CTRI/2015/06/005845招募中4 期
Evaluate the Effect of Saroglitazar on Postprandial Lipemia in Type 2 Diabetes Mellitus (PRESS XIII) - SARO.14.004.01. PROT
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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