Resumen

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

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

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
% 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

Criterios de exclusión

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

Intervenciones

drug

pioglitazone

Pioglitazone30 mg and 45 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.

drug

rosiglitazone

Rosiglitazone 4 mg and 8 mg tablets are over-encapsulated with Swedish orange size DB-AA capsule shell.

drug

placebo

Placebo to match is Swedish orange size DB-AA capsule filled with white to off-white non-active powder blend.

dietary_supplement

Vitamin D

Vitamin D factor intervention

dietary_supplement

Placebo

Vitamin D factor intervention

Ubicaciones

GSK Investigational Site

Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Coronel Suárez, Buenos Aires, Argentina

GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

GSK Investigational Site

San Nicolás de los Arroyos, Buenos Aires, Argentina

GSK Investigational Site

Salta, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

Zárate, Argentina

AVANDIA CV Outcomes Study: 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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

pioglitazone

rosiglitazone

placebo

Vitamin D

Placebo

Ubicaciones

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Patrocinadores