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

NCT00879970 Phase 4 TERMINATED Results posted

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

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	TERMINATED
Enrolment	1332
Start date	2009-05
Completion	2010-11

Conditions

• Diabetes Mellitus, Type 2

Interventions

• pioglitazone
• rosiglitazone
• placebo
• Vitamin D
• Placebo

Primary outcomes

• Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) — From Randomization at Visit 3 up to the Final Visit (average of 162 days)
  An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function\[s\] due to disturbance in the blood supply to the brain not leading to death).
• Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D — From Randomization at Visit 3 to Final Visit (up to 162 days)
  An EAC adjudicated all occurrences of the components of the composite outcome for vitamin D. Components are the first occurrence of death or cancer requiring hospitalization, treatment with medicines (chemotherapy), or surgery.

Countries

United States, Argentina, Canada, Chile, Colombia, Czechia, Denmark, Finland, Germany, India, Italy, Latvia, Mexico, Netherlands, Norway, Pakistan, Peru, Philippines, Romania, Russia, Slovakia, South Africa, Sweden, Thailand, United Kingdom