Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE)

Not Applicable

• Registration Number: PER-005-10
• Lead Sponsor: GlaxoSmithKline Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified