ESA-SRB-AOTA 2019

Hypoglycaemia with mealtime fast-acting insulin aspart versus insulin aspart across two large type 1 diabetes trials (#546)

David O'Neal 1 , Christophe De Block 2 , Anders Carlson 3 , Ludger Rose 4 , Theis Gondolf 5 , Anders Gorst-Rasmussen 5 , Wendy Lane 6
  1. University of Melbourne Department of Medicine, St Vincent’s Hospital, Melbourne, Victoria, Australia
  2. Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital, Antwerp, Belgium
  3. International Diabetes Center, Minneapolis, Minnesota, USA
  4. Institute for Diabetes Research, Münster, Germany
  5. Novo Nordisk A/S, Søborg, Denmark
  6. Mountain Diabetes and Endocrine Center, Asheville, North Carolina, USA

Hypoglycaemia is a ubiquitous challenge with insulin treatment in type 1 diabetes (T1D), with nocturnal episodes of particular concern. Severe (as defined by the American Diabetes Association) or blood glucose-confirmed (<56 mg/dL [3.1 mmol/L]) hypoglycaemia was investigated across two double-blind, treat-to-target, randomised trials assessing the efficacy and safety of mealtime fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp) by multiple daily injections in adults with T1D: a 52-week trial in combination with insulin detemir (onset 1; n=761), and a 26-week trial in combination with insulin degludec (onset 8; n=684). Faster aspart was confirmed to be non-inferior to IAsp regarding change from baseline in HbA1c in both trials, with a statistically significantly greater HbA1c reduction with faster aspart in onset 1. Importantly, nocturnal hypoglycaemia rates were consistently lower with faster aspart versus IAsp in both trials (pooled estimated treatment rate ratio [ETR] 0.84 [95% CI 0.72;0.98]; p=0.02) (Figure), while no significant difference was observed for overall (pooled ETR 0.94 [95% CI: 0.85;1.05]) and diurnal hypoglycaemia (pooled ETR 0.96 [95% CI 0.86;1.07]) (Figure) with some heterogeneity across trials. In summary, analysis across two large trials supports the safety of mealtime faster aspart, with lower rates of nocturnal hypoglycaemia with faster aspart versus IAsp.

ClinicalTrials.gov: NCT01831765; NCT02500706

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