Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Saroglitazar: atorvastatin 10mg with saroglitazar 4 mg once daily for 3 months
Control Intervention1: Fenofibrate: atorvastatin 10mg with fenofibrate 200mg once daily for 3 months
Sponsors
Maulana azad medical college
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed patients of diabetic dyslipidemia with (fasting TG > 200 to 400 mg/dL) 2. Patients in the age group of 18 to 65 years, 3.Patients with history of type 2 diabetes mellitus (glycosylated hemoglobin [HbA1c] >7% to 9%), 4.Patients being treated with either a sulphonylurea, metformin for diabetes, or both treatments for at least 3 months. 5.Patients being treated with Atorvastatin 10mg tablet for at least 4 weeks.
Exclusion criteria
Exclusion criteria: 1.Patients on insulin, glitazone or glitazar, or medications with a lipid-lowering agent in past 2 weeks. 2.Patients who had a history of cardiac abnormalities (myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty,unstable angina or heart failure, hypertension ( >150/100 mmHg). 3. Patients with thyroid dysfunction. 4. Patients having hepatic dysfunction (aspartate aminotransferase/alanine aminotransferase �2.5 times of upper normal limit [UNL] or bilirubin > 2 times of UNL). 5. Patients with renal dysfunction (serum creatinine >1.2 mg/dL). 6. Patients with Comorbid serious illness such as tuberculosis, HIV, Malignancy. 7. Patients on Alcohol or drug abuse. 8. Patients allergic to the study medications 9. Pregnant female patients and nursing mothers were also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute changes in serum triglyceride level at baseline and at end of treatment period.Timepoint: At baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline lipids HDL-C (high density lipoprotein-cholesterol), LDL-C(low density lipoprotein-cholesterol), Total Cholesterol, VLDL-C(very low density lipoprotein-cholesterol), FBG and HbA1c profile at the end of treatment period. 2. Safety assessment during the duration of therapy.Timepoint: At baseline and at 12 weeks | — |
Countries
India
Contacts
Public ContactDr Rahul Gahalot
Maulana azad medical college and Lok Nayak Hospital
Outcome results
None listed