The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials
Pediatric Diabetes Feb 17, 2019
Thalange N, et al. - Researchers evaluated the rate of hyperglycemia and ketosis in studies of degludec (study 1) and degludec with insulin aspart (IDegAsp [Study 2]) vs insulin detemir (IDet) in two-phase 3b trials. The study sample consisted of patients (aged 1-17 years inclusive) with type 1 diabetes (T1D) treated with insulin for ≥3 months. For 26 weeks, patients were randomized to degludec once daily (OD) or IDet OD/twice daily (BID), followed by an extension period of 26 weeks in study 1. For 16 weeks, patients have been randomized to IDegAsp OD or IDet OD/BID in study 2. In pediatric patients with T1D, the two studies reported here are the first to systematically collect data on ketone levels. These data show the potential of degludec/IDegAsp to reduce the rate of ketosis and metabolic decompensation in children with T1D in comparison with IDet. Most of the adverse events reported in Studies 1 and 2 for both groups were mild or moderate in severity and were considered unlikely to be related to the trial product.
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