"Efficacy and safety of saroglitazar on vascular function in patients with type 2 diabetes mellitus: A randomized, double blind, parallel arm, placebo controlled trial"

The Institute EthicsCommittee approval will be obtained. CTRI Registration will be done. Eligible patients will be includedand written informed consent will be taken. Following brief history taking andphysical examination, the patients will be randomized to receive either tabletSaroglitazar 4 mg od or similar looking placebo as add ontherapy for 3 months in addition to the standard background treatment ofmetformin and sulfonylureas. Carotid femoral (aortic) pulse wave velocity and other parameters of vascular functions will be measured at baseline and every month during follow up visitsfor a period of 3 months. 7 ml of venous bloodwill be taken under sterile precautions to assess fasting and postprandialblood glucose, lipid profile, liver and renal function tests and markers ofendothelial function namely ICAM, VCAM, E-selectin, IL-6, at baseline and after3 months of study period.4 ml of venous blood will be taken at first and secondmonths to measure fasting plasma glucose and postprandial blood glucose, Liverand Renal Function Test. During every monthfollow up visits, the patients will be enquired about adherence and adversedrug reactions to saroglitazar. Change in anti diabetic medications, if any,will be recorded during all three follow up visits. Blood glucose monitoring(Fasting and postprandial blood glucose) will be done every month for theperiod of 3 months for clinical management of participants. Type 2 diabetespatients who have dyslipidemia (Cholesterol > 200 mg/dL and triglycerides> 150 mg/dl) will be started with statins, irrespective of the interventiongroup to which they are randomized.