Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Saroglitazar 4 mg OD and matching placebo: 4 mg OD saroglitazar for 12 weeks
Control: Matching placebo for 12 weeks
Control Intervention1: Placebo: Matching placebo for 12 weeks
Sponsors
JIPMER Intramural fund
Eligibility
Inclusion criteria
Inclusion criteria: 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%
Exclusion criteria
Exclusion criteria: • Liver dysfunction (AST, ALT > 2 times the upper limit of normal) • Renal dysfunction (GFR • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • 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. • 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. • 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. • 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 Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Sadishkumar Kamalanathan
JIPMER
Outcome results
None listed