title: Comparison of insulin degludec with insulin detemir in type 1 diabetes: a 1-year treat-to-target trial.
abstract: The long-term safety and tolerability of insulin degludec (IDeg) was compared with that of insulin detemir (IDet), as basal treatment in participants with type 1 diabetes mellitus (T1DM). In the present multinational, 26-week core + 26-week extension, controlled, open-label, parallel-group trial, adults with T1DM were randomized to IDeg or IDet as basal insulin treatment combined with meal-time bolus insulin aspart. IDeg was administered once daily, whilst IDet was administered once or twice daily depending on patients' glycaemic control. After 1 year, IDeg provided a 33% lower rate of nocturnal hypoglycaemia compared with IDet: estimated rate ratio (IDeg : IDet) 0.67 [95% confidence interval (CI) 0.51; 0.88]; p < 0.05. IDeg improved glycated haemoglobin after 1 year of treatment, similarly to IDet, but IDeg also provided a significantly greater reduction in fasting plasma glucose compared with IDet: estimated difference (IDeg - IDet) -1.11 (95% CI -1.83; -0.40) mmol/l; p < 0.05. The present study confirmed the long-term safety and tolerability profile of IDeg in patients with T1DM. IDeg provided a lower risk of nocturnal confirmed hypoglycaemia than IDet.
authors.affiliation: Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.
authors.forename: M
authors.initials: M
authors.lastname: Davies
authors.affiliation: Internal Medicine, Sasaki Hospital Internal Medicine, Hokkaido, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Sasaki
authors.affiliation: Centro de Pesquisas em Diabetes, Porto Alegre, Brazil.
authors.forename: J L
authors.initials: JL
authors.lastname: Gross
authors.affiliation: Department of Endocrinology, St. Johns Medical College Bangalore, Bangalore, India.
authors.forename: G
authors.initials: G
authors.lastname: Bantwal
authors.affiliation: Internal Medicine, Yuri Ono Clinic, Hokkaido, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Ono
authors.affiliation: Novo Nordisk Pharma Ltd, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Nishida
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: D
authors.initials: D
authors.lastname: Tojjar
authors.affiliation: Internal Medicine, Seino Internal Medicine Clinic, Fukushima, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Seino
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis / Q000187:drug effects; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005215:Fasting / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000187:drug effects; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D061267:Insulin Aspart / Q000008:administration & dosage; D000069057:Insulin Detemir / Q000008:administration & dosage*; D049528:Insulin, Long-Acting / Q000008:administration & dosage*; D008297:Male; D062407:Meals; D008875:Middle Aged; D013995:Time
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human; C571886:insulin degludec
keywords: basal-bolus; hypoglycaemia; insulin aspart; insulin degludec; insulin detemir; insulin therapy; type 1 diabetes mellitus