NCT00595374.

Study characteristics
Methods	Design: parallel‐group RCT; non‐inferiority design; randomisation ratio: 2:1
Participants	Inclusion criteria: duration of T1DM > 12 months, > 18 years; BMI below 35 kg/m2, HbA1c between 7.0‐12.0%; current treatment with pre‐prandial short‐acting insulin and insulin NPH once or twice daily for at least 6 months Exclusion criteria: known or suspected allergy to study product or related products, receipt of any investigational products within the last 2 months prior to this study; drug or alcohol dependence, pregnancy, breastfeeding or intention of becoming pregnant Diagnostic criteria: — Number of study centres: 17
Interventions	Intervention(s): detemir Comparator(s): NPH Duration of intervention: 26 weeks Duration of follow‐up: 26 weeks (+ 7 days) Run‐in period: 2 weeks
Outcomes	Reported outcome(s) in full text of publication: no full text available
Study registration	Trial identifier: NCT00595374; NN304‐1582 Study terminated early: no
Publication details	Language of publication: not published Funding: commercial funding (Novo Nordisk) Publication status: unpublished study. Data extraction based on ClinicalTrials.gov and clinical study synopsis
Stated aim of study	Quote: "The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control"
Notes	"The primary efficacy variable, the HbA1c showed no statistically significant difference between NPH insulin and insulin detemir for both the Full Analysis Set (FAS) and the Per‐Protocol‐Set (PPS)" and "Both overall and nocturnal analyses show no statistically significant difference in incidence of hypoglycaemic episodes." and "The results indicate that the mean class level of nocturnal hypoglycaemic episode shows no statistically significant difference between NPH insulin and insulin detemir for the FAS (P = 0.2119)" and "Seven patients experienced a total of 10 serious adverse events" Novo Nordisk replied that no CSR was available for this study