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

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Study design


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




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

Study question


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


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


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


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 …

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  • Source of funding: Altana; Lifescan; E. Merck/Santé Merck, Sharpe, & Dohme; Novo Nordisk.