title: Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN(®) Basal-Bolus Type 1): 2-year results of a randomized clinical trial.
abstract: OBJECTIVE
  The goal of this study was to compare the long-term safety and efficacy of the basal insulin analogue, insulin degludec with insulin glargine (both with insulin aspart) in Type 1 diabetes, over a 2-year time period.
  
  
  METHODS
  This open-label trial comprised a 1-year main trial and a 1-year extension. Patients were randomized to once-daily insulin degludec or insulin glargine and titrated to pre-breakfast plasma glucose values of 3.9-4.9 mmol/l.
  
  
  RESULTS
  The rate of nocturnal confirmed hypoglycaemia was 25% lower with insulin degludec than with insulin glargine (P = 0.02). Rates of confirmed hypoglycaemia, severe hypoglycaemia and adverse events, and reductions in glycated haemoglobin and fasting plasma glucose were similar between groups. Despite achieving similar glycaemic control, insulin degludec-treated patients used 12% less basal and 9% less total daily insulin than did insulin glargine-treated patients (P < 0.01).
  
  
  CONCLUSIONS
  Long-term basal therapy using insulin degludec in Type 1 diabetes required lower doses and was associated with a 25% lower risk for nocturnal hypoglycaemia than insulin glargine.
authors.affiliation: Atlanta Diabetes Associates, Atlanta, GA, USA.
authors.forename: B W
authors.initials: BW
authors.lastname: Bode
authors.forename: J B
authors.initials: JB
authors.lastname: Buse
authors.forename: M
authors.initials: M
authors.lastname: Fisher
authors.forename: S K
authors.initials: SK
authors.lastname: Garg
authors.forename: M
authors.initials: M
authors.lastname: Marre
authors.forename: L
authors.initials: L
authors.lastname: Merker
authors.forename: E
authors.initials: E
authors.lastname: Renard
authors.forename: D L
authors.initials: DL
authors.lastname: Russell-Jones
authors.forename: C T
authors.initials: CT
authors.lastname: Hansen
authors.forename: A
authors.initials: A
authors.lastname: Rana
authors.forename: S R
authors.initials: SR
authors.lastname: Heller
mesh_terms: D000704:Analysis of Variance; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D061267:Insulin Aspart / Q000008:administration & dosage / Q000009:adverse effects; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000008:administration & dosage / Q000009:adverse effects; D061385:Insulins / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; D061385:Insulins; D000069036:Insulin Glargine; C571886:insulin degludec; D061267:Insulin Aspart