Study design

Design:

randomised placebo-controlled trial (Hyperinsulinemia: the Outcome of its Metabolic Effects [HOME]). ClinicalTrials.gov NCT00375388.

Allocation:

{concealed}*.†

Blinding:

blinded (patients, clinicians, {data collectors, outcome assessors, data analysts, safety committee, and writers}*).†

Study question

Setting:

outpatient clinics of 3 hospitals in Hoogeveen, Meppel, and Coevorden, the Netherlands.

Patients:

390 patients 30–80 years of age (mean age 61 y, 54% women) who had type 2 diabetes.

Intervention:

metformin hydrochloride, 850 mg 1–3 times daily (n = 196), or matching placebo (n = 194), with insulin therapy.

Outcomes:

composite of microvascular and macrovascular disease (myocardial infarction [MI]; heart failure; acute coronary syndrome; peripheral arterial disease; sudden death; progression of retinopathy, nephropathy, or neuropathy; and 9 other items). Secondary outcomes included microvascular disease, macrovascular disease, and metabolic end points (body …