The study is conducted to compare the effectiveness and safety of saroglitazar and metformin combination therapy to that of fenofibrate and metformin combination therapy in Indian patients with type 2 diabetes mellitus and increased plasma triglyceride level
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2014/10/005131
- Lead Sponsor
- Dr Pranab Kumar Sahana
- Brief Summary
Diabetes have increased cardiovascular risk. The risk is exaggerated by dyslipidemia. Saroglitazar is the first dual PPAR alfa/gamma agonist for patients suffering from diabetic dyslipidemia.
Present study is designed to compare the effectiveness and safety of add on therapy of saroglitazar and fenofibrate with metformin in Indian patients with diabetic dyslipidemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 17
1.Newly diagnosed cases of type 2 diabetes mellitus with predominant hypertriglyceridemia 2.Plasma triglyceride level ≥ 150 mg/dl 3.HbA1C ≥ 6.5 & ≤ 8.
1Female patients who are pregnant or lactating 2.Patients on any oral anti-diabetic drug 3.FPG > 250mg/dl, PPPG > 350mg/dl, LDL-C > 130 mg/dl 4.Co-morbid cardiovascular, renal and psychiatric diseases 5.Co-administration of drugs that are likely to interact with saroglitazar, fenofibrate or metformin and drugs that are likely to alter lipid profile and glycemic status 6.Past history of cardiovascular disease 7.Patients with rising FPG and PPPG levels at week 4 or 8.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in TG At week 12 visit
- Secondary Outcome Measures
Name Time Method Change in TC, HDL, LDL, HbA1C, FPG & PPPG At week 12
Trial Locations
- Locations (1)
Out Patient Department
🇮🇳Kolkata, WEST BENGAL, India
Out Patient Department🇮🇳Kolkata, WEST BENGAL, IndiaDr Arijit GhoshPrincipal investigator919874727137drarijitghosh@gmail.com