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Long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT‐2 study
AIM: To examine the long‐term efficacy and safety of dapagliflozin, a sodium‐glucose co‐transporter‐2 (SGLT2) inhibitor used to treat type 1 diabetes, in the Japanese subpopulation of the DEPICT‐2 study. MATERIALS AND METHODS: Patients with type 1 diabetes were randomized to dapagliflozin 5 mg (n =...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251623/ https://www.ncbi.nlm.nih.gov/pubmed/33620762 http://dx.doi.org/10.1111/dom.14362 |
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author | Araki, Eiichi Mathieu, Chantal Shiraiwa, Toshihiko Maeda, Hajime Ikeda, Hiroki Thoren, Fredrik Arya, Niki Asano, Michiko Iqbal, Nayyar |
author_facet | Araki, Eiichi Mathieu, Chantal Shiraiwa, Toshihiko Maeda, Hajime Ikeda, Hiroki Thoren, Fredrik Arya, Niki Asano, Michiko Iqbal, Nayyar |
author_sort | Araki, Eiichi |
collection | PubMed |
description | AIM: To examine the long‐term efficacy and safety of dapagliflozin, a sodium‐glucose co‐transporter‐2 (SGLT2) inhibitor used to treat type 1 diabetes, in the Japanese subpopulation of the DEPICT‐2 study. MATERIALS AND METHODS: Patients with type 1 diabetes were randomized to dapagliflozin 5 mg (n = 55), dapagliflozin 10 mg (n = 41) or placebo (n = 58) plus insulin for a 24‐week, double‐blind period followed by a 28‐week, single‐blind extension phase. RESULTS: From baseline to 24 weeks, dapagliflozin reduced HbA1c compared with placebo (mean change of −0.58% and −0.80% for 5 and 10 mg, respectively), and an HbA1c reduction was observed up to 52 weeks. Compared with placebo, dapagliflozin 5 and 10 mg increased the proportion of patients achieving HbA1c reductions of 0.5% or more without severe hypoglycaemia events and reduced glycaemic variability assessed via continuous glucose monitoring. Both dapagliflozin doses decreased body weight and total daily insulin dose at 24 weeks compared with placebo; these reductions were maintained up to 52 weeks. Diabetic ketoacidosis occurred in both dapagliflozin groups (one and two cases, respectively) but not with placebo. CONCLUSIONS: Efficacy and safety results from the Japanese subpopulation of the DEPICT‐2 study were generally consistent with those from the overall population, indicating that long‐term dapagliflozin adjunct to insulin therapy improves glycaemic control without an increased risk of hypoglycaemia but with a risk of diabetic ketoacidosis in Japanese patients with type 1 diabetes. |
format | Online Article Text |
id | pubmed-8251623 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-82516232021-07-06 Long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT‐2 study Araki, Eiichi Mathieu, Chantal Shiraiwa, Toshihiko Maeda, Hajime Ikeda, Hiroki Thoren, Fredrik Arya, Niki Asano, Michiko Iqbal, Nayyar Diabetes Obes Metab Original Articles AIM: To examine the long‐term efficacy and safety of dapagliflozin, a sodium‐glucose co‐transporter‐2 (SGLT2) inhibitor used to treat type 1 diabetes, in the Japanese subpopulation of the DEPICT‐2 study. MATERIALS AND METHODS: Patients with type 1 diabetes were randomized to dapagliflozin 5 mg (n = 55), dapagliflozin 10 mg (n = 41) or placebo (n = 58) plus insulin for a 24‐week, double‐blind period followed by a 28‐week, single‐blind extension phase. RESULTS: From baseline to 24 weeks, dapagliflozin reduced HbA1c compared with placebo (mean change of −0.58% and −0.80% for 5 and 10 mg, respectively), and an HbA1c reduction was observed up to 52 weeks. Compared with placebo, dapagliflozin 5 and 10 mg increased the proportion of patients achieving HbA1c reductions of 0.5% or more without severe hypoglycaemia events and reduced glycaemic variability assessed via continuous glucose monitoring. Both dapagliflozin doses decreased body weight and total daily insulin dose at 24 weeks compared with placebo; these reductions were maintained up to 52 weeks. Diabetic ketoacidosis occurred in both dapagliflozin groups (one and two cases, respectively) but not with placebo. CONCLUSIONS: Efficacy and safety results from the Japanese subpopulation of the DEPICT‐2 study were generally consistent with those from the overall population, indicating that long‐term dapagliflozin adjunct to insulin therapy improves glycaemic control without an increased risk of hypoglycaemia but with a risk of diabetic ketoacidosis in Japanese patients with type 1 diabetes. Blackwell Publishing Ltd 2021-03-15 2021-07 /pmc/articles/PMC8251623/ /pubmed/33620762 http://dx.doi.org/10.1111/dom.14362 Text en © 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://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 Mathieu, Chantal Shiraiwa, Toshihiko Maeda, Hajime Ikeda, Hiroki Thoren, Fredrik Arya, Niki Asano, Michiko Iqbal, Nayyar Long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT‐2 study |
title | Long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT‐2 study |
title_full | Long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT‐2 study |
title_fullStr | Long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT‐2 study |
title_full_unstemmed | Long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT‐2 study |
title_short | Long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT‐2 study |
title_sort | long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in japanese patients with type 1 diabetes: subgroup analysis of the depict‐2 study |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251623/ https://www.ncbi.nlm.nih.gov/pubmed/33620762 http://dx.doi.org/10.1111/dom.14362 |
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