EUCTR2008-005030-73-IT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
GlaxoSmithKline Research and Development0 个研究点目标入组 16,000 人开始时间: 2009年12月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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 ≥ 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 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 e) Waist to hip ratio > 1.0 for men and > 0.8 for women
- •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
研究者
相似试验
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-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-DEGlaxoSmithKline16,000
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
进行中（未招募）
1 期
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: 9.1 Level: PT Classification code 10012601 Term: Diabetes mellitusEUCTR2008-005030-73-FIGlaxoSmithKline
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 - TIDEEUCTR2008-005030-73-SEGlaxoSmithKline16,000