Effect Of saroglitazar in patients with type 2 diabetes mellitus

Not Applicable

• Conditions: Health Condition 1: null- Type 2 Diabetes Mellitus

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 â?? 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