Category: Diabetes/Prediabetes/Hypoglycemia

Monitor: 22

22 - SAROGLITAZAR IMPROVES INSULIN SENSITIVITY IN PATIENTS OF TYPE 2 DIABETES MELLITUS WITH HYPERTRIGYCERIDEMIA- A PILOT STUDY

Saturday, Apr 27
11:30 AM – 12:00 PM

Objective : Saroglitazar, a dual PPAR-α/γ agonist, is approved for the treatment of diabetic dyslipidemia in India. However, its effects on glycemic control and insulin sensitivity remain elusive. We aimed to assess the effect of saroglitazar on insulin sensitivity in patients of type 2 diabetes mellitus with hypertriglyceridemia in a pilot study.


Methods :

Randomised, double blinded, placebo controlled trial (CTRI/2017/10/010306). Treatment naive patients with T2DM between 30 and 60 years of age with serum triglyceride > 150 mg/dL and duration of diabetes < 5 years were included. Patients were randomized to receive either saroglitazar 4mg or placebo (1:1) along with lifestyle modification, for 4 months. Glimepiride was allowed as rescue therapy. Patients underwent hyperinsulinemic euglycemic clamp at baseline and at the end of 4 months. Glucose metabolism (M), clamp insulin sensitivity (M/I), HOMA- β, HOMA-IR, log HOMA, 1/HOMA and QUICKI were calculated at baseline and at the end of study. Student T-tests (paired and unpaired), Mann Whitney U, Wilcoxon signed rank test and analysis of covariance (ANCOVA) were used as appropriate.


Results : 15 patients each were randomised to receive saroglitazar and placebo, respectively. Mean age 44±9.5 years. The groups were matched for most parameters, however, saroglitazar arm had significantly higher serum triglycerides (TG) (p = 0.032),  lower high density lipoprotein (HDL-C) levels (p= 0.026) and lower HOMA-β values (p=0.045) at baseline. Median glimepiride dose was same in both groups. 5 patients did not complete the study (3 placebo, 2 saroglitazar). On intention to treat analysis, patients on saroglitazar had a greater improvement in M/I (p=0.026), HbA1c (p=0.019) and fasting blood glucose (p=0.019) as compared to placebo. The effect of saroglitazar on M/I persisted despite controlling for anthropometric parameters, lipid profile and HbA1c (partial η2=0.192, p=0.047). Saroglitazar also resulted in higher fall in TG levels (p=0.003), significant increase in HDL-C levels (p<0.01) and higher rise in HOMA- β (p=0.037) as compared to placebo even after correcting for baseline values. Other parameters did not differ significantly between the two groups. No adverse events were noted during the study.


Discussion :

Saroglitazar improved M/I, HbA1c and fasting blood glucose along with expected improvement in lipid profile. Change in M/I, however, did not correlate with change in HbA1c suggesting that the beneficial effects of saroglitazar on M/I were likely independent of its effects on glucotoxicity.


Conclusion : Saroglitazar improves insulin sensitivity in patients with type 2 diabetes mellitus with hypertriglyceridemia.

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Nimisha Jain

Fellow-in-Training
Department of Endocrinology, PGIMER, Chandigarh, Chandigarh, India

Nimisha Jain is currently pursuing her DM Endocrinology at the prestigious PGIMER, Chandigarh, India. She did her undergraduate training as well as postgraduate training in General Medicine from Lady Hardinge Medical College, New Delhi, India. Her areas of interest include diabetes mellitus and bone metabolism.

Shobhit Bhansali

Post doc fellow
Department of Medicine/Endocrinology, Albert Einstein College of Medicine, Bronx, New York

Shobhit Bhansali did his PhD from PGIMER, Chandigarh, India and is currently pursuing research.

Ashu Rastogi

Assistant Professor
Deptt. of Endocrinology, PGIMER, Chandigarh
Chandigarh, Chandigarh, India

Faculty at Deptt. of Endocrinology at PGIMER, Chandigarh. Actively involved in patient care and research in the field of Diabetic Foot Complications

Anil Bhansali

Professor
PGIMER
Chandigarh, Chandigarh, India

Professor of Endocrinology at PGIMER, Chandigarh

Nimisha Jain

Fellow-in-Training
Department of Endocrinology, PGIMER, Chandigarh, Chandigarh, India

Nimisha Jain is currently pursuing her DM Endocrinology at the prestigious PGIMER, Chandigarh, India. She did her undergraduate training as well as postgraduate training in General Medicine from Lady Hardinge Medical College, New Delhi, India. Her areas of interest include diabetes mellitus and bone metabolism.