title: Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine.
abstract: OBJECTIVE
  Insulin degludec (IDeg) is a basal insulin that forms soluble multihexamers after subcutaneous injection, resulting in an ultra-long action profile. We assessed the efficacy and safety of IDeg formulations administered once daily in combination with mealtime insulin aspart in people with type 1 diabetes.
  
  
  METHODS
  In this 16-week, randomized, open-label trial, participants (mean: 45.8 years old, A1C 8.4%, fasting plasma glucose [FPG] 9.9 mmol/L, BMI 26.9 kg/m(2)) received subcutaneous injections of IDeg(A) (600 μmol/L; n = 59), IDeg(B) (900 μmol/L; n = 60), or insulin glargine (IGlar; n = 59), all given once daily in the evening. Insulin aspart was administered at mealtimes. RESULTS At 16 weeks, mean A1C was comparable for IDeg(A) (7.8 ± 0.8%), IDeg(B) (8.0 ± 1.0%), and IGlar (7.6 ± 0.8%), as was FPG (8.3 ± 4.0, 8.3 ± 2.8, and 8.9 ± 3.5 mmol/L, respectively). Estimated mean rates of confirmed hypoglycemia were 28% lower for IDeg(A) compared with IGlar (rate ratio [RR]: 0.72 [95% CI 0.52-1.00]) and 10% lower for IDeg(B) compared with IGlar (RR: 0.90 [0.65-1.24]); rates of nocturnal hypoglycemia were 58% lower for IDeg(A) (RR: 0.42 [0.25-0.69]) and 29% lower for IDeg(B) (RR: 0.71 [0.44-1.16]). Mean total daily insulin dose was similar to baseline. The frequency and pattern of adverse events was similar between insulin treatments.
  
  
  CONCLUSIONS
  In this clinical exploratory phase 2 trial in people with type 1 diabetes, IDeg is safe and well tolerated and provides comparable glycemic control to IGlar at similar doses, with reduced rates of hypoglycemia.
authors.affiliation: Oslo University Hospital and Faculty of Medicine, Oslo, Norway. k.i.birkeland@medisin.uio.no
authors.forename: Kåre I
authors.initials: KI
authors.lastname: Birkeland
authors.forename: Philip D
authors.initials: PD
authors.lastname: Home
authors.forename: Ulrich
authors.initials: U
authors.lastname: Wendisch
authors.forename: Robert E
authors.initials: RE
authors.lastname: Ratner
authors.forename: Thue
authors.initials: T
authors.lastname: Johansen
authors.forename: Lars A
authors.initials: LA
authors.lastname: Endahl
authors.forename: Karsten
authors.initials: K
authors.lastname: Lyby
authors.forename: Johan H
authors.initials: JH
authors.lastname: Jendle
authors.forename: Anthony P
authors.initials: AP
authors.lastname: Roberts
authors.forename: J Hans
authors.initials: JH
authors.lastname: DeVries
authors.forename: Luigi F
authors.initials: LF
authors.lastname: Meneghini
mesh_terms: D000328:Adult; D000368:Aged; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine; C571886:insulin degludec