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Design: Placebo-controlled randomised controlled trial.
Allocation: Via computer generated sequence.
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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