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
Phase 4
Completed
- Conditions
- Health Condition 1: null- Indian patients with type 2 diabetes mellitus and predominant hypertriglyceridemiaHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2014/10/005131
- Lead Sponsor
- Dr Pranab Kumar Sahana
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
Inclusion Criteria
1.Newly diagnosed cases of type 2 diabetes mellitus with predominant hypertriglyceridemia
2.Plasma triglyceride level >= 150 mg/dl
3.HbA1C >= 6.5 & <= 8
Exclusion Criteria
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 TGTimepoint: At week 12 visit
- Secondary Outcome Measures
Name Time Method Change in TC, HDL, LDL, HbA1C, FPG & PPPGTimepoint: At week 12