Effect of saroglitazar in patients with diabetes mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/09/057322
- Lead Sponsor
- JIPMER Intramural fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients with type 2 diabetes mellitus diag-nosed 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% - 8%
•Liver dysfunction (AST, ALT > 2 times the upper limit of normal)
•Renal dysfunction (GFR <60 ml/min/1.73 m2)
•Patient with concurrent illnesses like CAD (Coronary Artery Disease), CVA ( cerebro-vascular accidents), PVD(Peripheral Vascular Disease), CKD (Chronic Kidney Disease) other than hypertension
•Patients taking anti diabetic drugs other than metformin and sulfonylureas
•Pregnant women or lactating mothers; women in reproductive age group not practicing contraceptive measures.
•Patients who had participated in other trials in the past three months.
•Patients with active infections such as diabet-ic foot infection, etc
•Patients not willing / able to perform bicycle ergometer.
•Patients with Asthma, COPD, active tubercu-losis and history of acute respiratory infection in the last 1 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the add-on effect of saroglitazar on HbA1c in patients with type 2 diabetes mellitus as compared to placebo at the end of 12 weeks.Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method •To evaluate the add-on effect of saroglitazar on fasting & post-prandial glucose levels in patients with type 2 diabetes mellitus as compared to placebo at the end of 12 weeks. <br/ ><br>•To evaluate the add-on effect of saroglitazar on vascular functions (carotid femoral Pulse Wave Velocity, brachial ankle pulse wave velocity, right & left brachial arterial stiffness index, right & left arterial stiffness index, ankle brachial index, aortic systolic/diastolic pressure, aortic augmenta-tion pressure & aortic augmentation index) as compared to placebo at the end of 12 weeks. <br/ ><br>•To evaluate the add-on effect of saroglitazar on insulin resistance and insulin sensitivity (HOMA-IR, QUICKI) as compared to placebo at the end of 12 weeks. <br/ ><br>•To evaluate the add-on effect of saroglitazar on exercise capacity in patients with type 2 diabetes mellitus as compared to placebo at the end of 12 weeks <br/ ><br>Timepoint: 12 weeks