurred in 36.7% of patients; among the 12 insulin-treated patients, insulin was discontinued in eight (66.7%) and down-titrated in 2 (16.7%) (combined, 83.3%).No documented adverse events were identified in the retrospective records.Conclusion: Saroglitazar was associated with significant improvements in glycemic and lipid parameters without weight gain in non-MASLD T2DM patients ineligible for pioglitazone.Given the uncontrolled retrospective design and concurrent modification of background antihyperglycemic therapy, these findings should be considered hypothesis-generating and warrant prospective evaluation of saroglitazar as an insulin-sensitizing option in this population.