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Evidence-Based Medicine 2009;14:139; doi:10.1136/ebm.14.5.139
Copyright © 2009 by the BMJ Publishing Group Ltd.

OTHER

Therapeutics

Adding metformin to insulin did not improve a composite of microvascular and macrovascular disease in type 2 diabetes

The first 150 words of the full text of this article appear below.

Study design

Design:

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

Allocation:

{concealed}*.{dagger}

Blinding:

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

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 weight, blood pressure [BP], insulin dose, haemoglobin [Hb] A1c, and lipid concentrations). The study had 75% power to detect a >=8% difference between groups in the primary composite end point at . . . [Full text of this article]

Vivian Fonseca

Scott and White Clinic, Texas A & M Health Sciences Center; Temple, Texas, USA


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