Study Design

Study Design:

Patients Screened: 7616
Patients Enrolled: 5102
Mean Follow Up: up to 13 years
Female: 42

Patient Populations:

Fasting plasma glucose (FPG) greater than 6 mmol/L on two mornings, 1­3 weeks apart Age 25-65 years

Exclusions:

Ketonuria >3 mmol/L; serum creatinine >175 mmol/L; myocardial infarction in the previous year; current angina or heart failure; more than one major vascular event; retinopathy requiring laser treatment; malignant hypertension; uncorrected endocrine disorder; occupation that precluded insulin therapy; severe concurrent illness that would limit life or require extensive systemic treatment; inadequate understanding.

Primary Endpoints:

Time to the first occurrence of: any diabetes-related endpoint (sudden death, death from hyperglycemia or hypoglycemia, fatal or non-fatal MI, angina, heart failure, stroke, renal failure, amputation of at least one digit, vitreous hemorrhage, retinal photocoagulation, blindness in one eye, or cataract extraction); diabetes-related death (death from MI, stroke, peripheral vascular disease, renal disease, hyperglycemia or hypoglycemia, and sudden death); all-cause mortality.

Secondary Endpoints:

MI (fatal and non-fatal) and sudden death; stroke (fatal and non-fatal); amputation or death due to peripheral vascular disease; microvascular complications (retinopathy requiring photocoagulation, vitreous hemorrhage, and or fatal or non-fatal renal failure).

Drug/Procedures Used:

Patients were stratified by ideal bodyweight (overweight was >120% ideal bodyweight). Non-overweight patients were randomly assigned intensive treatment with insulin (30%), intensive treatment with sulphonylurea (40%), or conventional treatment with diet (30%). Overweight patients were randomly assigned treatment with the additional possibility of metformin. Overweight patients who were randomly allocated metformin therapy are reported separately.