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Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial

AIMS: To investigate the safety and tolerability of 5 and 10 mg dapagliflozin added to insulin therapy over 52 weeks in Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: This randomized, open‐label, parallel‐group, multicentre phase III clinical t...

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Autores principales: Araki, Eiichi, Watada, Hirotaka, Uchigata, Yasuko, Tomonaga, Osamu, Fujii, Hitomi, Ohashi, Hiroshi, Okabe, Tadashi, Asano, Michiko, Thoren, Fredrik, Kim, Hyosung, Yajima, Toshitaka, Langkilde, Anna Maria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7078973/
https://www.ncbi.nlm.nih.gov/pubmed/31742898
http://dx.doi.org/10.1111/dom.13922
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author Araki, Eiichi
Watada, Hirotaka
Uchigata, Yasuko
Tomonaga, Osamu
Fujii, Hitomi
Ohashi, Hiroshi
Okabe, Tadashi
Asano, Michiko
Thoren, Fredrik
Kim, Hyosung
Yajima, Toshitaka
Langkilde, Anna Maria
author_facet Araki, Eiichi
Watada, Hirotaka
Uchigata, Yasuko
Tomonaga, Osamu
Fujii, Hitomi
Ohashi, Hiroshi
Okabe, Tadashi
Asano, Michiko
Thoren, Fredrik
Kim, Hyosung
Yajima, Toshitaka
Langkilde, Anna Maria
author_sort Araki, Eiichi
collection PubMed
description AIMS: To investigate the safety and tolerability of 5 and 10 mg dapagliflozin added to insulin therapy over 52 weeks in Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: This randomized, open‐label, parallel‐group, multicentre phase III clinical trial was conducted from October 26, 2015 to June 15, 2017. The primary endpoint was the occurrence of adverse events such as hypoglycaemia and diabetic ketoacidosis. Secondary endpoints included changes in glycaemic parameters, total daily insulin dosage and body weight over time. The efficacy of dapagliflozin in patients stratified by body mass index (BMI) <25.0 and ≥25.0 kg/m(2) was evaluated in a subgroup analysis. RESULTS: In total, 151 patients received 5 mg (n = 76) or 10 mg (n = 75) dapagliflozin once daily for 52 weeks. Adverse events were observed in 88.2% and 73.3% of patients in the 5 and 10 mg dapagliflozin groups, respectively. Severe hypoglycaemia was reported in 2.6% (n = 2) and 6.7% (n = 5) of patients, and diabetic ketoacidosis in 2.6% (n = 2) and 1.3% (n = 1) of patients in the 5 and 10 mg dapagliflozin groups, respectively. The adjusted mean (95% confidence interval) changes in glycated haemoglobin at week 52 were −0.33% (−0.50, −0.15) and −0.36% (−0.53, −0.18) in the 5 and 10 mg dapagliflozin groups, respectively. There were no differences in efficacy parameters when stratified by BMI. CONCLUSIONS: This study demonstrated the long‐term safety and tolerability of dapagliflozin added to insulin therapy in Japanese patients with inadequately controlled T1DM.
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spelling pubmed-70789732020-03-19 Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial Araki, Eiichi Watada, Hirotaka Uchigata, Yasuko Tomonaga, Osamu Fujii, Hitomi Ohashi, Hiroshi Okabe, Tadashi Asano, Michiko Thoren, Fredrik Kim, Hyosung Yajima, Toshitaka Langkilde, Anna Maria Diabetes Obes Metab Original Articles AIMS: To investigate the safety and tolerability of 5 and 10 mg dapagliflozin added to insulin therapy over 52 weeks in Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: This randomized, open‐label, parallel‐group, multicentre phase III clinical trial was conducted from October 26, 2015 to June 15, 2017. The primary endpoint was the occurrence of adverse events such as hypoglycaemia and diabetic ketoacidosis. Secondary endpoints included changes in glycaemic parameters, total daily insulin dosage and body weight over time. The efficacy of dapagliflozin in patients stratified by body mass index (BMI) <25.0 and ≥25.0 kg/m(2) was evaluated in a subgroup analysis. RESULTS: In total, 151 patients received 5 mg (n = 76) or 10 mg (n = 75) dapagliflozin once daily for 52 weeks. Adverse events were observed in 88.2% and 73.3% of patients in the 5 and 10 mg dapagliflozin groups, respectively. Severe hypoglycaemia was reported in 2.6% (n = 2) and 6.7% (n = 5) of patients, and diabetic ketoacidosis in 2.6% (n = 2) and 1.3% (n = 1) of patients in the 5 and 10 mg dapagliflozin groups, respectively. The adjusted mean (95% confidence interval) changes in glycated haemoglobin at week 52 were −0.33% (−0.50, −0.15) and −0.36% (−0.53, −0.18) in the 5 and 10 mg dapagliflozin groups, respectively. There were no differences in efficacy parameters when stratified by BMI. CONCLUSIONS: This study demonstrated the long‐term safety and tolerability of dapagliflozin added to insulin therapy in Japanese patients with inadequately controlled T1DM. Blackwell Publishing Ltd 2019-12-26 2020-04 /pmc/articles/PMC7078973/ /pubmed/31742898 http://dx.doi.org/10.1111/dom.13922 Text en © 2019 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/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 Original Articles
Araki, Eiichi
Watada, Hirotaka
Uchigata, Yasuko
Tomonaga, Osamu
Fujii, Hitomi
Ohashi, Hiroshi
Okabe, Tadashi
Asano, Michiko
Thoren, Fredrik
Kim, Hyosung
Yajima, Toshitaka
Langkilde, Anna Maria
Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial
title Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial
title_full Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial
title_fullStr Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial
title_full_unstemmed Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial
title_short Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial
title_sort efficacy and safety of dapagliflozin in japanese patients with inadequately controlled type 1 diabetes (depict‐5): 52‐week results from a randomized, open‐label, phase iii clinical trial
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7078973/
https://www.ncbi.nlm.nih.gov/pubmed/31742898
http://dx.doi.org/10.1111/dom.13922
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