Health Condition 1: null- Dyslipidemia Health Condition 2: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Fenofibrate: Route-Oral Frequency -Once daily Duration -06 Months Dosage :-Fenofibrate 160 Mg
Control Intervention1: Saroglitazar 2 Mg and 4 Mg: Route-Oral
Frequency -Once daily
Durati
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects age 18- 65 years, of either sex 2. Subjects with hypertriglyceridemia (>=200 mg/dL) at the time of screening and after life style modifications for 6 weeks 3. Both diabetic (type 2 diabetes mellitus; should be HbA1c 4. Body mass index (BMI) > 18.5 kg/m2 5. Subject has given informed consent for participation in this trial.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and lactation 2. History of 5% weight loss in past 6 months 3. Subject with diabetes mellitus with HbA1C >=9% 4. Subject with type 1 diabetes 5. Subjects on glitazone / glitazar therapy in the past 3 month. 6. Subject of nutraceuticals within last 3 months 7. Diabetic Ketoacidosis/Hyperosmolar coma 8. Subjects having unstable angina, Acute Myocardial Infarction in past 3 months or heart failure of NYHA class (III-IV) 9. Uncontrolled hypertension (BP160/100 mmHg) 10. History of clinically significant peripheral edema in past 3 months 11. History of uncontrolled thyroid disorder (abnormal TSH value) and not controlled by thyroid modulating drugs 12. History of active liver disease or gall stones or hepatic dysfunction demonstrated by AST and ALT >=2.5 times of upper normal limit (UNL) or bilirubin >=2 times UNL 13. Renal dysfunction demonstrated by serum creatinine 1.5 mg/dL or eGFRÂ Â 60Â mL/min/1.73Â m2. 14. History of myopathies or evidence of active muscle diseases demonstrated by CPK >=10 times UNL at screening visit 15. History of Pancreatitis in last 3 months 16. Any other concurrent serious illness within past 5 years (e.g. tuberculosis, HIV, malignancy) 17. History of alcohol and/or drug abuse 18. History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients 19. Subjects on concomitant medications known to affect the lipid level (Appendix 3) other than statins in past 4 weeks (with TG>=200) 20. History of contraceptive, hormone replacement therapy (HRT) or steroids since last 3 months 21. Participation in any other clinical trial in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the percentage change in triglyceride (TG) levels in 2 and 4 mg of Saroglitazar as compared to fenofibrateTimepoint: 6 weeks, 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the percentage change in lipid parameters (Time frame: 12 and 24 weeks) a. LDL b. VLDL c. HDL d. Total cholesterol e. Non HDL cholesterol f. Apo A1 g. Apo B.Timepoint: 12 weeks and 24 weeks.;To compare the percentage change in triglyceride (TG) levels in 2 and 4 mg of Saroglitazar as compared to fenofibrate 160 mg at Week 6.Timepoint: Week 06 | — |
Countries
India
Contacts
Public ContactDr Deven Parmar
Cadila Healthcare Limited
Outcome results
None listed