| Item type |
文献 / Documents(1) |
| 公開日 |
2020-12-17 |
| アクセス権 |
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アクセス権 |
open access |
| 資源タイプ |
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|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
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資源タイプ |
journal article |
| 出版社版DOI |
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|
識別子タイプ |
DOI |
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関連識別子 |
https://doi.org/10.1111/dom.12619 |
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|
言語 |
ja |
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|
関連名称 |
10.1111/dom.12619 |
| 出版タイプ |
|
|
出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| タイトル |
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|
タイトル |
New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin : glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1) |
|
言語 |
en |
| 著者 |
松久, 宗英
コヤマ
Cheng, X.
タカハシ
Riddle, M. C.
Bolli, G. B.
ヒロセ
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| 抄録 |
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内容記述タイプ |
Abstract |
|
内容記述 |
Aim: To compare efficacy and safety of new insulin glargine 300 U/ml (Gla‐300) with that of insulin glargine 100 U/ml (Gla‐100) in Japanese adults with type 1 diabetes.
Methods: The EDITION JP 1 study (NCT01689129) was a 6‐month, multicentre, open‐label, phase III study. Participants (n = 243) were randomized to Gla‐300 or Gla‐100 while continuing mealtime insulin. Basal insulin was titrated with the aim of achieving a fasting self‐monitored plasma glucose target of 4.4–7.2 mmol/l. The primary endpoint was change in glycated haemoglobin (HbA1c) over 6 months. Safety measures included hypoglycaemia and change in body weight.
Results: Gla‐300 was non‐inferior to Gla‐100 for the primary endpoint of HbA1c change over the 6‐month period {least squares [LS] mean difference 0.13 % [95 % confidence interval (CI) −0.03 to 0.29]}. The annualized rate of confirmed (≤3.9 mmol/l) or severe hypoglycaemic events was 34 % lower with Gla‐300 than with Gla‐100 at night [rate ratio 0.66 (95 % CI 0.48–0.92)] and 20 % lower at any time of day [24 h; rate ratio 0.80 (95 % CI 0.65–0.98)]; this difference was most pronounced during the first 8 weeks of treatment. Severe hypoglycaemia was infrequent. The basal insulin dose increased in both groups (month 6 dose: Gla‐300 0.35 U/kg/day, Gla‐100 0.29 U/kg/day). A between‐treatment difference in body weight change over 6 months favouring Gla‐300 was observed [LS mean difference −0.6 kg (95 % CI −1.1 to −0.0); p = 0.035]. Adverse event rates were comparable between the groups.
Conclusions: In Japanese adults with type 1 diabetes using basal plus mealtime insulin, less hypoglycaemia was observed with Gla‐300 than with Gla‐100, particularly during the night, while glycaemic control did not differ. |
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言語 |
en |
| キーワード |
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|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
basal insulin |
| キーワード |
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|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
glycaemic control |
| キーワード |
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|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
insulin analogues |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
phase III study |
| キーワード |
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|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
randomised trial |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
type 1 diabetes |
| 書誌情報 |
en : Diabetes, Obesity and Metabolism: A Journal of Pharmacology and Therapeutics
巻 18,
号 4,
p. 375-383,
発行日 2015-12-11
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| 収録物ID |
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収録物識別子タイプ |
ISSN |
|
収録物識別子 |
14631326 |
| 収録物ID |
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収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA11435496 |
| 出版者 |
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出版者 |
John Wiley & Sons |
|
言語 |
en |
| 権利情報 |
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|
言語 |
en |
|
権利情報 |
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
| EID |
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|
識別子 |
328714 |
|
識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
dom_18_4_375.pdf (320 KB)
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