Background: Insulin degludec/insulin aspart (IDegAsp) is the first soluble co-formulation that combines two insulin analogues.
Aims and objectives: To assess the efficacy and safety of IDegAsp administered once-daily (OD) plus meal-time IAsp for remaining meals in controlling glycaemia as assessed by change in HbA1c from baseline in a paediatric population.
Methods: A 16-week, 1:1, open-label, parallel group, randomised, treat-to-target trial.
Results: Children aged 15 years (n=82), 611 years (n=122), 1217 years (n=158) with a diabetes duration of 1.66.0 years, HbA1c of 7.98.3% and fasting plasma glucose (FPG) of 8.18.6 mmol/l (all range of means at baseline) were randomised to receive either IDegAsp OD+meal-time IAsp for remaining meals (n=182) or insulin detemir (IDet)+meal-time IAsp (n=180). IDegAsp was non-inferior (limit 0.4%) to IDet for change in HbA1c (estimated treatment difference (ETD) −0.04 (−0.23; 0.15)95%CI), which was accomplished with a numerically lower basal insulin dose: IDegAsp+IAsp: 0.36 vs IDet+IAsp; 0.5 U/kg. ETD for FPG at Week 16 was 0.31 (−0.70; 1.33)95%CI. Rates of confirmed hypoglycaemia were 46.2 (IDegAsp+IAsp) vs 49.6 (IDet+IAsp) events/patient-years of exposure (PYE) (estimated ratio (ER) 0.95 (0.76; 1.17)95%CI). Rates of nocturnal hypoglycaemia were 5.77 (IDegAsp+IAsp) vs 5.40 (IDet+IAsp) events/PYE (ER 1.09 (0.81; 1.48)95%CI). Rates of severe hypoglycaemia were 0.26 (IDegAsp+IAsp) vs 0.07 (IDet+IAsp) events/PYE (ER 3.20 (0.88; 11.66)95%CI; P=ns). Rates of hyperglycaemic episodes with ketosis were 0.11 (IDegAsp+IAsp) vs 0.22 events/PYE (IDegAsp+IAsp) (ER 0.44 (0.11; 1.74)95%CI) and ETD for body weight SD scores was 0.07 (0.02; 0.12)95%CI. Adverse event profiles were similar.
Conclusions: IDegAsp+IAsp was non-inferior to IDet+IAsp for change in HbA1c, at a numerically lower basal insulin dose. There were no significant differences in rates of confirmed or severe hypoglycaemia between IDegAsp+IAsp and IDet+IAsp. IDegAsp+IAsp offers an alternative to basalbolus treatment with one injection of combination insulin per day.
Disclosures: TB has been a board member for Novo Nordisk, Sanofi, Eli Lilly, Medtronic and Bayer Health Care. His institution has received research grants and/or travel and accommodation expenses from Abbott, Medtronic, Novo Nordisk, GluSense, Sanofi, Sandoz and Diamyd. He has served on speakers bureaux for Eli Lilly, Bayer, Novo Nordisk, Medtronic, Sanofi and Roche. He has stock in DreamMed. LD has served on advisory panels for Novo Nordisk, Sanofi and Bayer. He has also received research support from Novo Nordisk and Locemia. PDR and TMG are employees of Novo Nordisk A/S. GK has served as a consultant for Novo Nordisk. M Kocova and M Kovarenko have no conflicts to disclose. NS has served on advisory panels and speakers bureaux for Novo Nordisk.
Conflict of interest: TB has been a board member for Novo Nordisk, Sanofi, Eli Lilly, Medtronic and Bayer Health Care. His institution has received research grants and/or travel and accommodation expenses from Abbott, Medtronic, Novo Nordisk, GluSense, Sanofi, Sandoz and Diamy.
Funding: The work was supported by Novo Nordisk A/S.
01 - 03 Oct 2015
European Society for Paediatric Endocrinology