None listed
Conditions
Interventions
Trade Name: Avandia
Pharmaceutical Form: Over encapsulated tablet
CAS Number: 155141-29-0
Other descriptive name: ROSIGLITAZONE MALEATE
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women with: a) newly detected type 2 diabetes based on a fasting plasma glucose higher than 7.0 mmol/l (126 mg/dL) or a 2 hour plasma glucose higher than 11.1 mmol/l (200 mg/dL) on an oral glucose tolerance test, or b) a history of type 2 diabetes 2. A1C 6.5-9.5% inclusive 3. A) Age = 50 years and evidence of vascular disease(at least 1): a) prior myocardial infarction b) prior stroke c) coronary, carotid or peripheral artery 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 (at least 1): a) microalbuminuria or proteinuria b) history of treated or untreated hypertension with left ventricular hypertrophy by ECG or echocardiogram c) >50% stenosis on any imaging of coronary, carotid or lower extremity arteries d) ankle/brachial index 1.0 for men and > 0.8 for women 4. On no insulin and on less or equal than 2 anti-diabetes drugs (OAD) 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 5. A negative pregnancy test for all females of childbearing potential (i.e., ovulating, pre-menopausal, and not surgically sterile) and agreement to use adequate birth control (according to local regulations) throughout the study 6. Adherence =80% and tolerability to single-blind study medication during the run-in phase 7.Provision of signed and dated informed consent prior to any study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
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 indication or contraindication for vitamin D therapy 15. Clinically or medically unstable with expected survival < 1 year 16. Unwillingness to permit sites to contact their primary physicians to communicate information about the study and the participant’s data 17. Any other factor likely to limit protocol compliance or reporting of adverse events 18. Inability to discontinue a TZD (if taking one) in the judgement of the physician/investigator 19. Contraindications to or history of hypersensitivity to the investigational products 20. History of renal stones within the past 2 years 21. Participation in another clinical trial of an investigational agent 22. Previous randomization in this study French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This trial will determine the relative incidence of CV outcomes compared to placebo for the TZD class as a whole, rosiglitazone (RSG), and pioglitazone (PIO) when added to the therapeutic regimen of a person with type 2 diabetes who has additional risk factors for CV events. The trial will also separately determine whether adding vitamin D in such individuals is superior to adding placebo with respect to reducing the incidence of death or serious cancers requiring hospitalization, chemotherapy or surgery compared to placebo. This will be assessed both at the end of the TZD follow-up phase and then after up to 10 years of total follow-up. ;Secondary Objective: Secondary objectives (TZDs): assess at 4.5 years if rosiglitazone is non-inferior to pioglitazone with respect to the primary outcome and if pioglitazone is non-inferior to placebo with respect to the primary outcome. Assess if the addition of a TZD versus placebo for up to 5.5 years will reduce total mortality. We also aim to answer the questions: does the addition of rosiglitazone versus placebo for up to 5.5 years reduce: a) the primary outcome; b) total mortality; or c) microvascular outcomes?Does the addition of pioglitazone versus placebo for up to 5.5 years reduce a) the primary outcome; b) total mortality; or c) microvascular outcomes? Secondary questions (Vitamin D): a) does the addition of vitamin D for up to 10 years versus placebo reduce total mortality? b) does the addition of vitamin D versus placebo for up to 10 years reduce total fractures? ;Primary end point(s): The composite cardiovascular primary outcome for the TZD research questions is the first occurrence of either: a) cardiovascular (CV) death; b) nonfatal myocardial infarction (MI); or c) nonfatal stroke. The composite primary outcome for the vitamin D research question is death or serious cancer requiring hospitalization, chemotherapy or surgery. | — |
Countries
Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Latvia, Netherlands, Sweden, United Kingdom
Outcome results
None listed