Saroglitazar (LipaglynTM) on Postprandial Lipemia in Type 2 Diabetes Mellitus (PRESS XIII)
- Conditions
- Health Condition 1: null- Type 2 diabetes MellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2015/06/005845
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 30
1. Subjects age 18- 65 years, of either sex.
2. Documented history of T2DM (at least 2 years) defined by ADA criteria.
3. Fasting plasma glucose <=240 mg/dL (<=13.3 mmol/L) at screening.
4. HbA1c should be >=6.5% and <=8.5%, inclusive, at screening.
5. Patients should be on stable doses of metformin for at least 3 months.
6. Body mass index (BMI) >25 to 45 kg/m2, inclusive at screening.
7. Triglyceride level should be >150 and <300 mg/dL at screening.
8. HDL should be <50 mg/dL in female and <40 mg/dL in male.
9. Creatinine clearance >60 mL/min.
10. Subject having normal TSH at screening.
11. If female and of childbearing potential, she shall have a negative serum pregnancy test at the time of screening and agrees to use contraceptive during the study period.
12. Subject must be willing to give written inform consent and able to adhere to dosing and study procedure.
1. Type 1 diabetes mellitus or secondary forms of diabetes.
2. Subjects who have been treated with insulin for >=7 days within 3 months prior to the screening visit.
3. History of acute or chronic metabolic acidosis, including diabetic ketoacidosis.
4. History of bladder cancer or patients with active bladder cancer.
5. Subject with primary dyslipidemia.
6. Subjects with unstable or rapidly progressive diabetic retinopathy, nephropathy (eGFR 60mL/min/1.73m2).
7. Subjects with cardiac insufficiency (e.g., a myocardial infarction (MI), a coronary angioplasty or bypass graft, unstable angina, transient ischemic attacks, or a documented cerebrovascular accident or stroke within 6 months prior to the screening visit).
8. Subjects with cardiac failure or history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4).
9. Uncontrolled hypertension (blood pressure (BP)160/100 mmHg) at the time of screening or last 3 months.
10. Subjects with a serum ALT level >=2.5 times the upper limit of normal (ULN), active liver disease, or jaundice.
11. Subjects taking concomitant anti-lipid medication or other strong cytochrome P450 (CYP)2C8 inhibitors.
12. Subjects on glitazone / glitazar therapy in the past 3 months.
13. Subject with steroids, hormone replacement therapies.
14. History of clinically significant peripheral edema in past 3 months.
15. History of uncontrolled thyroid disorder (abnormal TSH value) and not controlled by thyroid modulating drugs.
16. Subjects with uninvestigated microscopic hematuria.
17. Subjects with any other condition judged by the Investigator as unsuitable for the study.
18. Subjects who have used any investigational or experimental drugs or devices within 60 days of the screening visit.
19. Lactating/Nursing or pregnant female. A positive serum pregnancy test before the first administration of investigational medicinal product or breastfeeding.
20. Male/Female patients planning to participate in a conception process (i.e. active attempt to become pregnant or to impregnate) during clinical trial
21. Prior to the start of the clinical trial the patient participated in the active treatment phase of another clinical trial where a persisting pharmacodynamic effect of the IMP of that clinical trial cannot be excluded (e.g., patient is well into a treatment-free follow-up phase).
22. Patients are considered unable or unwilling to co-operate adequately, i.e., to follow clinical trial procedures and Investigator instructions adequately (e.g., language difficulties, etc.) or patients are anticipated not to be available for scheduled clinical trial visits/procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of the Area Under the Curve (AUC) of plasma triglyceride level during postprandial periodTimepoint: Time points:-0 hr,1 hr, 2 hr, 3hr, 4hr, 06 hr and 08 hr.
- Secondary Outcome Measures
Name Time Method 1Measurement of the AUC of apo B48 and B100 concentration,2Change from baseline(TG,TC,HDL,VLDL,LDL)3Change from baseline in fasting plasma glucose (FPG 4 Measurement of the AUC of plasma triglyceride level during postprandial period.5 hange in glycosylated hemoglobin (HbA1c ).Timepoint: 1Time point: 0 hour and 8 hour) [Time frame: Week 6, Week 12],2 Week 06 and week 12.3 Week 6, Week 12,4 Time: 0, 1, 2, 3, 4, 6, 8 hours) [Time frame: Weeks 6.5 Time frame: Week 12