title: Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial.
abstract: BACKGROUND
  The present study was a subgroup analysis of a Pan-Asian Phase 3 open-label randomized treat-to-target trial evaluating insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) in Japanese subjects with type 2 diabetes inadequately controlled on insulin.
  
  
  METHODS
  Eligible subjects (n = 178) were randomized (2: 1) to twice-daily (b.i.d.) IDegAsp or BIAsp 30 with or without metformin for 26 weeks, titrated to a blood glucose target of between 3.9 and <5.0 mmol/L. Changes in HbA1c, the proportion of responders reaching the HbA1ctarget, and changes in fasting plasma glucose, nine-point self-monitored plasma glucose profiles, and body weight were assessed.
  
  
  RESULTS
  At 26 weeks, the decrease in HbA1cwas similar in both groups. Fasting plasma glucose was lower with IDegAsp than BIAsp 30 (estimated treatment difference -1.50 mmol/L; 95 % confidence interval [CI] -1.98, -1.01). Overall confirmed hypoglycemia rates were similar; the nocturnal confirmed hypoglycemia rate was lower with IDegAsp than BIAsp 30 (estimated rate ratio 0.44; 95 % CI 0.20, 0.99). No severe hypoglycemic episodes were reported.
  
  
  CONCLUSIONS
  The results indicate that IDegAsp b.i.d. improves glycemic control and, compared with BIAsp 30, lowers the rate of nocturnal confirmed hypoglycemia.
authors.affiliation: Diabetes Center, Manda Memorial Hospital, Hokkaido, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Taneda
authors.affiliation: Novo Nordisk Pharma Ltd, Tokyo, Japan.
authors.forename: Jacob
authors.initials: J
authors.lastname: Hyllested-Winge
authors.affiliation: Novo Nordisk A/S, Sørborg, Denmark.
authors.forename: Mari-Anne
authors.initials: MA
authors.lastname: Gall
authors.affiliation: Division of Diabetes, Endocrine and Lifestyle-related Disease, Takatsuki Red Cross Hospital, Osaka, Japan.
authors.forename: Shizuka
authors.initials: S
authors.lastname: Kaneko
authors.affiliation: Department of Internal Medicine, HEC Science Clinic, Yokohama, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Hirao
mesh_terms: D000368:Aged; D044466:Asian People; D061265:Biphasic Insulins / Q000009:adverse effects / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D003930:Diabetic Retinopathy / Q000139:chemically induced; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006973:Hypertension / 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*; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D009304:Nasopharyngitis / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D007336:Insulin, Isophane; D049528:Insulin, Long-Acting; D008687:Metformin; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; C571886:insulin degludec
keywords: glycemic control; insulin degludec/insulin aspart; nocturnal hypoglycemia; 血糖控制,德谷胰岛素/门冬胰岛素,夜间低血糖