Primary outcomes

• Deaths from any cause
• Major macrovascular events (a composite of nonfatal myocardial infarction, nonfatal stroke, and death from any cardiovascular cause)

Secondary outcomes

• Death from any cardiovascular cause
• Major clinical microvascular events
• Composite of major macrovascular clinical microvascular events
• Myocardial infarction (nonfatal and fatal)
• Stroke (nonfatal and fatal)
• Requirement for renal replacement therapy (dialysis or transplantation)
• Death from renal disease
• Development of severe diabetes-related eye disease
• Major hypoglycemia