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Adjunctive prandial or biphasic insulin for type 2 diabetes improved glycaemic control but increased hypoglycaemia and weight gain

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Dr R R Hollman

Correspondence to: Dr R R Hollman, Oxford Centre for Diabetes, Endocrinology, and Metabolism, Oxford, UK; rury.holman@dtu.ox.ac.uk

STUDY DESIGN

Design:

randomised controlled trial (Treating to Target in Type 2 Diabetes [4-T]).

Allocation:

concealed.*

Blinding:

unblinded.*

STUDY QUESTION

Setting:

58 centres in Ireland and the UK.

Patients:

708 patients ⩾18 years of age (mean age 62 y, 64% men) who had type 2 diabetes for ⩾12 months (median 9 y), suboptimal glycaemic control (haemoglobin [Hb] A1c concentration 7.0–10.0%, mean 8.5%) while receiving maximally tolerated doses of metformin and sulphonylurea for ⩾4 months, body mass index ⩽40 (mean 30) kg/m2, and no previous treatment with insulin. Exclusion criteria included thiazolidinedione or triple oral anti-diabetic therapy in ⩽6 months, severe retinopathy, plasma creatinine concentration ⩾130 μmol/l, cardiac disease, hepatic disease, and uncontrolled …

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