title: Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes.
abstract: BACKGROUND
  Insulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of the basal analog insulin degludec and the rapid-acting prandial insulin aspart in a single injection. The present combined analysis of two Phase 3a trials compared the incidence of hypoglycemia in participants treated twice daily with IDegAsp or biphasic insulin aspart 30 (BIAsp 30).
  
  
  METHODS
  Hypoglycemia data were analyzed from two similarly designed randomized controlled open-label treat-to-target Phase 3a clinical trials of adults with type 2 diabetes (T2D). Participants were treated twice daily with IDegAsp or BIAsp 30, with breakfast and their main evening meal.
  
  
  RESULTS
  Over 26 weeks, the rates of overall confirmed, nocturnal confirmed and severe hypoglycemic events were 19%, 57%, and 39% lower, respectively, with IDegAsp (n = 504) than BIAsp 30 (n = 364); estimated rate ratios were 0.81 (95% confidence interval [CI] 0.67, 0.98; P = 0.0341), 0.43 (95% CI 0.31, 0.59; P = 0.0001), and 0.61 (95% CI 0.26, 1.45; P = NS). The between-treatment differences were more pronounced during the maintenance period (≥16 weeks); compared with BIAsp 30, rates of overall confirmed, nocturnal confirmed and severe hypoglycemic events with IDegAsp were 0.69 (95% CI 0.55, 0.87; -31%; P = 0.0015); 0.38 (95% CI 0.25, 0.58; -62%; P < 0.0001), and 0.16 (95% CI 0.04, 0.59; -84%; P = 0.0061), respectively.
  
  
  CONCLUSIONS
  Compared with BIAsp 30 twice daily, IDegAsp twice daily provided similar improvements in glycemic control with a lower risk of hypoglycemia, particularly nocturnal hypoglycemia, in subjects with T2D previously treated with insulin.
authors.affiliation: Aarhus University Hospital, Aarhus.
authors.forename: Jens Sandahl
authors.initials: JS
authors.lastname: Christiansen
authors.affiliation: Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
authors.forename: Leo
authors.initials: L
authors.lastname: Niskanen
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Søren
authors.initials: S
authors.lastname: Rasmussen
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Thue
authors.initials: T
authors.lastname: Johansen
authors.affiliation: University of Sydney, Royal North Shore Hospital, Sydney, New South Wales, Australia.
authors.forename: Greg
authors.initials: G
authors.lastname: Fulcher
mesh_terms: D000368:Aged; D061265:Biphasic Insulins / Q000009:adverse effects / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D017326:Clinical Trials, Phase III as Topic; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D061267:Insulin Aspart / Q000009:adverse effects / Q000627:therapeutic use*; D007336:Insulin, Isophane / Q000009:adverse effects / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000009:adverse effects / Q000627:therapeutic use*; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; 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; C571886:insulin degludec
keywords: 2型糖尿病。; b.i.d. treatment; b.i.d.治疗; biphasic insulin aspart 30; hypoglycemia; insulin degludec/insulin aspart; type 2 diabetes; 低血糖; 双相门冬胰岛素30; 德谷胰岛素/门冬胰岛素