title: Efficacy and Safety of Once-Daily Insulin Degludec/Insulin Aspart versus Insulin Glargine (U100) for 52 Weeks in Insulin-Naïve Patients with Type 2 Diabetes: A Randomized Controlled Trial.
abstract: OBJECTIVE
  The efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily (OD) compared with insulin glargine U100 (IGlar) OD over 52 weeks in insulin-naïve adults with type 2 diabetes mellitus (T2DM) was investigated.
  
  
  METHODS
  In this open-label, parallel-group treat-to-target trial, participants were randomized (1:1) to receive IDegAsp OD (breakfast, n = 266) or IGlar OD (as per label, n = 264). Participants then entered a 26-week extension phase (IDegAsp OD, n = 192; IGlar OD, n = 221). The primary endpoint was change from baseline to Week 26 in HbA1c.
  
  
  RESULTS
  After 26 and 52 weeks, mean HbA1c decreased to similar levels in both groups. After 52 weeks, the mean estimated treatment difference was -0.08% (-0.26, 0.09 95%CI), confirming the non-inferiority of IDegAsp OD versus IGlar OD evaluated at Week 26. After 52 weeks, there was a similar reduction in mean fasting plasma glucose in both treatment groups. The rate of confirmed hypoglycemic episodes was 86% higher (p < 0.0001) whereas the rate of nocturnal hypoglycemia was 75% lower (p < 0.0001) for IDegAsp versus IGlar.
  
  
  CONCLUSIONS
  Nocturnal-confirmed hypoglycemia was higher with IGlar whereas overall and diurnal hypoglycemia were higher with IDegAsp dosed at breakfast. These results highlight the importance of administration of IDegAsp with the main meal of the day, tailored to the individual patient's needs.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01045707 [core]) and NCT01169766 [ext].
authors.affiliation: Diabetes Care & Research Centre, Near Overbridge, Kankarbagh, Patna, Bihar, India.
authors.forename: Ajay
authors.initials: A
authors.lastname: Kumar
authors.affiliation: Medical Research Center, Polish Academy of Sciences and Central Clinical Hospital MSWiA, Warsaw, Poland.
authors.forename: Edward
authors.initials: E
authors.lastname: Franek
authors.affiliation: Tulane Medical School, Department of Endocrinology, New Orleans, LA, United States of America.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Wise
authors.affiliation: Market Access and Public Affairs, Novo Nordisk Pharma GmbH, Mainz, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Niemeyer
authors.affiliation: Clinical Development & Research-Diabetes & Obesity, Novo Nordisk Inc, Princeton, NJ, United States of America.
authors.forename: Henriette
authors.initials: H
authors.lastname: Mersebach
authors.affiliation: Diabetes and Metabolism Research Unit, Autonomous University of Barcelona, Vall d'Hebron Institute de Recerca, and CIBERDEM, Barcelona, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Simó
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000069036:Insulin Glargine / Q000009:adverse effects* / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012449:Safety
chemical_list: D001786:Blood Glucose; D004338:Drug Combinations; D049528:Insulin, Long-Acting; C578220:insulin degludec, insulin aspart drug combination; D000069036:Insulin Glargine