Thiazolidinedione Intervention With Vitamin D Evaluation

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This study will answer two separate questions. The first question is to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease. The second question will compare the effects of long-term supplementation of vitamin D on death and cancer

Key facts

Study ID

NCT00879970

Run by

GlaxoSmithKline

People needed

1332

Starts

2009-05-01

Expected to finish

2010-11-01

Last updated by the study team

2017-04-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 arteries
• 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

You may not qualify if…

• Type 1 diabetes
• Current need for insulin treatment
• Symptomatic hyperglycemia requiring immediate therapy in the judgment of the physician
• 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 physician/investigator
• 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

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Northridge, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Decatur, Georgia, United States
• GSK Investigational Site — Tucker, Georgia, United States
• GSK Investigational Site — Pocatella, Idaho, United States
• GSK Investigational Site — Pocatello, Idaho, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Haverhill, Massachusetts, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Kalispell, Montana, United States
• GSK Investigational Site — Westfield, New York, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Kingsport, Tennessee, United States
• GSK Investigational Site — Memphis, Tennessee, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Temple, Texas, United States
• GSK Investigational Site — Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — Long Beach, California, United States

Full record on ClinicalTrials.gov

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