EUCTR2008-005030-73-GR进行中（未招募）不适用
Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease - TIDE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men or women with:
- •a) newly detected type 2 diabetes based on a fasting plasma glucose higher than 7.0 mmol/l (126 mg/dL) or a 2 hour plasma glucose higher than 11.1 mmol/l (200 mg/dL) on an oral glucose tolerance test, or b) a history of type 2 diabetes
- •2. A1C 6.5-9.5% inclusive
- •3. A) Age = 50 years and evidence of vascular disease(at least 1):
- •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 (at least 1):
- •a) microalbuminuria or proteinuria
- •b) history of treated or untreated hypertension with left ventricular hypertrophy by 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 CVD risk factors:
- •a) current tobacco use
- •b) LDL-C =3.4 mmol/L (130 mg/dL)
- •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 less or equal than 2 anti-diabetes drugs (OAD) 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 physician
- •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 of 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 indication or contraindication for vitamin D therapy
- •15. Clinically or medically unstable with expected survival < 1 year
- •16. Unwillingness to permit sites to contact their primary physicians to communicate information about the study and the participant’s data
- •17. Any other factor likely to limit protocol compliance or reporting of adverse events
- •18. Inability to discontinue a TZD (if taking one) in the judgement of the physician/investigator
- •19. Contraindications to or history of hypersensitivity to the investigational products
- •20. History of renal stones within the past 2 years
- •21. Participation in another clinical trial of an investigational agent
- •22. Previous randomization in this study
- •French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
研究者
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