| ○種別 (必須): | □ | 学術論文 (審査論文)
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| ○言語 (必須): | □ | 英語
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| ○カテゴリ (推奨): |
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| ○学究種別 (推奨): |
| ○組織 (推奨): |
| ○著者 (必須): | 1. | 松久 宗英
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| 2. | (英) Koyama M. (日) (読)
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| 3. | (英) Cheng X (日) (読)
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| 4. | (英) Takahashi Y (日) (読)
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| 5. | (英) Riiddle C M (日) (読)
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| 6. | (英) Boli B G (日) (読)
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| 7. | (英) Hirose T (日) (読)
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| 8. | (英) .on behalf of the Edition JP 1 study group (日) (読)
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| ○題名 (必須): | □ | (英) New insulin glargine 300 U/mL versus glargine 100 U/mL in Japanese adults with type 1 diabetes using basal and mealtime insulinglucose control and hypoglycaemia in a randomized controlled trial (日)
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| ○要約 (任意): | □ | (英) 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. 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. 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. 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. (日)
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| ○キーワード (推奨): | 1. | (英) Adult (日) (読)
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| 2. | (英) Delayed-Action Preparations (日) (読)
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| 3. | (英) Diabetes Mellitus, Type 1 (日) (読)
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| 4. | (英) Dose-Response Relationship, Drug (日) (読)
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| 5. | (英) Drug Administration Schedule (日) (読)
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| 6. | (英) Drug Resistance, Multiple (日) (読)
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| 7. | (英) Drug Therapy, Combination (日) (読)
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| 8. | (英) Female (日) (読)
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| 9. | (英) Follow-Up Studies (日) (読)
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| 10. | (英) Hemoglobin A, Glycosylated (日) (読)
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| 11. | (英) Humans (日) (読)
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| 12. | (英) Hyperglycemia (日) (読)
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| 13. | (英) Hypoglycemia (日) (読)
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| 14. | (英) Hypoglycemic Agents (日) (読)
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| 15. | (英) Insulin Detemir (日) (読)
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| 16. | (英) Insulin Glargine (日) (読)
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| 17. | 日本 (Japan)
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| 18. | (英) Male (日) (読)
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| 19. | (英) Middle Aged (日) (読)
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| 20. | リスク (risk)
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| ○発行所 (推奨): |
| ○誌名 (必須): | □ | Diabetes, Obesity & Metabolism (Blackwell Publishing Ltd)
(pISSN: 1462-8902, eISSN: 1463-1326)
| ○ISSN (任意): | □ | 1463-1326
ISSN: 1462-8902
(pISSN: 1462-8902, eISSN: 1463-1326) Title: Diabetes, obesity & metabolismTitle(ISO): Diabetes Obes MetabPublisher: Wiley Publishing (NLM Catalog)
(Wiley)
(Scopus)
(CrossRef)
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| ○巻 (必須): | □ | 18
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| ○号 (必須): | □ | 4
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| ○頁 (必須): | □ | 375 383
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| ○都市 (任意): |
| ○年月日 (必須): | □ | 西暦 2016年 4月 初日 (平成 28年 4月 初日)
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| ○URL (任意): |
| ○DOI (任意): | □ | 10.1111/dom.12619 (→Scopusで検索)
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| ○PMID (任意): | □ | 26662964 (→Scopusで検索)
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| ○CRID (任意): |
| ○Scopus (任意): | 1. | 2-s2.0-84959866323
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| ○備考 (任意): | 1. | (英) Article.ELocationID: 10.1111/dom.12619 (日)
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| 2. | (英) Article.DataBankList.DataBank.DataBankName: ClinicalTrials.gov (日)
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| 3. | (英) Article.DataBankList.DataBank.AccessionNumberList.AccessionNumber: NCT01689129 (日)
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| 4. | (英) Article.PublicationTypeList.PublicationType: Clinical Trial, Phase III (日)
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| 5. | (英) Article.PublicationTypeList.PublicationType: Journal Article (日)
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| 6. | (英) Article.PublicationTypeList.PublicationType: Multicenter Study (日)
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| 7. | (英) Article.PublicationTypeList.PublicationType: Randomized Controlled Trial (日)
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| 8. | (英) Article.PublicationTypeList.PublicationType: Research Support, Non-U.S. Gov't (日)
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| 9. | (英) KeywordList.Keyword: basal insulin (日)
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| 10. | (英) KeywordList.Keyword: glycaemic control (日)
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| 11. | (英) KeywordList.Keyword: insulin analogues (日)
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| 12. | (英) KeywordList.Keyword: phase III study (日)
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| 13. | (英) KeywordList.Keyword: randomised trial (日)
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| 14. | (英) KeywordList.Keyword: type 1 diabetes (日)
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