R R Holman

Dr R R Holman, Diabetic Trials Unit, Oxford, UK; rury.holman@dtu.ox.ac.uk

STUDY DESIGN

Design:

randomised controlled trial (UK Prospective Diabetes Study [UKPDS]). Current Controlled Trials ISRCTN75451837.

Allocation:

{concealed}*.†

Blinding:

blinded (outcome adjudication committee).†

STUDY QUESTION

Setting:

23 centres in the UK.

Patients:

4209 patients 25–65 years of age {mean age 53 y, 60% men}* who had newly diagnosed type 2 diabetes and fasting plasma glucose concentrations >6.0 mmol/l (108 mg/dl) and <15.0 mmol/l (270 mg/dl) after 3 months of dietary therapy. Exclusion criteria included recent myocardial infarction, current angina or heart failure, and >1 major vascular event.

Intervention:

intensive glucose control with a sulfonylurea or insulin (n = 2729) or conventional therapy with diet (n = 1138). Overweight patients were also allocated to a third group involving intensive therapy with metformin (n = 342).

Outcomes:

7 composite outcomes (any diabetes-related end point, diabetes-related death, death from any cause, myocardial infarction, stroke, peripheral vascular disease, and microvascular disease).

Follow-up period:

median 9 years after the end of the trial, 17 years total.

Patient follow-up:

80–97% (intention-to-treat analysis). …