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/20.500.14094/90005298
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2024-04-27
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90005298 (fulltext)
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90005298
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open access
出版タイプ
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タイトル
Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: A Randomized, Open-Label, Parallel-Group, Multicenter Study
著者
Otowa-Suematsu, Natsu ; Sakaguchi, Kazuhiko ; Nakamura, Tomoaki ; Hara, Kenta ; Kishi, Minoru ; Hashimoto, Naoko ; Yokota, Kazuki ; Yoshino, Hiroshi ; Kuroki, Yasuo ; Nishiumi, Tomoko ; Sou, Anna ; Komada, Hisako ; Okada, Yuko ; Hirota, Yushi ; Tamori, Yoshikazu ; Ogawa, Wataru
著者名
Otowa-Suematsu, Natsu
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
著者名
Nakamura, Tomoaki
著者名
Hara, Kenta
著者名
Kishi, Minoru
著者名
Hashimoto, Naoko
著者名
Yokota, Kazuki
著者名
Yoshino, Hiroshi
著者名
Kuroki, Yasuo
著者名
Nishiumi, Tomoko
著者名
Sou, Anna
著者名
Komada, Hisako
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(5)
ページ
2067-2079
出版者
Springer
刊行日
2018-10
公開日
2018-10-24
抄録
We comprehensively evaluated the effects of combination therapy with insulin glargine and the incretin-based drugs lixisenatide or vildagliptin in Japanese patients with type 2 diabetes. Methods In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with insulin glargine and sitagliptin. The dose of insulin glargine was titrated after the switch to maintain fasting blood glucose at approximately 110 mg/dL. The primary end points of the study were the change in glycosylated hemoglobin (HbA(1c)) level between before and 12 weeks after the treatment switch, the proportion of patients achieving an HbA(1c) level below 7.0%, and the postprandial increase in glucose concentration as assessed by self-monitoring of blood glucose. Results The change in HbA(1c) level from baseline to 12 weeks did not differ significantly between the lixisenatide and vildagliptin groups (- 0.6 ± 0.7% and - 0.6 ± 1.2%, respectively, P = 0.920). Neither the proportion of patients achieving an HbA(1c) level below 7.0% nor the postprandial increase in glucose concentration was different between two groups. Body weight and serum low density lipoprotein (LDL) cholesterol level decreased significantly in the lixisenatide and vildagliptin groups, respectively. Both drugs were associated with mild gastrointestinal symptoms but not with severe hypoglycemia. Vildagliptin was associated with elevation of serum aspartate transaminase. Treatment satisfaction as assessed with the Diabetes Treatment Satisfaction Questionnaire did not differ significantly between the two groups. Conclusion The combinations of basal insulin and either lixisenatide or vildagliptin have similar efficacies with regard to improvement of glycemic control. This trial has been registered with UMIN (No. 000010769).
キーワード
Insulin glargine
Lixisenatide
Vildagliptin
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/s13300-018-0505-2
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