A randomized comparative study of efficacy and safety of saroglitazar with fenofibrate in diabetic dyslipidemic patients on metformin and glimeperide


  • Syed Mohsin Ahmed Department of Pharmacology, Mysore Medical College and Research Centre, Irwin Road, Mysore 570001, Karnataka, India
  • Momin Mohd. Abdul Mujeeb Department of Pharmacology, Grand Government Medical College, Mumbai, Maharashtra, India




Diabetes mellitus, Diabetic dyslipidaemia, Fenofibrate, Saroglitazar


Background: This study was conducted to compare the efficacy and safety of saroglitazar with fenofibrate in Indian diabetic dyslipidemic patients who were on Metformin and Glimepiride.

Methods: Adults patients with diabetic dyslipidaemia fulfilling the inclusion criteria were randomized in two groups. Group A patients received metformin (1000 mg/ day) + Glimepiride (4 mg/day) with fenofibrate (160 mg/day), while group B patients received metformin (1000 mg/day) + Glimepiride (4 mg/day) with saroglitazar (4 mg/day). Glycosylated haemoglobin (HbA1C), triglyceride (TG), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C) levels were measured at baseline and at 12 weeks. Fasting plasma glucose (FPG) and post prandial plasma glucose (PPPG) were measured at baseline and at 4, 8 and 12 weeks.

Results: There was a significant reduction in TG and HbA1C levels at 12 weeks from the baseline value (p=0.001) in both groups. However, there was no significant reduction in TG between the groups at 12 weeks but HbA1C levels in group B decreased significantly compared to group A at 12 weeks. Also, there was a significant reduction in FPG and PPPG levels at 4, 8 and 12 weeks in both groups from their baseline values (p=0.001). The reduction in FPG and PPPG levels in group B was statistically significantly compared to group A at every interval. There was statistically significant change in LDL-C and HDL-C at 12 weeks from baseline in both the groups. Also, there was significant rise in HDL-C in group B when compared to group A.

Conclusions: Group B patients on saroglitazar with metformin and Glimepiride showed a significant reduction in HbA1C, FPG and PPG levels compared to group A patients on fenofibrate with metformin and Glimepiride.


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How to Cite

Ahmed, S. M., & Mujeeb, M. M. A. (2017). A randomized comparative study of efficacy and safety of saroglitazar with fenofibrate in diabetic dyslipidemic patients on metformin and glimeperide. International Journal of Basic & Clinical Pharmacology, 6(6), 1491–1496. https://doi.org/10.18203/2319-2003.ijbcp20172248



Original Research Articles