title: Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial.
abstract: OBJECTIVE
  Insulin degludec/insulin aspart (IDegAsp) is the first combination of a basal insulin with an ultralong duration of action, and a rapid-acting insulin in a single injection. This trial compared IDegAsp with biphasic insulin aspart 30 (BIAsp 30) in adults with type 2 diabetes inadequately controlled with once- or twice-daily (OD or BID) pre- or self-mixed insulin with or without oral antidiabetic drugs.
  
  
  METHODS
  In this 26-week, randomized, open-label, multinational, treat-to-target trial, participants (mean age 58.7 years, duration of diabetes 13 years, BMI 29.3 kg/m(2), and HbA1c 8.4% [68 mmol/mol]) were exposed (1:1) to BID injections of IDegAsp (n = 224) or BIAsp 30 (n = 222), administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose (PG) target of 4.0-5.0 mmol/L.
  
  
  RESULTS
  After 26 weeks, mean HbA1c was 7.1% (54 mmol/mol) for both groups, with IDegAsp achieving the prespecified noninferiority margin for mean change in HbA1c (estimated treatment difference [ETD] -0.03% points [95% CI -0.18 to 0.13]). Treatment with IDegAsp was superior in lowering fasting PG (ETD -1.14 mmol/L [95% CI -1.53 to -0.76], P < 0.001) and had a significantly lower final mean daily insulin dose (estimated rate ratio 0.89 [95% CI 0.83-0.96], P = 0.002). Fewer confirmed, nocturnal confirmed, and severe hypoglycemia episodes were reported for IDegAsp compared with BIAsp 30.
  
  
  CONCLUSIONS
  IDegAsp BID effectively improves HbA1c and fasting PG levels with fewer hypoglycemia episodes versus BIAsp 30 in patients with uncontrolled type 2 diabetes previously treated with once- or twice-daily pre- or self-mixed insulin.
authors.affiliation: University of Sydney, Royal North Shore Hospital, Australia greg.fulcher@sydney.edu.au.
authors.forename: Gregory R
authors.initials: GR
authors.lastname: Fulcher
authors.affiliation: Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Jens Sandahl
authors.initials: JS
authors.lastname: Christiansen
authors.affiliation: St. Johns Medical College Hospital, Bangalore, India.
authors.forename: Ganapathi
authors.initials: G
authors.lastname: Bantwal
authors.affiliation: Bydgoszcz Diabetes and Endocrinology Center, Bydgoszcz, Poland.
authors.forename: Miroslawa
authors.initials: M
authors.lastname: Polaszewska-Muszynska
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Henriette
authors.initials: H
authors.lastname: Mersebach
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Andersen
authors.affiliation: School of Medicine, University of Eastern Finland, Helsingfors, Finland.
authors.forename: Leo K
authors.initials: LK
authors.lastname: Niskanen
mesh_terms: D061265:Biphasic Insulins / Q000008:administration & dosage* / Q000009:adverse effects; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005215:Fasting / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000188:drug therapy; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007267:Injections; D061267:Insulin Aspart / Q000008:administration & dosage* / Q000009:adverse effects; D007336:Insulin, Isophane / Q000008:administration & dosage* / Q000009:adverse effects; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D062407:Meals / Q000502:physiology; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D007336:Insulin, Isophane; D049528:Insulin, Long-Acting; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; C578220:insulin degludec, insulin aspart drug combination