PER-005-10已完成未知
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.
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- 50 至 90（—）
入选标准
- •1.Men or women with: a) newly detected type 2 diabetes based on a fasting plasma glucose greater than or equal to 7.0 mmol/l (126 mg/dL) or a 2 hour plasma glucose (FPG) greater than or equal to 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.Age ≥ 50 years and evidence of vascular disease defined as ≥1of: a) prior myocardial infarction b)prior stroke
- •coronary, carotid or peripheral artery c)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 OR
- •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 OR
- •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
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 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
研究者
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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.10012653Type 2 DiabetesNL-OMON35554GlaxoSmithKline525
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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 - TIDEPatients with type 2 diabetes at risk for cardiovascular diseases.MedDRA version: 12.1Level: LLTClassification code 10012601Term: Diabetes mellitusEUCTR2008-005030-73-ITGlaxoSmithKline Research and Development16,000
进行中（未招募）
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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- Incidence of CV outcomes compared to placebo for the TZD class as a whole, rosiglitazone (RSG), and pioglitazone (PIO) when added to the therapeutic regimen of a person with type 2 diabetes who has additional risk factors for CV events. - Determine whether adding vitamin D in such individuals is superior to adding placebo with respect to reducing the incidence of death or serious cancers requiring hospitalization, chemotherapy or surgery compared to placebo.MedDRA version: 9.1Level: PTClassification code 10012601Term: Diabetes mellitusEUCTR2008-005030-73-DKGlaxoSmithKline16,000
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- Incidence of CV outcomes compared to placebo for the TZD class as a whole, rosiglitazone (RSG), and pioglitazone (PIO) when added to the therapeutic regimen of a person with type 2 diabetes who has additional risk factors for CV events. - Determine whether adding vitamin D in such individuals is superior to adding placebo with respect to reducing the incidence of death or serious cancers requiring hospitalization, chemotherapy or surgery compared to placebo.MedDRA version: 9.1Level: PTClassification code 10012601Term: Diabetes mellitusEUCTR2008-005030-73-CZGlaxoSmithKline16,000