Thalange 2013.

Study characteristics
Methods	Design: parallel‐group RCT; non‐inferiority design; randomisation ratio: 1:1
Participants	Inclusion criteria: T1DM for at least 12 months; age 2‐16 years; total daily insulin dose ≤ 2.0 U/kg; insulin detemir naive; HbA1c less or equal to 11%; BMI ≤ 27 kg/m2 Exclusion criteria: significant concomitant disease Diagnostic criteria: — Number of study centres: 35
Interventions	Intervention(s): detemir Comparator(s): NPH Duration of intervention: 52 weeks Duration of follow‐up: 104 weeks (only for the detemir group) Run‐in period: none
Outcomes	Reported outcome(s) in full text of publication: adverse events, ketoacidosis, HbA1c, hypoglycaemia
Study registration	Trial identifier: NN304‐1689; EudraCT 2006‐000051‐18; NCT00435019 (main study); NCT00623194 (extension study); NN304‐1690 (extension study) Study terminated early: no
Publication details	Language of publication: English Funding: commercial funding (Novo Nordisk) Publication status: peer‐reviewed journal
Stated aim of study	Quote: "This 52‐week, randomized, multinational, open‐label, parallel‐group, non‐inferiority trial investigated the efficacy and safety of basal–bolus treatment with insulin detemir vs. NPH (neutral protamine Hagedorn) insulin, in combination with insulin aspart, in participants aged 2–16 years with Type 1 diabetes mellitus"
Notes	A total of 10 scheduled visits to the clinical study sites and 8 telephone contacts. Only participants in the detemir group were invited to extended follow‐up Quote: "Children in the IDet arm who completed this study were offered the option to continue treatment with IDet (once or twice daily) together with IAsp (2–4 times daily with meals) for a further 52 weeks (extension study), for a total of 104 weeks of treatment (total treatment period)" The CSR did not add any additional information on outcomes. Additional information on baseline variables were identified Described in EMA 2011 report, but no additional outcomes provided (EMA 2011)