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著作: [松久 宗英]/Koyama M./Cheng X/Takahashi Y/Riiddle C M/Boli B G/Hirose T/.on behalf of the Edition JP 1 study group/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/[Diabetes, Obesity & Metabolism]

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EID
328714
EOID
879290
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LastModified
2017年12月12日(火) 10:21:39
Operator
三木 ちひろ
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Owner
松久 宗英
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種別 必須 学術論文(審査論文)
言語 必須 英語
招待 推奨
審査 推奨
カテゴリ 推奨
共著種別 推奨
学究種別 推奨
組織 推奨
著者 必須
  1. 松久 宗英([徳島大学.先端酵素学研究所.基幹研究部門]/徳島大学病院アンチエイジングセンター センター長(併任)/徳島大学先端酵素学研究所長(併任))
    役割 任意
    貢献度 任意
    学籍番号 推奨
  2. (英) Koyama M.
    役割 任意
    貢献度 任意
    学籍番号 推奨
  3. (英) Cheng X
    役割 任意
    貢献度 任意
    学籍番号 推奨
  4. (英) Takahashi Y
    役割 任意
    貢献度 任意
    学籍番号 推奨
  5. (英) Riiddle C M
    役割 任意
    貢献度 任意
    学籍番号 推奨
  6. (英) Boli B G
    役割 任意
    貢献度 任意
    学籍番号 推奨
  7. (英) Hirose T
    役割 任意
    貢献度 任意
    学籍番号 推奨
  8. (英) .on behalf of the Edition JP 1 study group
    役割 任意
    貢献度 任意
    学籍番号 推奨
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

副題 任意
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.

キーワード 推奨
  1. (英) Adult
  2. (英) Delayed-Action Preparations
  3. (英) Diabetes Mellitus, Type 1
  4. (英) Dose-Response Relationship, Drug
  5. (英) Drug Administration Schedule
  6. (英) Drug Resistance, Multiple
  7. (英) Drug Therapy, Combination
  8. (英) Female
  9. (英) Follow-Up Studies
  10. (英) Hemoglobin A, Glycosylated
  11. (英) Humans
  12. (英) Hyperglycemia
  13. (英) Hypoglycemia
  14. (英) Hypoglycemic Agents
  15. (英) Insulin Detemir
  16. (英) Insulin Glargine
  17. 日本(Japan)
  18. (英) Male
  19. (英) Middle Aged
  20. リスク(risk)
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 & metabolism
Title(ISO): Diabetes Obes Metab
Publisher: Wiley Publishing
 (NLM Catalog  (Wiley  (Scopus  (CrossRef (Scopus information is found. [need login])
必須 18
必須 4
必須 375 383
都市 任意
年月日 必須 2016年 4月 初日
URL 任意
DOI 任意 10.1111/dom.12619    (→Scopusで検索)
PMID 任意 26662964    (→Scopusで検索)
CRID 任意
WOS 任意
Scopus 任意 2-s2.0-84959866323
評価値 任意
被引用数 任意
指導教員 推奨
備考 任意
  1. (英) Article.ELocationID: 10.1111/dom.12619

  2. (英) Article.DataBankList.DataBank.DataBankName: ClinicalTrials.gov

  3. (英) Article.DataBankList.DataBank.AccessionNumberList.AccessionNumber: NCT01689129

  4. (英) Article.PublicationTypeList.PublicationType: Clinical Trial, Phase III

  5. (英) Article.PublicationTypeList.PublicationType: Journal Article

  6. (英) Article.PublicationTypeList.PublicationType: Multicenter Study

  7. (英) Article.PublicationTypeList.PublicationType: Randomized Controlled Trial

  8. (英) Article.PublicationTypeList.PublicationType: Research Support, Non-U.S. Gov't

  9. (英) KeywordList.Keyword: basal insulin

  10. (英) KeywordList.Keyword: glycaemic control

  11. (英) KeywordList.Keyword: insulin analogues

  12. (英) KeywordList.Keyword: phase III study

  13. (英) KeywordList.Keyword: randomised trial

  14. (英) KeywordList.Keyword: type 1 diabetes