Study of Saroglitazar in Type 2 Diabetis Mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/04/032550
- Lead Sponsor
- AIIMS Jodhpur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Age 18 â?? 65yr.
2.Diagnosis of type 2 diabetes mellitus as per ADA criteria.
3.On lifestyle modifications and on metformin; vildagliptin medications for 3 months.
4.HbA1C >7%
1.Patient who had any clinically significant or unstable medical or Psychiatric illness.
2.History of cardiac diseases (NYHA grade 3 â?? 4) or cardiac anomalies.
3.Patient on glitazone/glitazar for >30days.
4.History of Renal insufficiency - serum creatinine >=1.8mg/dl.
5.Patient with history of significant hepatic impairment (serum bilirubin >2 times, AST, ALT and alkaline phosphatase >3 times the upper limit of normal).
6.Patient have history of uncontrolled hypertension.
7.Patient have any malignancy and Patient have any h/o substance abuse (alcohol/drugs).
8.Pregnant & Lactating Woman and Patient with history of allergy/intolerance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of Saroglitazar versus placebo in terms of HbA1c values in T2DM.Timepoint: Throughout the study
- Secondary Outcome Measures
Name Time Method 1.To evaluate the effect on lipid profile parameters of Saroglitazar versus placebo in T2DM. <br/ ><br>2.To evaluate the effect on HOMA index of Saroglitazar versus placebo in T2DM. <br/ ><br>3.To evaluate the effect on Metabolic syndrome parameters of Saroglitazar versus placebo in T2DM. <br/ ><br>4.To evaluate the effect on QOL score of Saroglitazar versus placebo in T2DM. <br/ ><br>5.To evaluate the safety of Saroglitazar versus placebo in T2DM. <br/ ><br>Timepoint: Throughout the study