Hemant P Thacker, Ashu Rastogi, Jayesh K Bhatt, Krupi Parmar and Deven V Parmar
Bhatia Hospital, India
Post Graduate Institute of Medical Education and Research, India
Zydus Research Centre, India
Posters & Accepted Abstracts: J Diabetes Metab
Increased postprandial lipemia is associated with diabetic dyslipidemia and accelerates cardiovascular diseases. Saroglitazar is a dual PPAR?/? agonist with predominant PPAR alpha agonist activity, approved in India for the treatment of diabetic dyslipidemia. This trial was designed to evaluate the effects of Saroglitazar 4mg on postprandial lipemia in patients with type 2 diabetes. A 12- week, prospective, double-blind, placebo control study was developed to evaluate the effects of Saroglitazar 4mg on postprandial lipemia in 30 patients with type 2 diabetes mellitus at two investigational sites in India. Standardized 8 hours fat tolerance test was performed to measure the area under the curve (AUC) of plasma triglyceride level as a primary endpoint. Apo B48, Apo B100, lipid profile and glycemic control were measured at week 6 and week 12. Saroglitazar 4mg treatment showed a statistically significant reduction in postprandial TG-AUC concentration as compared to placebo (19.22 vs 4.76%; p<0.05) after 12 weeks of treatment. It also showed a statistically significant reduction in HbA1c (-0.32 ± 1.51 vs 1.21 ± 0.83; p<0.05) after 12 weeks of treatment. Saroglitazar treatment leads to a reduction in the concentration of triglyceride, VLDL cholesterol and fasting plasma glucose. However, it was not statistically significant. Overall, no safety concern was observed during the study. Saroglitazar has the potential to decrease postprandial triglyceride and may have further clinical implications in reducing cardiovascular risk in patients with type 2 diabetes mellitus.
E-mail: drhpt@hotmail.com
