NL-OMON35554已完成3 期
Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE). A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione (TZD) or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease. - TIDE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 525
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Men or women with: a) newly detected type 2 diabetes based on a fasting plasma glucose >= 7.0 mmol/l (126 mg/dL) or a 2 hour plasma glucose (FPG) >= 11.1 mmol/l (200 mg/dL) on an oral glucose tolerance test, or b) a history of type 2 diabetes
- •2. Hemoglobin A1c (A1C) 6.5-9.5% inclusive (for assays with upper limit of normal of
- •6%) within one month of screening
- •3. A) Age >= 50 years and evidence of vascular disease defined as >=1of:
- •a) prior myocardial infarction
- •b) prior stroke
- •c) coronary, carotid or peripheral artery revascularization >= 4 years earlier
- •d) previous documented myocardial ischemia on either an exercise stress test or
- •on any cardiac imaging, or previous unstable angina with ECG changes or
- •cardiac enzyme elevation
- •B) Age >= 55 years and evidence of subclinical vascular disease defined as >=1 of:
- •a) microalbuminuria or proteinuria
- •b) history of treated or untreated hypertension with left ventricular hypertrophy
- •by electrocardiogram (ECG) or echocardiogram
- •c) >50% stenosis on any imaging of coronary, carotid or lower extremity arteries
- •d) ankle/brachial index <0.9
- •C) Age >= 60 years and at least 2 of the following cardiovascular disease risk factors:
- •a) current tobacco use
- •b) LDL-c >=3.4 mmol/L (130 mg/dL) or on a lipid lowering medication
- •c) HDL-c < 1.0 mmol/L (40 mg/dL) for men and < 1.3 mmol/L (50 mg/dL) for women or triglycerides >= 2.3 mmol/L (200 mg/dL)
- •d) BP lowering medication use or untreated SBP >= 140 mmHg or DBP >= 95 mmHg
- •e) Waist to hip ratio > 1.0 for men and > 0.8 for women
- •4. On no insulin and on <= 2 anti-diabetes drugs where at least one drug is at or below the half-maximal dose (as indicated in the MOP) with stable dosing for 10 weeks prior to screening
- •5. A negative pregnancy test for all females of childbearing potential (i.e., ovulating,
- •pre-menopausal, and not surgically sterile) and agreement to use adequate birth
- •control (according to local regulations) throughout the study
- •6. Adherence >= 80% and tolerability to single-blind study medication during the run-in phase
- •7. Provision of signed and dated informed consent prior to any study procedures
排除标准
- •1. Type 1 diabetes
- •2. Current need for insulin treatment
- •3. Symptomatic hyperglycemia requiring immediate therapy in the judgment of the
- •4. An acute cardiovascular event within 30 days prior to randomization
- •5. Symptomatic heart failure (i.e. New York Heart Association class II or higher) or any episode of previous pulmonary edema or known ejection fraction < 0.4 or current use of loop diuretics
- •6. Any fracture within the past 1 year
- •7. Currently planned coronary, carotid or peripheral artery revascularization or cardiac valve surgery
- •8. Coronary, carotid or peripheral artery revascularization within the 4 years prior to
- •screening in the absence of angina, MI, or stroke in the intervening period
- •9. End stage renal disease requiring renal replacement therapy
- •10. Receiving drug therapy to treat liver disease
- •11. A diagnosis of cancer (other than superficial squamous, basal cell skin cancer, or
- •adequately treated cervical carcinoma in situ) in the past 3 years or current treatment for the active cancer (other than prophylactic)
- •12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 2.5
- •times the upper limit of normal
- •13. A prior heart transplant or awaiting a heart transplant
- •14. Previous or current hypercalcemia, hyperparathyroidism, osteomalacia or other
- •contraindication for vitamin D therapy
- •15. Regular use of or indication for greater than 400IU of vitamin D daily
- •16. Clinically or medically unstable with expected survival < 1 year
- •17. Unwillingness to permit sites to contact their primary physicians to communicate
- •information about the study and the participant*s data
- •18. Any other factor likely to limit protocol compliance or reporting of adverse events
- •19. Inability to discontinue a TZD (if taking one) in the judgement of the
- •physician/investigator
- •20. Contraindications to or history of hypersensitivity to the investigational products
- •21. History of renal stones within the past 2 years
- •22. Participation in another clinical trial of an investigational agent
- •23. Previous randomization in this study
研究者
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