EudraCT 2009‐012317‐22.

Methods	Allocation: randomised Intervention model: parallel‐group assignment Masking: open‐label Primary purpose: treatment
Participants	Condition: T1DM Estimated number of participants: 16 Inclusion criteria: aged >= 6 and < 11 years; HbA1c < 7.5%; basal C‐peptide < 0.1 nmol/L Exclusion criteria: clinical signs of puberty illness associated with T1DM, using any drug except insulin, clinically relevant microalbuminuria, non‐availability of blood samples
Interventions	Intervention(s): glargine Comparator(s): detemir Duration of the intervention: 1 year (not explicitly stated ‐ could also be 4 months)
Outcomes	Primary outcome(s): GH and IGF‐1 levels Secondary outcome(s): — Other outcome(s): — Relevant proposed outcome measures for SoF table: —
Reason for awaiting classification	Marked as 'completed' in EU Clinical Trial Register but no publication available
Study details	Study identifier: EudraCT 2009‐012317‐22 Study start date: June 2009 Study completion date: — (listed as completed) Responsible party/principal investigator: GM Lancise, Azienda Ospedaliero Universitaria Ospedali Ruinti Umberte, Italy
Official title and purpose of study	Pediatric basal bolus therapy ‐ Basal‐bolus regimen in the treatment of children with type 1 diabetes Quote: "...to study the difference of GH/IGF1 axis in children treated with glargine or detemir"
Notes	Primary investigator contacted. No reply