神戸大学附属図書館デジタルアーカイブ
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https://hdl.handle.net/20.500.14094/90005420
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2024-04-25
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90005420 (fulltext)
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メタデータID
90005420
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open access
出版タイプ
Version of Record
タイトル
Effects of Insulin Degludec and Insulin Glargine U300 on Day-to-Day Fasting Plasma Glucose Variability in Individuals with Type 1 Diabetes: A Multicenter, Randomized, Crossover Study (Kobe Best Basal Insulin Study 2)
著者
Miura, Hiroshi ; Sakaguchi, Kazuhiko ; Okada, Yuko ; Otowa-Suematsu, Natsu ; Yamada, Tomoko ; So, Anna ; Komada, Hisako ; Hirota, Yushi ; Kishi, Minoru ; Takeda, Akihiko ; Tominaga, Yoichi ; Nakamura, Tomoaki ; Kuroki, Yasuo ; Matsuda, Tomokazu ; Iida, Keiji ; Kajikawa, Michiko ; Ohara, Takeshi ; Yokota, Kazuki ; Hara, Kenta ; Tateya, Sanshiro ; Tamori, Yoshikazu ; Ogawa, Wataru
著者名
Miura, Hiroshi
著者ID
A1387
研究者ID
1000020444573
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=cc9462ee69a7a403520e17560c007669
著者名
Sakaguchi, Kazuhiko
坂口, 一彦
サカグチ, カズヒコ
所属機関名
医学研究科
著者ID
A1553
研究者ID
1000090782433
著者名
Okada, Yuko
岡田, 裕子
オカダ, ユウコ
所属機関名
医学部附属病院
著者名
Otowa-Suematsu, Natsu
著者名
Yamada, Tomoko
著者名
So, Anna
著者名
Komada, Hisako
著者ID
A1420
研究者ID
1000080566018
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=8d8b694f29475700520e17560c007669
著者名
Hirota, Yushi
廣田, 勇士
ヒロタ, ユウシ
所属機関名
医学部附属病院
著者名
Kishi, Minoru
著者名
Takeda, Akihiko
著者名
Tominaga, Yoichi
著者名
Nakamura, Tomoaki
著者名
Kuroki, Yasuo
著者名
Matsuda, Tomokazu
著者名
Iida, Keiji
著者名
Kajikawa, Michiko
著者名
Ohara, Takeshi
著者名
Yokota, Kazuki
著者名
Hara, Kenta
著者名
Tateya, Sanshiro
著者ID
A1938
研究者ID
1000090379397
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=fc3ce686271f4d14520e17560c007669
著者名
Tamori, Yoshikazu
田守, 義和
タモリ, ヨシカズ
所属機関名
医学研究科
著者ID
A1358
研究者ID
1000040294219
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=38228987a3a438c8520e17560c007669
著者名
Ogawa, Wataru
小川, 渉
オガワ, ワタル
所属機関名
医学研究科
収録物名
Diabetes Therapy
巻(号)
9(6)
ページ
2399-2406
出版者
Springer Heidelberg
刊行日
2018-12
公開日
2018-12-07
抄録
Introduction Administered basal insulin markedly influences the fasting plasma glucose (FPG) level of individuals with type 1 diabetes. Insulin degludec (IDeg) and insulin glargine U300 (IGlar U300) are now available as ultra-long-acting insulin formulations, but whether or how their glucose-stabilizing effects differ remains unclear. We will compare the effects of these basal insulins on parameters related to blood glucose control, with a focus on day-to-day glycemic variability, in individuals with type 1 diabetes treated with multiple daily injections. Methods A multicenter, randomized, open-label, crossover, comparative study (Kobe Best Basal Insulin Study 2) will be performed at 13 participating institutions in Japan. A total of 46 C-peptide-negative adult outpatients with type 1 diabetes will be randomly assigned 1:1 by a centralized allocation process to IGlar U300 (first period)/IDeg (second period) or IDeg (first period)/IGlar U300 (second period) groups, in which subjects will be treated with the corresponding basal insulin for consecutive 4-week periods. The basal insulin will be titrated to achieve an FPG of less than 130mg/dL initially and then less than 110mg/dL if feasible. In the last week of each period, plasma glucose will be determined seven times a day by self-monitoring of blood glucose (SMBG) and intraday and day-to-day glucose excursions will be determined by flash glucose monitoring (FGM). The primary end point is comparison of day-to-day glycemic variability as evaluated by the standard deviation (SD) of FPG during the last week of each treatment period. Secondary end points include the coefficient of variance of FPG, the frequency of severe hypoglycemia as evaluated by SMBG, the duration of hypoglycemia as evaluated by FGM, intraday glycemic variability calculated from both SMBG and FGM data, and the administered insulin dose. Planned Outcomes The results of the study will be submitted for publication in a peer-reviewed journal to report differences in the effects of two ultra-long-acting basal insulins, IDeg and IGlar U300. Conclusion This head-to-head comparison will be the first study to compare the effects of IDeg and IGlar U300 on day-to-day FPG variability in C-peptide-negative individuals with type 1 diabetes. Trial Registration Registered in University Hospital Medical Information Network (UMIN) Clinical Trials Registry as 000029630 on 20 June 2017.
キーワード
Basal-bolus insulin therapy
Day-to-day fasting plasma glucose variability
Insulin degludec
Insulin glargine U300
Type 1 diabetes
カテゴリ
医学研究科
医学部附属病院
学術雑誌論文
権利
© The Author(s) 2018.
This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
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資源タイプ
journal article
言語
English (英語)
ISSN
1869-6953
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eISSN
1869-6961
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関連情報
DOI
https://doi.org/10.1007/s13300-018-0523-0
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