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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

Phase 4
50 Years
Not Enrolling
Diabetes Mellitus, Type 2

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Trial Information

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

Inclusion Criteria:

- 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

- Hemoglobin A1c (A1C) 6.5-9.5% inclusive (for assays with upper limit of normal of 6%)
within one month of screening

- Age ≥ 50 years and evidence of vascular disease defined as ≥1of:

- prior myocardial infarction

- prior stroke

- coronary, carotid or peripheral artery revascularization ≥ 4 years earlier

- 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

- Age ≥ 55 years and evidence of subclinical vascular disease defined as ≥1 of:

- microalbuminuria or proteinuria

- history of treated or untreated hypertension with left ventricular hypertrophy
by electrocardiogram (ECG) or echocardiogram

- 50% stenosis on any imaging of coronary, carotid or lower extremity

- ankle/brachial index <0.9 OR

- Age ≥ 60 years and at least 2 of the following cardiovascular disease risk factors:

- current tobacco use

- LDL-c ≥3.4 mmol/L (130 mg/dL) or on a lipid lowering medication

- 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)

- BP lowering medication use or untreated SBP ≥ 140 mmHg or DBP ≥ 95 mmHg

- Waist to hip ratio > 1.0 for men and > 0.8 for women

- On no insulin and on less than or equal to 2 anti-diabetes drugs 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

Exclusion Criteria:

- Type 1 diabetes

- Current need for insulin treatment

- Symptomatic hyperglycemia requiring immediate therapy in the judgment of the

- An acute cardiovascular event within 30 days prior to randomization

- 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

- Any fracture within the past 1 year

- Currently planned coronary, carotid or peripheral artery revascularization or cardiac
valve surgery

- 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

- End stage renal disease requiring renal replacement therapy

- Receiving drug therapy to treat liver disease

- 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)

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 2.5 times
the upper limit of normal

- A prior heart transplant or awaiting a heart transplant

- Previous or current hypercalcemia, hyperparathyroidism, osteomalacia or other
contraindication for vitamin D therapy

- Regular use of or indication for greater than 400IU of vitamin D daily

- Clinically or medically unstable with expected survival < 1 year

- Unwillingness to permit sites to contact their primary physicians to communicate
information about the study and the participant's data

- Any other factor likely to limit protocol compliance or reporting of adverse events

- Inability to discontinue a TZD (if taking one) in the judgement of the

- Contraindications to or history of hypersensitivity to the investigational products

- History of renal stones within the past 2 years

- Participation in another clinical trial of an investigational agent

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD)

Outcome Description:

An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function[s] due to disturbance in the blood supply to the brain not leading to death).

Outcome Time Frame:

From Randomization at Visit 3 up to the Final Visit (average of 162 days)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

October 2015

Related Keywords:

  • Diabetes Mellitus, Type 2
  • Academic Research Collaborator: Population Health Research Institute / Hamilton Health Sciences / McMaster University / Ontario Canada
  • Cardiovascular Outcomes
  • Cardiovascular Diseases
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2