Bartley 2008.

Study characteristics
Methods	Design: parallel‐group RCT; non‐inferiority design; randomisation ratio: 2:1
Participants	Inclusion criteria: ≥ 18 years; with an HbA1c ≤ 11.0% and BMI ≤ 35.0 kg/m2 with a history of T1DM ≥ 1 year treated on a basal–bolus insulin regimen for ≥ 3 months and able and willing to SMPG Exclusion criteria: proliferative retinopathy or maculopathy, other significant medical disorders, recurrent major hypoglycaemia, allergy to insulin and pregnant or breast feeding Diagnostic criteria: — Number of study centres: 33
Interventions	Intervention(s): detemir Comparator(s): NPH Duration of intervention: 24 months Duration of follow‐up: 24 months (plus 4 to 8 days) Run‐in period: none
Outcomes	Reported outcome(s) in full text of publication: glycaemic control, hypoglycaemia, safety
Study registration	Trial identifier: NCT00184665; NN304‐1595 Study terminated early: no
Publication details	Language of publication: English Funding: commercial funding (Novo Nordisk) Publication status: peer‐reviewed journal and conference abstract
Stated aim of study	Quote: "This 24‐month, multi‐national, open‐label, parallel group trial investigated the long‐term efficacy and safety of insulin detemir and Neutral Protamine Hagedorn insulin in combination with mealtime insulin aspart in patients with Type 1 diabetes using a treat‐to‐target concept"
Notes	Quote: "Six months into the trial, blinded review of the pre‐breakfast and pre‐evening meal PG concentrations revealed that PG targets were not achieved in a substantial proportion of patients and a protocol amendment was implemented to ensure more frequent contact between patients and investigators during the last year of the trial".CSR identified: from CSR data from hypoglycaemia combined with HbA1c, adverse events, serious adverse events, ketoacidosis and myocardial infarction