Full results from onset 1 and onset 2 - the phase 3a trials assessing the use of faster-acting insulin aspart in people with type 1 diabetes (onset 1) and type 2 diabetes (onset 2) - were presented at the 76th annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, LA, USA. In type 1 patients, findings show that adults treated with faster-acting insulin aspart had significantly reduced HbA1c and improved postprandial glucose (PPG) control after 2-hours when compared with NovoRapid® (insulin aspart) in a basal-bolus regimen1. In type 2 patients, HbA1c reduction was comparable and PPG was improved after 1-hour, but not after 2- hours with faster-acting insulin aspart, versus insulin aspart in a basal-bolus regimen2.

In onset 1, after 26 weeks of randomised therapy, faster-acting insulin aspart showed1:

  • Significant HbA1c reduction versus insulin aspart in adults with type 1 diabetes when dosed at mealtime (95% confidence interval [CI] -0.15 [-0.23; -0.07])
  • Comparable HbA1c reduction when dosed 20 minutes after starting a meal compared with insulin aspart dosed at mealtime (95% CI 0.04 [-0.04; 0.12])
  • Superior reduction in the rise of 2-hour PPG (95% CI -0.67 [-1.29; -0.04] mmol/L) versus insulin aspart
  • A reduction in the 1-hour PPG increment* (95% CI -1.18 [-1.65; -0.71] mmol/L), a secondary supportive endpoint

In onset 2, faster-acting insulin aspart showed2:

  • Comparable reduction versus insulin aspart in reducing HbA1c in adults with type 2 diabetes (95% CI -0.02 [-0.15; 0.10])
  • A reduction in the 1-hour PPG increment* (95% CI -0.59 [-1.09; -0.09] mmol/L), a secondary supportive endpoint
  • No significant reduction in the rise of 2-hour PPG (95% CI -0.36 [-0.81; 0.08] mmol/L)

"Improving PPG control is important in achieving HbA1c targets for patients with type 1 or type 2 diabetes. Poor control of PPG can often result in post-meal hyperglycaemia, which can have a wide-range of negative effects on patients", explained Professor David Russell-Jones, primary investigator for onset 1, Consultant Physician at the Royal Surrey County Hospital, and Professor of Diabetes and Endocrinology at the University of Surrey. "The results from onset 1 and onset 2 showed that faster-acting insulin aspart improved PPG control compared with insulin aspart; HbA1c outcomes were also significantly improved in type 1 patients and non-inferior in type 2 patients. Of particular interest was the finding that post-meal dosing of faster-acting insulin aspart was as effective as pre- meal dosing of insulin aspart in patients with type 1 diabetes, which highlights the potential physiological and lifestyle advantages of this faster insulin formulation."

In both trials, the previously reported safety and tolerability profiles of faster-acting insulin aspart and insulin aspart were confirmed. No apparent differences were identified between the two treatment groups with respect to adverse events and other safety parameters. The most commonly reported adverse event associated with faster-acting insulin aspart in the onset 1 and onset 2 studies was hypoglycaemia. No significant difference in the overall rate of severe or confirmed hypoglycaemia in people with type 1 or type 2 diabetes was identified between faster-acting insulin aspart and insulin aspart.1,2