title: Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial.
abstract: OBJECTIVE
  This phase 3, 26-week, open-label, treat-to-target trial investigated the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in insulin-naïve Japanese adults with type 2 diabetes.
  
  
  METHODS
  Subjects were randomized to once-daily injections of IDegAsp (n = 147) or insulin glargine (IGlar) (n = 149), both ±≤2 oral antidiabetic treatments. IDegAsp was given before the largest meal at the discretion of each subject (and maintained throughout the trial); IGlar was dosed according to label. Both insulins were titrated to a target prebreakfast self-measured plasma glucose of 3.9 to <5.0 mmol/l.
  
  
  RESULTS
  After 26 weeks, mean HbA1c was 7% with IDegAsp and 7.3% with IGlar; superiority of IDegAsp to IGlar was shown (estimated treatment difference, ETD; IDegAsp-IGlar: -0.28% points [-0.46; -0.10](95% CI), p < 0.01). At end-of-trial, mean fasting plasma glucose (FPG) was similar for IDegAsp and IGlar (5.7 vs. 5.6 mmol/l; ETD IDegAsp-IGlar: 0.15 mmol/l [-0.29; 0.60](95% CI), p = NS). IDegAsp was associated with numerically lower rates of overall confirmed (27%) and nocturnal confirmed hypoglycaemia (25%) versus IGlar (estimated rate ratio IDegAsp/IGlar: 0.73 [0.50; 1.08](95% CI), p = NS, and 0.75 [0.34; 1.64](95% CI), p = NS, respectively). Mean daily insulin doses were similar between groups at end-of-trial (both: 0.41 U/kg) as were the increases in body weight from baseline (both: 0.7 kg). Adverse event profiles were similar between groups.
  
  
  CONCLUSIONS
  IDegAsp provided superior long-term glycaemic control compared to IGlar, with similar FPG and doses and numerically lower rates of overall and nocturnal hypoglycaemia (p = NS).
authors.affiliation: The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Onishi
authors.forename: Y
authors.initials: Y
authors.lastname: Ono
authors.forename: R
authors.initials: R
authors.lastname: Rabøl
authors.forename: L
authors.initials: L
authors.lastname: Endahl
authors.forename: S
authors.initials: S
authors.lastname: Nakamura
mesh_terms: D000328:Adult; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; 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
keywords: diabetes mellitus; glycaemic control; insulin analogues; insulin therapy; phase 3 study