Effect Of saroglitazar in patients with type 2 diabetes mellitus

Recruiting

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: CTRI/2017/10/010306
• Lead Sponsor: Department of Endocrinology

Brief Summary

India is considered to be the “Diabetes Capital of the World†having 66 million subjects with diabetes and every fifth diabetic being an Indian. The morbidity and mortality in type 2 diabetes is attributed to microvascular and macrovascular complications. A plethora of therapeutic options are available including non pharmacological measures such as medical nutrition therapy (MNT) and exercise as well as pharmacological options such as sulfonylureas, metformin, thiazolidinediones, insulin, etc. It has been reported that insulin sensitisers are associated with reduction of cardiovascular diseases morbidity and mortality. PPAR-alpha agonists are approved for lipid control and PPAR-gamma agonist for achieving glycemic control in type 2 diabetes. Saroglitazar with dual PPAR alpha/gamma agonist activity, and excellent safety profile is being used for  patients having diabetic dyslipidemia, as the drug has shown efficacy in improving both, the lipid due to PPAR-alpha agonistic property and the glycemic parameters , attributable to PPAR-gamma agonistic property. However, the drug is not yet approved for glycemic control in patients with Type 2 Diabetes Mellitus.

Our aim is to assess the effect of saroglitazar on insulin sensitivity in patients of T2DM with hypertriglyceridemia. Our primary objective is to assess the change in insulin sensitivity by hyperinsulinemic-euglycemic clamp in patients with T2DM and hypertriglyceridemia with saroglitazar as compare to placebo. our primary hypothesis is that saroglitazar will cause an improvement in insulin sensitivity owing to its  PPAR-gamma agonistic property.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-25
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Patients with T2DM between 30 and 60 years of age 2.Treatment naïve or on monotherapy with metformin/voglibose 3.Duration of Diabetes < 5 yr 4.GAD antibody negative status 5.HbA1c 7.0-9.0% 6.Serum triglyceride > 150mg/dL 7.BMI – 23-30 Kg/m2.

Exclusion Criteria

1.Type 1 diabetes mellitus or secondary diabetes 2.Past history of DKA or having ketonemia or ketonuria 3.Uncontrolled hypertension 4.Thyroid disorder 5.Renal dysfunction defined by eGFR < 60 ml/min/m2 6.Hepatic dysfunction (AST/ALT > 2.5 ULN, T.Bilirubin > 2 X ULN), myopathies 7.Receiving statins, fibrates, hormone replacement therapies and steroids 8.Seropositivity for HIV, HBV and HCV 9.Recent cardio vascular event (<6 months) 10.History of malignancy 11.Active infection 12.Alcohol ( >14 units/ week or 112 gm pure alcohol for men, > 7 units/week or 56 gm pure alcohol for women) (26) or drug abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the change in insulin sensitivity by hyperinsulinemic-euglycemic clamp in patients with T2DM and hypertriglyceridemia with saroglitazar as compared to placebo	4 months

Secondary Outcome Measures

Name	Time	Method
To assess the change in fasting and post-prandial blood glucose and HbA1c	4 months
To assess the change in body weight	4 months
To assess the change in fasting C peptide	4 months
To assess the change in fasting lipids profile	4 months
To assess the change in fasting insulin	4 months

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Nimisha Jain

Principal investigator

nimishadr@gmail.com