title: Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: a 26-week, randomised, treat-to-target trial.
abstract: OBJECTIVE
  Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of IDeg and IAsp. This pan-Asian, 26-week trial investigated efficacy and safety of IDegAsp vs biphasic insulin aspart 30 (BIAsp 30) in Asian adults with type 2 diabetes (T2DM), inadequately controlled on once- or twice-daily (BID) basal, premixed or self-mixed insulin.
  
  
  METHODS
  Participants (mean age 59.8 years, HbA1c 8.4%, FPG 7.9 mmol/L, BMI 25.4 kg/m(2)) were randomised 2:1 to BID IDegAsp (n=282) or BIAsp 30 (n=142) and continued existing metformin treatment. Insulins were administered with breakfast and main evening meal, titrated to a pre-breakfast and pre-main evening meal self-measured plasma glucose target of 4-5 mmol/L.
  
  
  RESULTS
  IDegAsp achieved the primary endpoint of non-inferiority to BIAsp 30 for mean change in HbA₁c (estimated treatment difference [ETD] IDegAsp-BIAsp 30: 0.05% points [95% CI -0.10; 0.20]). IDegAsp was superior in lowering fasting plasma glucose (FPG) (ETD -1.06 mmol/L, 95% CI -1.43; -0.70, p<0.001), and resulted in a lower final mean daily insulin dose (0.79 U/kg vs 0.99 U/kg, estimated rate ratio [RR] 0.79, 95% CI 0.73; 0.85, p<0.0001). Rates of overall confirmed and severe hypoglycaemia were similar between treatments, while rate of nocturnal confirmed hypoglycaemia was numerically (p=ns) lower with IDegAsp. During the maintenance period there was a trend (p=ns) towards lower hypoglycaemia rates for IDegAsp.
  
  
  CONCLUSIONS
  In Asian adults with T2DM, IDegAsp BID effectively improves long-term glycaemic control, and compared to BIAsp 30, provides superior reductions in FPG with a lower dose, and numerically less nocturnal hypoglycaemia.
authors.affiliation: Takatsuki Red Cross Hospital, Abuno 1-1-1, Ōsaka, Japan.
authors.forename: Shizuka
authors.initials: S
authors.lastname: Kaneko
authors.affiliation: Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.
authors.forename: Francis
authors.initials: F
authors.lastname: Chow
authors.affiliation: Department of Internal Medicine, Korea University Anam Hospital, 126-1,5-ka,Anam-Dong, Seoul, South Korea.
authors.forename: Dong Seop
authors.initials: DS
authors.lastname: Choi
authors.affiliation: Diabetes Center, Manda Memorial Hospital, 1-1, Minami Nijo, Sapporo, Hokkaido, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Taneda
authors.affiliation: Department of Internal Medicine, H.E.C Science Clinic, 4-1-4-102, Yokodai, Yokohama-shi, Kanagawa, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Hirao
authors.affiliation: Department of Internal Medicine and Bioengineering, Hanyang University Hospital, Seoul 133-791, South Korea.
authors.forename: Yongsoo
authors.initials: Y
authors.lastname: Park
authors.affiliation: Global Medical Affairs-Insulin, Novo Nordisk A/S, Vandtårnsvej 114, Søborg, Denmark.
authors.forename: Thomas Hasseriis
authors.initials: TH
authors.lastname: Andersen
authors.affiliation: Global Development, Novo Nordisk A/S, Vandtårnsvej 114, Søborg, Denmark.
authors.forename: Mari-Anne
authors.initials: MA
authors.lastname: Gall
authors.affiliation: Department of Endocrinology MEA, Aarhus University Hospital, Dk-8000 Aarhus C, Denmark. Electronic address: jsc@ki.au.dk.
authors.forename: Jens Sandahl
authors.initials: JS
authors.lastname: Christiansen
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People / Q000706:statistics & numerical data; D061265:Biphasic Insulins / Q000627:therapeutic use*; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D004338:Drug Combinations; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D061267:Insulin Aspart / Q000627:therapeutic use*; D000069057:Insulin Detemir; D007336:Insulin, Isophane / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D017211:Treatment Failure
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart; D000069057:Insulin Detemir; D007336:Insulin, Isophane; D049528:Insulin, Long-Acting; D008687:Metformin; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; C578220:insulin degludec, insulin aspart drug combination
keywords: HbA(1c); Insulin aspart; Insulin degludec; Type 2 diabetes