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

Vague 2003.

*Study characteristics*
Methods	Design: parallel‐group RCT; non‐inferiority design; randomisation ratio: 1:1
Participants	Inclusion criteria: T1DM for at least 1 year; received basal (once or multiple times daily) bolus insulin treatment for at least 2 months; HbA1c level ≤ 12%, BMI ≤ 35kg/m²; total basal insulin dosage of ≤ 100 IU/day Exclusion criteria: proliferative retinopathy; impaired hepatic or renal function; severe cardiac problems; uncontrolled hypertension; recurrent major hypoglycaemia; allergy to insulin; pregnancy and breastfeeding Diagnostic criteria: — Number of study centres: 46
Interventions	Intervention(s): detemir Comparator(s): NPH Duration of intervention: 6 months Duration of follow‐up: 6 months (12 months) Run‐in period: none
Outcomes	Reported outcome(s) in full text of publication: HbA1c, safety, hypoglycaemia
Study registration	Trial identifier: NN304‐1205; extension trial: NN304‐1316 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 aim of this trial was to evaluate the metabolic control, risk of hypoglycemia, and other potential effects of treatment with insulin detemir in patients with type 1 diabetes on such a basal‐bolus regimen"
Notes	Patients completing the initial 6‐month trial were invited to participate in the extension phase, with 316 of 425 accepting CSR reported mortality, serious adverse events and ketoacidosis Additional information available from FDA review (mortality) (FDA 2002). EMA document provided no additional data (EMA 2004)

—: denotes not reported

ADA: American Diabetes Association ALAT: alanine aminotransferase ASAT: aspartate‐aminotransferase BG: blood glucose BMI: body mass index BP: blood pressure FBG: fasting blood glucose CGM: continuous glucose monitoring CGMS: continuous glucose monitoring system CSR: clinical study report DM: diabetes mellitus DiabMedSat: diabetes medication satisfaction DPM: diabetes productivity measure EMA: European Medicine Agency EudraCT: European Union Drug Regulating Authorities Clinical Trials Database FAS: full analysis set FDA: Food and Drug Administration HbA1c: glycosylated haemoglobin A1c HI: human insulin IAsp: insulin aspart IDeg: insulin degludec IDet: insulin detemir IGlar: insulin glargine IU: international units MAO: monoamine oxidase MDI: multiple daily injection NPH: neutral protamine Hagedorn NYHA: New York Heart Association PG: plasma glucose PM: post meridiem PPS: per‐protocol set QD: quaque die (daily) SF‐36: short‐form 36 SMBG: self‐monitoring of blood glucose SMPG: self‐measured plasma glucose RCT: randomised controlled trial T1DM: type 1 diabetes mellitus T2DM: type 2 diabetes mellitus Trim‐D: treatment related impact measure for diabetes