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Faster-acting insulin aspart non-superior to aspart in pump therapy

Devices – April 2019 digest

Onset 5 study evaluating the efficacy and safety of fast-acting insulin aspart administered by pump to people with type 1 diabetes.

Klonoff DC, Evans ML, Lane W et al (2019) A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab 21: 961–7

  • Insulin pump therapy can improve glycaemic control and reduce the risk of hypoglycaemia in people with type 1 diabetes; however, as only about a third of these individuals achieve a target HbA1c of <53 mmol/mol (<7%), there is a need to develop insulins with actions that more closely resemble physiological insulin in addition to using modern insulin delivery and monitoring systems.
  • Onset 5 aimed to evaluate the safety and efficacy of fast-acting insulin aspart (Fiasp) compared to insulin aspart when administered via pump therapy in people with type 1 diabetes.
  • A total of 472 participants were randomised to Fiasp or insulin aspart for 16 weeks to compare their effects on baseline HbA1c (the primary endpoint). A bolus was administered at the start of each meal and change in post-prandial glucose was measured.
  • Sixteen weeks after randomisation, researchers found that baseline HbA1c had dropped from 61.7 mmol/mol (7.8%) in both arms at the start of the trial to 57.8 mmol/mol (7.44%) in the Fiasp group and 56.8 mmol/mol (7.35%) in the insulin aspart group. Fiasp resulted in a greater 1-hour post-prandial glucose change as well as a greater risk of severe hypoglycaemia within an hour of receiving the mealtime bolus. 
  • Researchers declared Fiasp to be non-inferior to insulin aspart. No significant difference was found in the proportion of participants achieving target HbA1c. They concluded that the drop in post-prandial glucose levels reflected the faster onset of action and early glucose-lowering effect of Fiasp.
  • Fiasp led to a superior post-prandial glucose reduction compared to insulin aspart and was found to be safe and effective for administration via pump in people with type 1 diabetes. 

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