title: One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial.
abstract: OBJECTIVE
  To confirm, in a 26-week extension study, the sustained efficacy and safety of a fixed combination of insulin degludec and liraglutide (IDegLira) compared with either insulin degludec or liraglutide alone, in patients with type 2 diabetes.
  
  
  METHODS
  Insulin-naïve adults with type 2 diabetes randomized to once-daily IDegLira, insulin degludec or liraglutide, in addition to metformin ± pioglitazone, continued their allocated treatment in this preplanned 26-week extension of the DUAL I trial.
  
  
  RESULTS
  A total of 78.8% of patients (1311/1663) continued into the extension phase. The mean glycated haemoglobin (HbA1c) concentration at 52 weeks was reduced from baseline by 1.84% (20.2 mmol/mol) for the IDegLira group, 1.40% (15.3 mmol/mol) for the insulin degludec group and 1.21% (13.2 mmol/mol) for the liraglutide group. Of the patients on IDegLira, 78% achieved an HbA1c of <7% (53 mmol/mol) versus 63% of the patients on insulin degludec and 57% of those on liraglutide. The mean fasting plasma glucose concentration at the end of the trial was similar for IDegLira (5.7 mmol/l) and insulin degludec (6.0 mmol/l), but higher for liraglutide (7.3 mmol/l). At 52 weeks, the daily insulin dose was 37% lower with IDegLira (39 units) than with insulin degludec (62 units). IDegLira was associated with a significantly greater decrease in body weight (estimated treatment difference, -2.80 kg, p < 0.0001) and a 37% lower rate of hypoglycaemia compared with insulin degludec. Overall, all treatments were well tolerated and no new adverse events or tolerability issues were observed for IDegLira.
  
  
  CONCLUSIONS
  These 12-month data, derived from a 26-week extension of the DUAL I trial, confirm the initial 26-week main phase results and the sustainability of the benefits of IDegLira compared with its components in glycaemic efficacy, safety and tolerability.
authors.affiliation: Oxford Centre for Diabetes, Endocrinology and Metabolism, and NIHR Oxford Biomedical Research Centre, Churchill Hospital, Oxford, UK.
authors.forename: S C L
authors.initials: SC
authors.lastname: Gough
authors.affiliation: Atlanta Diabetes Associates, Atlanta, GA, USA.
authors.forename: B W
authors.initials: BW
authors.lastname: Bode
authors.affiliation: Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.
authors.forename: V C
authors.initials: VC
authors.lastname: Woo
authors.affiliation: Endocrine and Metabolic Consultants, Rockville, MD, USA.
authors.forename: H W
authors.initials: HW
authors.lastname: Rodbard
authors.affiliation: Coffs Harbour Diabetes Clinic, Coffs Harbour, NSW, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Linjawi
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Zacho
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: P D
authors.initials: PD
authors.lastname: Reiter
authors.affiliation: Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: J B
authors.initials: JB
authors.lastname: Buse
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005215:Fasting / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D049528:Insulin, Long-Acting / Q000008:administration & dosage*; D000069450:Liraglutide / Q000008:administration & dosage*; D008297:Male; D008687:Metformin / Q000008:administration & dosage; D008875:Middle Aged; D000077205:Pioglitazone; D045162:Thiazolidinediones / Q000008:administration & dosage; D015431:Weight Loss / Q000187:drug effects
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; D000069450:Liraglutide; D008687:Metformin; D000077205:Pioglitazone; D045162:Thiazolidinediones; C517652:hemoglobin A1c protein, human; C571886:insulin degludec
keywords: diabetes therapy; hypoglycaemia; insulin degludec; liraglutide