Cargando…

Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week PRONTO‐T1D study

AIMS: To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26‐week, treat‐to‐target, phase 3 trial. MATERIALS AND METHODS: After an 8‐week lead‐in to optimize basal insulin glargine or degludec, patients were randomized to double‐blind me...

Descripción completa

Detalles Bibliográficos
Autores principales: Klaff, Leslie, Cao, Dachuang, Dellva, Mary Anne, Tobian, Janet, Miura, Junnosuke, Dahl, Dominik, Lucas, Jean, Bue‐Valleskey, Juliana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7539952/
https://www.ncbi.nlm.nih.gov/pubmed/32488923
http://dx.doi.org/10.1111/dom.14100
_version_ 1783591120550232064
author Klaff, Leslie
Cao, Dachuang
Dellva, Mary Anne
Tobian, Janet
Miura, Junnosuke
Dahl, Dominik
Lucas, Jean
Bue‐Valleskey, Juliana
author_facet Klaff, Leslie
Cao, Dachuang
Dellva, Mary Anne
Tobian, Janet
Miura, Junnosuke
Dahl, Dominik
Lucas, Jean
Bue‐Valleskey, Juliana
author_sort Klaff, Leslie
collection PubMed
description AIMS: To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26‐week, treat‐to‐target, phase 3 trial. MATERIALS AND METHODS: After an 8‐week lead‐in to optimize basal insulin glargine or degludec, patients were randomized to double‐blind mealtime URLi (n = 451) or lispro (n = 442), or open‐label post‐meal URLi (n = 329). The primary endpoint was change from baseline glycated haemoglobin (HbA1c) to 26 weeks (non‐inferiority margin 0.4%), with multiplicity‐adjusted objectives for postprandial glucose (PPG) excursions after a meal test. RESULTS: Both mealtime and post‐meal URLi demonstrated non‐inferiority to lispro for HbA1c: estimated treatment difference (ETD) for mealtime URLi −0.08% [95% confidence interval (CI) −0.16, 0.00] and for post‐meal URLi +0.13% (95% CI 0.04, 0.22), with a significantly higher endpoint HbA1c for post‐meal URLi versus lispro (P = 0.003). Mealtime URLi was superior to lispro in reducing 1‐ and 2‐hour PPG excursions during the meal test: ETD −1.55 mmol/L (95% CI −1.96, −1.14) at 1 hour and − 1.73 mmol/L (95% CI −2.28, −1.18) at 2 hours (both P < 0.001). The rate and incidence of severe, documented and postprandial hypoglycaemia (<3.0 mmol/L) was similar between treatments, but mealtime URLi demonstrated a 37% lower rate in the period >4 hours after meals (P = 0.013). Injection site reactions were reported by 2.9% of patients on mealtime URLi, 2.4% on post‐meal URLi, and 0.2% on lispro. Overall, the incidence of treatment‐emergent adverse events was similar between treatments. CONCLUSIONS: The results showed that URLi provided good glycaemic control, with non‐inferiority to lispro confirmed for both mealtime and post‐meal URLi, while superior PPG control was demonstrated with mealtime dosing.
format Online
Article
Text
id pubmed-7539952
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Blackwell Publishing Ltd
record_format MEDLINE/PubMed
spelling pubmed-75399522020-10-09 Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week PRONTO‐T1D study Klaff, Leslie Cao, Dachuang Dellva, Mary Anne Tobian, Janet Miura, Junnosuke Dahl, Dominik Lucas, Jean Bue‐Valleskey, Juliana Diabetes Obes Metab Original Articles AIMS: To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26‐week, treat‐to‐target, phase 3 trial. MATERIALS AND METHODS: After an 8‐week lead‐in to optimize basal insulin glargine or degludec, patients were randomized to double‐blind mealtime URLi (n = 451) or lispro (n = 442), or open‐label post‐meal URLi (n = 329). The primary endpoint was change from baseline glycated haemoglobin (HbA1c) to 26 