Kobayashi 2007.

Study characteristics
Methods	Design: parallel‐group RCT; non‐inferiority design; randomisation ratio: 2:1
Participants	Inclusion criteria: duration of diabetes mellitus for at least 2 years; current treatment of basal‐bolus regimen for at least 12 weeks using an intermediate/long‐acting human insulin and insulin aspart; HbA1c < 11.0%; BMI < 30 kg/m2 Exclusion criteria: impaired renal function; impaired hepatic function; serious heart diseases; known hypoglycaemia unawareness or recurrent major hypoglycaemia; proliferative retinopathy or maculopathy requiring acute treatment; uncontrolled treated/untreated hypertension; current treatment with total insulin dose of more than 100 IU/day; current treatment or expected at the screening to start treatment with systemic corticosteroids Diagnostic criteria: — Number of study centres: 52
Interventions	Intervention(s): detemir Comparator(s): NPH Duration of intervention: 48 weeks Duration of follow‐up: 48 weeks (plus 2 to 9 days) Run‐in period: none
Outcomes	Reported outcome(s) in full text of publication: all‐cause mortality, hypoglycaemia, adverse events, HbA1c
Study registration	Trial identifier: NN304‐1476; JapicCTI‐R070008; NCT00604344 Study terminated early: no
Publication details	Language of publication: Japanese Funding: commercial funding (Novo Nordisk) Publication status: peer‐reviewed journal, conference abstracts and clinical study synopsis, 3 pages from CSR
Stated aim of study	Quote: "A 48‐week, randomised, multi‐centre, open‐labelled, parallel‐group trial to compare the efficacy and the safety of NN304 (insulin detemir) and NPH human insulin in participants with insulin requiring diabetes mellitus on a basal‐bolus regimen"
Notes	Included both people with T1DM and T2DM, but separate data provided CSR provided data on diabetic ketoacidosis