徳島大学 教育・研究者情報データベース(EDB)

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))

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2. (英) Koyama M.

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3. (英) Cheng X

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4. (英) Takahashi Y

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5. (英) Riiddle C M

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6. (英) Boli B G

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7. (英) Hirose T

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8. (英) .on behalf of the Edition JP 1 study group

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(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

(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.

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)

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