None listed
Conditions
Interventions
Treatment comprised the addition of once daily TZD or placebo, and vitamin D or placebo to the care of participants with T2DM and other CV risk factors for up to 5.5 years for TZDs and for up to 10 ye
Sponsors
GlaxoSmithKline Inc.,
Eligibility
Age
50 Years to 90 Years
Inclusion criteria
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
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 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
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed