ESA-SRB-AOTA 2019

Efficacy and safety of fast-acting insulin aspart compared with insulin aspart, both in combination with insulin degludec, in children and adolescents with type 1 diabetes: the onset 7 trial (#526)

Maria Craig 1 , Bruce Bode 2 , Violeta Iotova 3 , Margarita Kovarenko 4 , Lori Laffel 5 , Paturi V Rao 6 , Henning Andersen 7 , Srikanth Deenadayalan 7 , Steffen Falgreen Larsen 7 , Thomas Danne 8
  1. The Children’s Hospital at Westmead and St George Hospital, Sydney, NSW, Australia
  2. Atlanta Diabetes Associates, Atlanta, Georgia, USA
  3. University Hospital St. Marina, Medical University Varna, Varna, Bulgaria
  4. Pediatric Department, Novosibirsk State Medical University of The Ministry of Healthcare of the Russian Federation, Novosibirsk, Russia
  5. Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA
  6. Diabetes Research Society, Hyderabad, India
  7. Novo Nordisk A/S, Søborg, Denmark
  8. Children's Hospital Auf der Bult, Hannover, Germany

Objectives: To confirm the efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp) in a paediatric sample with type 1 diabetes (T1D).

Methods: A treat-to-target, 26-week, multicentre trial randomised participants (1 to <18 years old) following a 12-week run-in period to double-blind mealtime faster aspart (n=260) or IAsp (n=258), or open-label post-meal faster aspart (n=259), each with daily insulin degludec treatment (NCT02670915). All available information regardless of treatment discontinuation was used for evaluation.

Results: At week 26, non-inferiority (0.4% margin) for the primary endpoint, change from baseline in HbA1c, was confirmed for mealtime and post-meal faster aspart versus IAsp, with a statistically significant difference in favour of mealtime faster aspart (estimated treatment difference [95% CI]: –0.17% [–0.30;–0.03]; –1.82 mmol/mol [–3.28;–0.36]). Change from baseline in 1-hour postprandial glucose significantly favoured mealtime faster aspart versus IAsp at breakfast, lunch and mean over all meals (Figure). No significant differences in overall rate of treatment-emergent severe or blood glucose (BG)-confirmed hypoglycaemic episodes (BG <3.1 mmol/L [56 mg/dL]) were observed. Mean total daily insulin dose on treatment was 0.92 U/kg (mealtime faster aspart), 0.92 U/kg (post-meal faster aspart) and 0.88 U/kg (IAsp).

Conclusion: Mealtime and post-meal faster aspart with insulin degludec provided effective glycaemic control (superior for mealtime faster aspart) versus IAsp, with no additional safety risks in children and adolescents with T1D.

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