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...
Autores principales: | , , , , , , , |
---|---|
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 |