title: Effects of insulin degludec and insulin glargine on day-to-day fasting plasma glucose variability in individuals with type 1 diabetes: a multicentre, randomised, crossover study.
abstract: OBJECTIVE
  We compared the effects of insulin degludec (IDeg; Des(B30)LysB29(γ-Glu Nε-hexadecandioyl) human insulin) and insulin glargine (IGlar; A21Gly,B31Arg,B32Arg human insulin) on the day-to-day variability of fasting plasma glucose (FPG) levels in individuals with type 1 diabetes treated with basal-bolus insulin injections.
  
  
  METHODS
  The effects of basal-bolus insulin therapy for 4 weeks with either IDeg or IGlar as the basal insulin in adult C-peptide-negative outpatients with type 1 diabetes were investigated in an open-label, multicentre, randomised, crossover trial. Randomisation was conducted using a centralised allocation process. The primary endpoints were the SD and CV of FPG during the final week of each treatment period. Secondary endpoints included serum glycoalbumin level, daily dose of insulin, intraday glycaemic variability and frequency of severe hypoglycaemia.
  
  
  RESULTS
  Thirty-six randomised participants (17 in the IDeg/IGlar and 19 in the IGlar/IDeg groups) were recruited, and data for 32 participants who completed the trial were analysed. The mean (7.74 ± 1.76 vs 8.56 ± 2.06 mmol/l; p = 0.04) and SD (2.60 ± 0.97 vs 3.19 ± 1.36 mmol/l; p = 0.03) of FPG were lower during IDeg treatment than during IGlar treatment, whereas the CV did not differ between the two treatments. The dose of IDeg was smaller than that of IGlar (11.0 ± 5.2 vs 11.8 ± 5.6 U/day; p < 0.01), but other secondary endpoints did not differ between the treatments.
  
  
  CONCLUSIONS
  IDeg yielded a lower FPG level and smaller day-to-day variability of FPG at a lower daily dose compared with IGlar in participants with type 1 diabetes. IDeg serves as a good option for basal insulin in the treatment of type 1 diabetes.
  
  
  BACKGROUND
  University Hospital Medical Information Network 000009965.
  
  
  BACKGROUND
  This research recieved no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
authors.affiliation: Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Nakamura
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Sakaguchi
authors.forename: Anna
authors.initials: A
authors.lastname: So
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Nakajima
authors.forename: Michinori
authors.initials: M
authors.lastname: Takabe
authors.forename: Hisako
authors.initials: H
authors.lastname: Komada
authors.forename: Yoko
authors.initials: Y
authors.lastname: Okuno
authors.forename: Yushi
authors.initials: Y
authors.lastname: Hirota
authors.forename: Takehiro
authors.initials: T
authors.lastname: Nakamura
authors.forename: Keiji
authors.initials: K
authors.lastname: Iida
authors.forename: Michiko
authors.initials: M
authors.lastname: Kajikawa
authors.forename: Masao
authors.initials: M
authors.lastname: Nagata
authors.forename: Wataru
authors.initials: W
authors.lastname: Ogawa
authors.forename: Susumu
authors.initials: S
authors.lastname: Seino
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D002096:C-Peptide / Q000097:blood / Q000737:chemistry; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000150:complications; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood / Q000378:metabolism; D000069036:Insulin Glargine / Q000008:administration & dosage*; D000078790:Insulin Secretion; D049528:Insulin, Long-Acting / Q000008:administration & dosage*; D061386:Insulin, Regular, Human / Q000097:blood; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results
chemical_list: D001786:Blood Glucose; D002096:C-Peptide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; D061386:Insulin, Regular, Human; C517652:hemoglobin A1c protein, human; C571886:insulin degludec