Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Tab Saroglitazar 4 mg
: Patients will receive Saroglitazar 4 mg daily orally for 6 months
Control Intervention1: Standard of care ( Statin therapy): Patient will receive standard of ca
Sponsors
ARINDAM NASKAR
Eligibility
Inclusion criteria
Inclusion criteria: Adult subjects (more than 18 years to less than 65 of age) of any gender Established diagnosis of type 2 diabetes mellitus Serum fasting triglyceride more than 150mg/dl On Statin therapy for at least 6 month Willing to providing written informed consent
Exclusion criteria
Exclusion criteria: Type 1 diabetes Pregnancy or breastfeeding lady Triglyceride level more than 500 mg/dL Any concomitant thyroid disorders Patients having estimated GFR less than 45 ml/min/1.73m2 Patients known Heart failure (Stage III or IV) Severe liver dysfunction(Child Pugh C) Baseline AST, ALT more than 3 times of upper limit Hemoglobin less than 8 gm/dL Tobacco abusers, Alcoholic and any kind of substance abusers Patients with malignancy and/or on chemotherapy Patients with infectious disease like HIV, Hepatitis B, Hepatitis C On other Triglyceride lowering therapy ( Fenofibrate, Icosapent Ethyl) Patients on oral contraceptive pills, antipsychotic drugs Patients taking steroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Saroglitazar vs standard of care on arterial stiffness in patients of T2DM and hyper tryglyceridemia ( TG more than 150mg/dL) from baseline to week 24Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare any changes from baseline to week 24 in 1. Lipid Profile 2. HbA1C,FBS,PPBS 3. BMI 4. eGFR 5. Urinary albumin creatinine ratio 6. ALT and ASTTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Arindam Naskar
School of Tropical Medicine
Outcome results
None listed