weeks (non‐inferiority margin 0.4%), with multiplicity‐adjusted objectives for postprandial glucose (PPG) excursions after a meal test. RESULTS: Both mealtime and post‐meal URLi demonstrated non‐inferiority to lispro for HbA1c: estimated treatment difference (ETD) for mealtime URLi −0.08% [95% confidence interval (CI) −0.16, 0.00] and for post‐meal URLi +0.13% (95% CI 0.04, 0.22), with a significantly higher endpoint HbA1c for post‐meal URLi versus lispro (P = 0.003). Mealtime URLi was superior to lispro in reducing 1‐ and 2‐hour PPG excursions during the meal test: ETD −1.55 mmol/L (95% CI −1.96, −1.14) at 1 hour and − 1.73 mmol/L (95% CI −2.28, −1.18) at 2 hours (both P < 0.001). The rate and incidence of severe, documented and postprandial hypoglycaemia (<3.0 mmol/L) was similar between treatments, but mealtime URLi demonstrated a 37% lower rate in the period >4 hours after meals (P = 0.013). Injection site reactions were reported by 2.9% of patients on mealtime URLi, 2.4% on post‐meal URLi, and 0.2% on lispro. Overall, the incidence of treatment‐emergent adverse events was similar between treatments. CONCLUSIONS: The results showed that URLi provided good glycaemic control, with non‐inferiority to lispro confirmed for both mealtime and post‐meal URLi, while superior PPG control was demonstrated with mealtime dosing. Blackwell Publishing Ltd 2020-06-28 2020-10 /pmc/articles/PMC7539952/ /pubmed/32488923 http://dx.doi.org/10.1111/dom.14100 Text en © 2020 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Klaff, Leslie
Cao, Dachuang
Dellva, Mary Anne
Tobian, Janet
Miura, Junnosuke
Dahl, Dominik
Lucas, Jean
Bue‐Valleskey, Juliana
Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week PRONTO‐T1D study
title Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week PRONTO‐T1D study
title_full Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week PRONTO‐T1D study
title_fullStr Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week PRONTO‐T1D study
title_full_unstemmed Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week PRONTO‐T1D study
title_short Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week PRONTO‐T1D study
title_sort ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: results from the 26‐week pronto‐t1d study
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7539952/
https://www.ncbi.nlm.nih.gov/pubmed/32488923
http://dx.doi.org/10.1111/dom.14100
work_keys_str_mv AT klaffleslie ultrarapidlisproimprovespostprandialglucosecontrolcomparedwithlisproinpatientswithtype1diabetesresultsfromthe26weekprontot1dstudy
AT caodachuang ultrarapidlisproimprovespostprandialglucosecontrolcomparedwithlisproinpatientswithtype1diabetesresultsfromthe26weekprontot1dstudy
AT dellvamaryanne ultrarapidlisproimprovespostprandialglucosecontrolcomparedwithlisproinpatientswithtype1diabetesresultsfromthe26weekprontot1dstudy
AT tobianjanet ultrarapidlisproimprovespostprandialglucosecontrolcomparedwithlisproinpatientswithtype1diabetesresultsfromthe26weekprontot1dstudy
AT miurajunnosuke ultrarapidlisproimprovespostprandialglucosecontrolcomparedwithlisproinpatientswithtype1diabetesresultsfromthe26weekprontot1dstudy
AT dahldominik ultrarapidlisproimprovespostprandialglucosecontrolcomparedwithlisproinpatientswithtype1diabetesresultsfromthe26weekprontot1dstudy
AT lucasjean ultrarapidlisproimprovespostprandialglucosecontrolcomparedwithlisproinpatientswithtype1diabetesresultsfromthe26weekprontot1dstudy
AT buevalleskeyjuliana ultrarapidlisproimprovespostprandialglucosecontrolcomparedwithlisproinpatientswithtype1diabetesresultsfromthe26weekprontot1dstudy