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. 2021 Mar 4;2021(3):CD013498. doi: 10.1002/14651858.CD013498.pub2

Davies 2014.

Study characteristics
Methods Design: parallel‐group RCT; non‐inferiority design; randomisation ratio: 1:1
Participants Inclusion criteria: adults (≥ 18 years or ≥ 20 years for Japan) diagnosed with T1DM for ≥ 12 months, currently treated with any basal–bolus insulin regimen for ≥ 12 months prior to screening and with HbA1c ≤ 10.0% (85.8 mmol/mol) and BMI ≤ 35.0 kg/m2, For Japan only: minimum age was 20 years
For the extension study only: completed the six‐month treatment period in study NN1250‐3585 (NCT01074268)
Exclusion criteria: clinically significant concomitant diseases, including impaired renal and hepatic function; recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months; and cardiovascular disease within the previous 6 months prior to the study, use of any other antidiabetic drug than insulin within the last 3 months, uncontrolled treated/untreated severe hypertension, pregnancy, breast‐feeding, the intention of becoming pregnant or not using adequate contraceptive measures, cancer and medical history of cancer
Diagnostic criteria: —
Number of study centres: 55 sites (in 7 countries)
Interventions Intervention(s): degludec
Comparator(s): detemir
Duration of intervention: 26 weeks
Duration of follow‐up: 26 weeks (52 weeks)
Run‐in period: none
Number of study centres: 55 sites (in 7 countries)
Outcomes Reported outcome(s) in full text of publication: glycaemic control, hypoglycaemia, safety
Study registration Trial identifier: NCT01074268; NN1250‐3585 (26 weeks); NCT01190956; obsolete identifiers: NCT01190956; EudraCT number: 2009‐011672‐29 and 2009‐015721‐36; WHO identifier: U1111‐1111‐7249 and U1111‐1114‐9479; JAPIC Identifier: JapicCTI‐10106 and JapicCTI‐22‐0677; extension study: NN1250‐3725; main study: CTRI/2010/091/000145; extension study: CTRI/2010/091/001097
Study terminated early: no
Publication details Language of publication: English
Funding: commercial funding (Novo Nordisk)
Publication status: peer‐reviewed journal
Stated aim of study Quote: "The primary outcome was non‐inferiority of IDeg to IDet in glycated haemoglobin (HbA1c) reduction after 26 weeks"
Notes Participants who completed the core study were invited to participate in a 26‐week extension study
Data were entered after 26 weeks of intervention
DiabMedSat (Diabetes Medication Satisfaction), DPM (Diabetes Productivity Measure), TRIM‐D (Treatment Related Impact Measure for Diabetes) and SF‐36 v2 were reported by the investigators and CSR
CSR and synopsis available ‐ added information in combined HbA1c and severe hypoglycaemia
Study also reported in FDA 2015 document (FDA 2015)‐ no additional data. No additional data from EMA 2012 (EMA 2012)