Safety and efficacy of TRC150094 in reduction of risk for developing heart and metabolism relateddisorders in overweight/obese diabetic subjects with abnormal lipid profile.
Phase 2
Completed
- Conditions
- Health Condition 1: null- Overweight/Obese, Diabetic subjects with dyslipidemia
- Registration Number
- CTRI/2013/03/003444
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 225
Inclusion Criteria
Male and female subjects in the age range 30 year to 65 (Both inclusive)years
Waist circumference in men >=90 cm and women >=80 cm
BMI in the range 23-35 (inclusive) kg/m2
Fasting glucose >=126 mg/dL or HbA1C>=6.4 or stabilized on treatment with <=2 oral hypoglycemic agents other than alpha glucosidase inhibitors
ApoB >= 100mg/dL
Triglyceride >=150mg/dL
Blood pressure SBP >=130 mmHg and DBP >=85 mmHg with or without anti-hypertensive treatment
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoints <br/ ><br> Apo B <br/ ><br> Ambulatory BP <br/ ><br> Fasting Insulin and Fasting Glucose <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Baseline, Week 12 and Week 24 <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method <br/ ><br> TG clearance after a standardized fat load <br/ ><br> Non-HDL Cholesterol and Apo B Apo A1 ratio <br/ ><br> Hepatic and Visceral Fat in sub set <br/ ><br>Timepoint: TG clearance after a standardized fat load at Baseline and Week 24 <br/ ><br>Non-HDL Cholesterol and Apo B Apo A1 ratio at Baseline Week 12 and Week 24 <br/ ><br>Hepatic and Visceral Fat in sub set at Baseline and Week 24 <br/ ><br> <br/ ><br>