title: Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3).
abstract: To confirm glycaemic control superiority of mealtime fast-acting insulin aspart (faster aspart) in a basal-bolus (BB) regimen vs basal-only insulin.
  
  
  
  In this open-label, randomized, 18-week trial (51 sites; 6 countries), adults (n = 236) with inadequately controlled type 2 diabetes (T2D; mean glycosylated haemoglobin [HbA1c] ± SD: 7.9% ± 0.7% [63.1 ± 7.5 mmol/mol]) receiving basal insulin and oral antidiabetic drugs underwent 8-week optimization of prior once-daily basal insulin followed by randomization 1:1 to either a BB regimen with faster aspart (n = 116) or continuation of once-daily basal insulin (n = 120), both with metformin. Primary endpoint was HbA1c change from baseline after 18 weeks of treatment. Secondary endpoints included: postprandial plasma glucose (PPG) change and overall PPG increment (all meals); weight; treatment-emergent adverse events; hypoglycaemic episodes.
  
  
  
  HbA1c decreased from 7.9% (63.2 mmol/mol) to 6.8% (50.7 mmol/mol; BB group) and from 7.9% (63.2 mmol/mol) to 7.7% (60.7 mmol/mol; basal-only group); estimated treatment difference [95% confidence interval] -0.94% [-1.17; -0.72]; -10.3 mmol/mol [-12.8; -7.8]; P  < .0001. Reductions from baseline in overall mean 2-hour PPG and overall PPG increment for all meals (self-measured plasma glucose profiles) were statistically significant in favour of BB treatment ( P  < .0001). Severe/blood glucose confirmed hypoglycaemia rate (12.8 vs 2.0 episodes per patient-years of exposure), total daily insulin (1.2 vs 0.6 U/kg) and weight gain (1.8 vs 0.2 kg) were greater with BB than with basal-only treatment.
  
  
  
  In T2D, faster aspart in a BB regimen provided superior glycaemic control as compared with basal-only insulin, but with an increase in the frequency of hypoglycaemia and modest weight gain.
authors.affiliation: Endocrine and Metabolic Consultants, Rockville, Maryland.
authors.forename: Helena W
authors.identifier: 0000-0002-6187-8445
authors.initials: HW
authors.lastname: Rodbard
authors.affiliation: University of Texas Health Science Center, San Antonio, Texas.|Audie L Murphy VA Hospital, San Antonio, Texas.
authors.forename: Devjit
authors.initials: D
authors.lastname: Tripathy
authors.affiliation: Hospital General Regional 110, Guadalajara, Mexico.
authors.forename: Maricela
authors.initials: M
authors.lastname: Vidrio Velázquez
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Marek
authors.initials: M
authors.lastname: Demissie
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Søren C
authors.initials: SC
authors.lastname: Tamer
authors.affiliation: General Hospital, Novo Mesto, Slovenia.
authors.forename: Milivoj
authors.initials: M
authors.lastname: Piletič
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D061267:Insulin Aspart / Q000008:administration & dosage*; D000069057:Insulin Detemir / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D061267:Insulin Aspart; D000069057:Insulin Detemir
keywords: glycaemic control; hypoglycaemia; insulin therapy; phase 3 study; randomized trial; type 2 diabetes