title: Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials.
abstract: OBJECTIVE
  Basal insulin analogues have a reduced risk of hypoglycaemia compared with NPH insulin, but hypoglycaemia still remains a major impediment to achieving recommended fasting plasma glucose (FPG) targets in patients with diabetes. Insulin degludec (IDeg) is a new basal insulin that forms soluble multihexamers after subcutaneous injection resulting in an ultra-long duration of action and stable glucose-lowering effect. The aim of this analysis was to compare the effect of IDeg on FPG and nocturnal confirmed hypoglycaemia as compared to insulin glargine (IGlar).
  
  
  RESULTS
  Data were included from seven phase 3a, randomised, open-label, treat-to-target clinical trials in which once-daily IDeg was compared with once-daily IGlar. Two trials included a total of 957 patients with type 1 diabetes (T1D) and five trials included a total of 3360 patients with type 2 diabetes (T2D); all trials were 26 or 52 weeks in duration. Confirmed hypoglycaemia was defined as plasma glucose <3.1 mmol/L or severe episodes requiring assistance, and nocturnal hypoglycaemia occurred between 00:01 and 05:59. In all trials, the mean end-of-trial FPG was lower for IDeg than IGlar, reaching statistical significance in three trials. Similarly, IDeg was associated with a lower rate of nocturnal confirmed hypoglycaemia vs. IGlar, which was statistically significant in three trials, regardless of type of diabetes or background therapy.
  
  
  CONCLUSIONS
  This analysis shows that the lower rate of nocturnal confirmed hypoglycaemia seen with IDeg relative to IGlar is accompanied by a reduced mean FPG, in particular in patients with T2D.
authors.affiliation: Royal Surrey County Hospital, University of Surrey, Guildford, UK. Electronic address: Davidrussell-jones@nhs.net.
authors.forename: D
authors.initials: D
authors.lastname: Russell-Jones
authors.affiliation: Novo Nordisk A/S, Soeborg, Denmark.
authors.forename: M-A
authors.initials: MA
authors.lastname: Gall
authors.affiliation: Novo Nordisk, Mainz, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Niemeyer
authors.affiliation: VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Diamant
authors.affiliation: University of Pisa, Pisa, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Del Prato
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005215:Fasting; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced*; D000069036:Insulin Glargine / Q000009:adverse effects / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic
chemical_list: D001786:Blood Glucose; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine; C571886:insulin degludec
keywords: Diabetes; Fasting plasma glucose; Hypoglycaemia; Insulin therapy; Meta-analysis