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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

BACKGROUND: Historically, data on the rate of hyperglycemia and ketosis have not been collected in clinical trials. However, it is clinically important to assess the rate of these events in children with type 1 diabetes (T1D). This question was addressed in two pediatric trials using insulin deglude...

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Autores principales: Thalange, Nandu, Deeb, Larry, Klingensmith, Georgeanna, Franco, Denise R., Bardtrum, Lars, Tutkunkardas, Deniz, Danne, Thomas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons A/S 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6849556/
https://www.ncbi.nlm.nih.gov/pubmed/30666772
http://dx.doi.org/10.1111/pedi.12821
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author Thalange, Nandu
Deeb, Larry
Klingensmith, Georgeanna
Franco, Denise R.
Bardtrum, Lars
Tutkunkardas, Deniz
Danne, Thomas
author_facet Thalange, Nandu
Deeb, Larry
Klingensmith, Georgeanna
Franco, Denise R.
Bardtrum, Lars
Tutkunkardas, Deniz
Danne, Thomas
author_sort Thalange, Nandu
collection PubMed
description BACKGROUND: Historically, data on the rate of hyperglycemia and ketosis have not been collected in clinical trials. However, it is clinically important to assess the rate of these events in children with type 1 diabetes (T1D). This question was addressed in two pediatric trials using insulin degludec (degludec). OBJECTIVE: To assess the rate of hyperglycemia and ketosis in two‐phase 3b trials investigating degludec (Study 1) and degludec with insulin aspart (IDegAsp [Study 2]) vs insulin detemir (IDet). SUBJECTS: Patients (aged 1‐17 years inclusive) with T1D treated with insulin for ≥3 months. METHODS: Study 1: patients were randomized to degludec once daily (OD) or IDet OD/twice daily (BID) for 26 weeks, followed by a 26‐week extension phase. Study 2: patients were randomized to IDegAsp OD or IDet OD/BID for 16 weeks. Bolus mealtime IAsp was included in both studies. In Study 1, hyperglycemia was recorded if plasma glucose (PG) was >11.1 mmol/L, with ketone measurement required with significant hyperglycemia (>14.0 mmol/L). In Study 2, hyperglycemia was recorded with PG >14.0 mmol/L where the subject looked/felt ill, with ketone measurement also required in these hyperglycemic patients. In this post hoc analysis, the hyperglycemia threshold was 14.0 mmol/L for uniformity. RESULTS: Despite similar rates of hyperglycemia with degludec/IDegAsp compared with IDet, the rates of ketosis were lower with degludec/IDegAsp. CONCLUSIONS: These trials, the first to systematically collect data on ketosis in pediatric patients with T1D, demonstrate the potential of degludec/IDegAsp to reduce rates of metabolic decompensation, compared with IDet.
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spelling pubmed-68495562019-11-15 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 Thalange, Nandu Deeb, Larry Klingensmith, Georgeanna Franco, Denise R. Bardtrum, Lars Tutkunkardas, Deniz Danne, Thomas Pediatr Diabetes Clinical Care and Technology BACKGROUND: Historically, data on the rate of hyperglycemia and ketosis have not been collected in clinical trials. However, it is clinically important to assess the rate of these events in children with type 1 diabetes (T1D). This question was addressed in two pediatric trials using insulin degludec (degludec). OBJECTIVE: To assess the rate of hyperglycemia and ketosis in two‐phase 3b trials investigating degludec (Study 1) and degludec with insulin aspart (IDegAsp [Study 2]) vs insulin detemir (IDet). SUBJECTS: Patients (aged 1‐17 years inclusive) with T1D treated with insulin for ≥3 months. METHODS: Study 1: patients were randomized to degludec once daily (OD) or IDet OD/twice daily (BID) for 26 weeks, followed by a 26‐week extension phase. Study 2: patients were randomized to IDegAsp OD or IDet OD/BID for 16 weeks. Bolus mealtime IAsp was included in both studies. In Study 1, hyperglycemia was recorded if plasma glucose (PG) was >11.1 mmol/L, with ketone measurement required with significant hyperglycemia (>14.0 mmol/L). In Study 2, hyperglycemia was recorded with PG >14.0 mmol/L where the subject looked/felt ill, with ketone measurement also required in these hyperglycemic patients. In this post hoc analysis, the hyperglycemia threshold was 14.0 mmol/L for uniformity. RESULTS: Despite similar rates of hyperglycemia with degludec/IDegAsp compared with IDet, the rates of ketosis were lower with degludec/IDegAsp. CONCLUSIONS: These trials, the first to systematically collect data on ketosis in pediatric patients with T1D, demonstrate the potential of degludec/IDegAsp to reduce rates of metabolic decompensation, compared with IDet. John Wiley & Sons A/S 2019-02-10 2019-05 /pmc/articles/PMC6849556/ /pubmed/30666772 http://dx.doi.org/10.1111/pedi.12821 Text en © 2019 The Authors. Pediatric Diabetes published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Clinical Care and Technology
Thalange, Nandu
Deeb, Larry
Klingensmith, Georgeanna
Franco, Denise R.
Bardtrum, Lars
Tutkunkardas, Deniz
Danne, Thomas
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Clinical Care and Technology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6849556/
https://www.ncbi.nlm.nih.gov/pubmed/30666772
http://dx.doi.org/10.1111/pedi.12821
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