title: Efficacy and safety of once-daily insulin degludec/insulin aspart compared with once-daily insulin glargine in participants with Type 2 diabetes: a randomized, treat-to-target study.
abstract: To investigate, in a 26-week, open-label, randomized, treat-to-target trial, the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily vs insulin glargine (IGlar) once daily in adults with Type 2 diabetes, inadequately controlled on basal insulin.
  
  
  
  Participants were randomized (1:1) to IDegAsp once daily or IGlar once daily in combination with existing oral antidiabetic drugs. IDegAsp once daily was administered with the main evening meal or the largest meal of the day (agreed at baseline); dosing time was maintained throughout the trial. Participants titrated their insulin dose weekly to a mean pre-breakfast self-measured plasma glucose target [3.9-4.9 mmol/l (70-89 mg/dl)].
  
  
  
  IDegAsp once daily was non-inferior to IGlar once daily in reducing HbA1cafter 26 weeks [mean estimated treatment difference IDegAsp once daily - IGlar once daily: -0.03% (95% CI -0.20, 0.14)]. The evening meal glucose increment was significantly lower with IDegAsp once daily vs IGlar once daily [estimated treatment difference IDegAsp once daily - IGlar once daily: -1.32 mmol/l (95% CI -1.93, -0.72); P < 0.05]. The overall confirmed hypoglycaemia rate was higher with IDegAsp once daily (estimated rate ratio 1.43; 95% CI 1.07, 1.92; P < 0.05). The rate of nocturnal hypoglycaemia did not significantly differ between the IDegAsp and IGlar groups [estimated rate ratio 0.80 (95% CI 0.49, 1.30); not significant].
  
  
  
  In participants with Type 2 diabetes inadequately controlled on basal insulin, IDegAsp once daily improved glycaemic control and was non-inferior to IGlar once daily. IDegAsp led to higher rates of overall hypoglycaemia than IGlar, with no significant difference in rates of nocturnal hypoglycaemia.
authors.affiliation: Department of Diabetes, Diabetes Care Centre, Thiruvananthapuram, India.
authors.forename: S
authors.initials: S
authors.lastname: Kumar
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, South Korea.
authors.forename: H C
authors.initials: HC
authors.lastname: Jang
authors.affiliation: Department of Endocrinology, Baskent University Hospital, Altunizade, Istanbul, Turkey.
authors.forename: N G
authors.initials: NG
authors.lastname: Demirağ
authors.affiliation: Department of Medical and Science, Liraglutide and Obesity, Novo Nordisk A/S, Søborg, Denmark.
authors.forename: T V
authors.initials: TV
authors.lastname: Skjøth
authors.affiliation: Department of R&D Insight, Novo Nordisk A/S, Bagsvaerd, Denmark.
authors.forename: L
authors.initials: L
authors.lastname: Endahl
authors.affiliation: Atlanta Diabetes Associates, Atlanta, GA, USA.
authors.forename: B
authors.initials: B
authors.lastname: Bode
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004338:Drug Combinations; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000069036:Insulin Glargine / Q000008:administration & dosage* / Q000009:adverse effects; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010347:Patient Care Planning; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human; C578220:insulin degludec, insulin aspart drug combination