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Effect of saroglitazar on vascular function in patients with type 2 diabetes

"Efficacy and safety of saroglitazar on vascular function in patients with type 2 diabetes mellitus: A randomized, double blind, parallel arm, placebo controlled trial" - STARDDOM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025946
Enrollment
140
Registered
2020-06-17
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: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Saroglitazar: Oral Saroglitazar 4 mg once daily for 3 months with standard background therapy (Metformin with or without sulfonylureas) Control Intervention1: Placebo: Oral similar look

Sponsors

JIPMER Intramural Research Grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus diagnosed by American Diabetes Association (ADA) criteria within the past 3 months to 10 years, on stable dose of metformin with or without sulfonylureas, for at least past 2 months, with HbA1C of 7.5-9%

Exclusion criteria

Exclusion criteria: 1) Liver dysfunction (AST,ALT > 2 times the upper limit of normal) 2) Renal dysfunction (GFR 3) Patient with concurrent illnesses like CAD(Coronary Artery Disease), CVA( cerebrovascular accidents), PVD(Peripheral Vascular Disease), CKD( Chronic Kidney Disease)other than hypertension 4) Patients taking anti diabetic drugs other than metformin and sulfonylureas 5) Pregnant women or lactating mothers; women in reproductive age group not practicing contraceptive measures. 6) Patients who had participated in other trials in the past three months. 7) Patients with active infections such as diabetic foot infection etc

Design outcomes

Primary

MeasureTime frame
Carotid femoral pulse wave velocityTimepoint: Carotid femoral pulse wave velocity at baseline, 1st, 2nd, and 3rd months—

Secondary

MeasureTime frame
1. s-ICAM, S-VCAM, E-selectin, interleukin-6 2.Lipid profile 3. Adverse drug reactions to saroglitazarTimepoint: 1. s-ICAM, S-VCAM, E-selectin, interleukin-6 at baseline and 3 months 2.Lipid profile at baseline and 3 months 3. Adverse drug reactions to saroglitazar at baseline, 1st, 2nd, 3rd months—

Countries

India

Contacts

Public ContactDr Sadishkumar Kamalanathan C

JIPMER

sandhiyaselvarajan@gmail.com9443492922

Outcome results

None listed

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