Chase 2008.

Study characteristics
Methods	Design: parallel‐group RCT; non‐inferiority design; randomisation ratio: 1:1
Participants	Inclusion criteria: ≥ 9 to ≤ 17 years; Tanner stage ≥ 2; HbA1c ≥ 7.0% to ≤ 9.5%) who had a diagnosis of T1DM for at least 1 year and were receiving any daily insulin regimen consisting of 2 or more injections or a continuous subcutaneous insulin infusion, ability and willingness to count carbohydrates and perform SMBG testing at least 4 times per day Exclusion criteria: clinically relevant cardiovascular, hepatic, renal, neurologic, endocrine, or other major systemic diseases; psychiatric problems; laboratory test abnormalities; a history of 2 or more episodes of severe hypoglycaemia within the past 12 months or diabetic ketoacidosis in the past 3 months; or hypersensitivity to the investigational product or treatment; lipohypertrophy, a history of drug or alcohol abuse, current use of systemic corticosteroids or large doses of inhaled corticosteroids, and pregnancy Diagnostic criteria: fasting C‐peptide concentration of ≤ 0.5 nmol/L Number of study centres: 40
Interventions	Intervention(s): glargine Comparator(s): NPH/Lente Duration of intervention: 24 weeks Duration of follow‐up: 25 weeks (the treatment period was followed by a 1‐week follow‐up) Run‐in period: 4 weeks (during the educational run‐in period, patients received instruction from a certified diabetes educator on carbohydrate counting and basal/bolus insulin regimens)
Outcomes	Reported outcome(s) in full text of publication: serious adverse events, hypoglycaemia, HbA1c
Study registration	Trial identifier: HOE901/4030; NCT00046501 Study terminated early: no
Publication details	Language of publication: English Funding: commercial funding (Sanofi) Publication status: peer‐reviewed journal
Stated aim of study	Quote: "To compare long‐acting insulin glargine (Lantus) with intermediate‐acting insulin (neutral protamine Hagedorn [NPH]/Lente) when used as the basal component of a multiple daily injection (MDI) regimen with prandial insulin lispro (Humalog) in adolescents with type 1 diabetes mellitus (T1DM)"
Notes	Only three participants in the NPH/Lente group received Lente Subset of participants had CGM Clinical study summary available from Sanofis web page. This stated that The Diabetes Quality of Life for Youth questionnaire was applied. In the study summary, it was mentioned that more reported treatment emergent adverse events were observed in the glargine group compared with the NPH group From CSR, data for mortality and adverse events were retrieved