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Metformin with insulin does not improve the glycaemic control of overweight/obese adolescents with type 1 diabetes
  1. Angela Katrina Lucas-Herald1,
  2. Kenneth J Robertson2
  1. 1Developmental Endocrinology Research Group, University of Glasgow, Glasgow, UK
  2. 2Royal Hospital for Children, Glasgow, UK
  1. Correspondence to Dr Angela Katrina Lucas-Herald, Developmental Endocrinology Research Group, University of Glasgow, 1345 Govan Road, Glasgow G51 4TF, UK; angela.lucas-herald{at}glasgow.ac.uk

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Study design

Design: Placebo-controlled randomised controlled trial.

Allocation: Via computer generated sequence.

Blinding: Double-blind.

Study question

Setting: 26 paediatric endocrinology clinics in the Type 1 Diabetes Exchange Clinic Network between 2013 and 2014.

Patients: 140 adolescents aged between 12.1 and 19.6 years (mean (SD) 15.3 (1.7)) with type 1 diabetes for >1 year and a body mass index >85th centile for age, total daily insulin dose >0.8 units/kg and three times daily self-monitoring of blood glucose.

Intervention: 2000 mg daily dose metformin compared with placebo.

Outcomes: Primary outcome: change in haemoglobin A1c (HbA1c) from baseline to 26 weeks. Prespecified secondary outcomes: total daily dose (TDD) insulin per kg body weight, total basal insulin per kg body weight, anthropometry, blood pressure, metabolic profile.

Follow-up period …

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