The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.

Elegibilidad

Edad mínima: 30 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Male or female between 30 to 80 years of age, inclusive.
Established diagnosis of T2DM (based on diagnostic criteria of the American Diabetes Association (ADA), WHO guidelines or local national guidelines).
Subjects who are undergoing coronary angiography for evaluation of suspected or previously diagnosed coronary artery disease or who are undergoing PCI.
Subjects' prior anti-hyperglycemic diabetic therapy:
Diet and exercise only (drug naïve), with HbA1c \>7.0 and £ 10.0%. HbA1c \> 6.5 and \<= 8.5%.
Left ventricular ejection fraction (EF) ³ 40% as assessed by contrast ventriculography (or previously documented in medical notes within one month prior to index procedure by other methods e.g. echocardiography or nuclear study)
Female subjects must be postmenopausal (i.e., \>6 months without menstrual period), surgically sterile, or using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD), a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures for at least 1 month prior to visit 1a, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
Willingness and ability to give informed consent prior to entering the study and available to complete the study.

Criterios de exclusión

Type 1 diabetes and/or history of diabetic ketoacidosis.
Exposure to a TZD or other PPAR-g agonist within the 6 months prior to screening visit.
Subjects treated with triple OAD therapy or high dose dual combination OAD therapy \[1\].
Subjects who have required chronic insulin use in the last 6 months (except during pregnancy or acute episodes such as hospitalization, trauma or infection).
ST segment elevation myocardial infarction in the last 30 days.
Subjects who have a history or are scheduled to receive coronary artery bypass graft surgery (CABG), valve repair or replacement, aneurysmectomy or planned major non-cardiac surgery during the study period.
Subjects who have severe cardiac valvular disease
Stroke or resuscitated in the past 6 months
History of congestive heart failure (NYHA class I - IV)
History of significant hypersensitivity or reaction (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to any TZD, SU, biguanide or insulin
Prior history of severe edema or edema requiring medical treatment.
Chronic disease requiring chronic or intermittent treatment with oral, intravenous, or injected corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
Untreated hypo- or hyperthyroidism
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.
Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgement of the Investigator, would preclude safe completion of the study.
Blood pressure: SBP \>170 or DBP \> 100 mmHg
Significant anemia (Hemoglobin \< 11 g/dL for males and \< 10 g/dL for females).
Significant renal disease manifested by serum creatinine (\> 1.5mg/dL for males or \> 1.4mg/dL for females), or where the use of metformin is contra-indicated.
Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 2.5 times upper limit of normal (ULN) or bilirubin \>2x ULN).
History of myopathy or history of elevated creatine kinase (CK) \> 3 times upper normal limit.
Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer).
Women who are lactating, pregnant or planning to become pregnant during the course of the study.
Unwillingness or inability to comply with the procedures described in this protocol.

Ubicaciones

GSK Investigational Site

Capital Federal, Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Munro, Buenos Aires, Argentina

GSK Investigational Site

San Justo, Buenos Aires, Argentina

GSK Investigational Site

San Martín, Buenos Aires, Argentina

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Moron-Provincia de Buenos Aires, Argentina

A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone Versus Glipizide on the Progression of Atherosclerosis in Subjects With Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Glipizide

rosiglitazone maleate

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

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Patrocinadores