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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 16000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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