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Effect Of saroglitazar in patients with type 2 diabetes mellitus

To study the effect Of saroglitazar on insulin sensitivity in patients with type 2 diabetes mellitus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010306
Enrollment
30
Registered
2017-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus

Interventions

Intervention1: Saroglitazar: 4 mg, orally, once a day for 4 months Control Intervention1: Placebo: Identical placebo

Sponsors

Department of Endocrinology
Lead Sponsor

Eligibility

Inclusion criteria

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 4. GAD antibody negative status 5. HbA1c 7.0-9.0% 6. Serum triglyceride > 150mg/dL 7. BMI â?? 23-30 Kg/m2

Exclusion criteria

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 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 ( 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

Design outcomes

Primary

MeasureTime frame
To assess the change in insulin sensitivity by hyperinsulinemic-euglycemic clamp in patients with T2DM and hypertriglyceridemia with saroglitazar as compared to placeboTimepoint: 4 months—

Secondary

MeasureTime frame
To assess the change in body weightTimepoint: 4 months;To assess the change in fasting and post-prandial blood glucose and HbA1cTimepoint: 4 months;To assess the change in fasting C peptideTimepoint: 4 months;To assess the change in fasting insulinTimepoint: 4 months;To assess the change in fasting lipids profileTimepoint: 4 months—

Countries

India

Contacts

Public ContactAshu Rastogi

PGIMER,Chandigarh

nimishadr@gmail.com9811724666

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026