Status:
TERMINATED
Thiazolidinedione Intervention With Vitamin D Evaluation
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Population Health Research Institute
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
1332 Patients enrolled
Trial Details
Trial ID
NCT00879970
Start Date
May 1 2009
End Date
November 1 2010
Last Update
April 18 2017
Active Locations (331)
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1
GSK Investigational Site
Long Beach, California, United States, 90822
2
GSK Investigational Site
Los Angeles, California, United States, 90033
3
GSK Investigational Site
Northridge, California, United States, 91324
4
GSK Investigational Site
San Diego, California, United States, 92109