| ○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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| ○審査 (推奨): |
| ○カテゴリ (推奨): |
| ○共著種別 (推奨): | □ | 国内共著 (徳島大学内研究者と国内(学外)研究者との共同研究 (国外研究者を含まない))
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| ○学究種別 (推奨): |
| ○組織 (推奨): |
| ○著者 (必須): | 1. | (英) Tanaka A (日) (読)
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| 2. | (英) Inoue T (日) (読)
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| 3. | (英) Kitakaze M (日) (読)
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| 4. | (英) Oyama J (日) (読)
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| 5. | 佐田 政隆 ([徳島大学.大学院医歯薬学研究部.医学域.医科学部門.内科系.循環器内科学])
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| 6. | (英) Taguchi I (日) (読)
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| 7. | (英) Shimizu W (日) (読)
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| 8. | (英) Watada H (日) (読)
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| 9. | (英) Ako J (日) (読)
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| 10. | (英) Sakata Y (日) (読)
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| 11. | (英) Anzai T (日) (読)
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| 12. | (英) Uematsu M (日) (読)
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| 13. | (英) Suzuki M (日) (読)
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| 14. | (英) Eguchi K (日) (読)
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| 15. | (英) Yamashina A (日) (読)
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| 16. | (英) Saito Y (日) (読)
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| 17. | (英) Sato Y (日) (読)
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| 18. | (英) Ueda S (日) (読)
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| 19. | (英) Murohara T (日) (読)
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| 20. | (英) Node K (日) (読)
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| ○題名 (必須): | □ | (英) Rationale and design of a randomized trial to test the safety and non-inferiority of canagliflozin in patients with diabetes with chronic heart failure: the CANDLE trial. (日)
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| ○副題 (任意): |
| ○要約 (任意): | □ | (英) Because type 2 diabetes mellitus is associated strongly with an increased risk of cardiovascular diseases, the number of patients with diabetes with chronic heart failure is increasing steadily. However, clinical evidence of therapeutic strategies in such patients is still lacking. A recent randomized, placebo-controlled trial in patients with type 2 diabetes with high cardiovascular risk demonstrated that the SGLT2 inhibitor, empagliflozin, reduced the incidence of hospitalization for heart failure. Because SGLT2 inhibitors cause a reduction in body weight and blood pressure in addition to improving glycemic control, they have the potential to exert beneficial effects on the clinical pathophysiology of heart failure. The aim of the ongoing CANDLE trial is to test the safety and non-inferiority of canagliflozin, another SGLT2 inhibitor, compared with glimepiride, a sulfonylurea agent, in patients with type 2 diabetes mellitus and chronic heart failure. A total of 250 patients with type 2 diabetes who are drug-naïve or taking any anti-diabetic agents and suffering from chronic heart failure with a New York Heart Association classification I to III will be randomized centrally into either canagliflozin or glimepiride groups (1: 1) using the dynamic allocation method stratified by age (<65, ≥65 year), HbA1c level (<6.5, ≥6.5 %), and left ventricular ejection fraction (<40, ≥40 %). After randomization, all the participants will be given the add-on study drug for 24 weeks in addition to their background therapy. The primary endpoint is the percentage change from baseline in NT-proBNP after 24 weeks of treatment. The key secondary endpoints after 24 weeks of treatment are the change from baseline in glycemic control, blood pressure, body weight, lipid profile, quality of life score related to heart failure, and cardiac and renal function. The CANDLE trial is the first to assess the safety and non-inferiority of canagliflozin in comparison with glimepiride in patients with type 2 diabetes with chronic heart failure. This trial has the potential to evaluate the clinical safety and efficacy of canagliflozin on heart failure. Trial registration Unique trial Number, UMIN000017669. (日)
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| ○キーワード (推奨): | 1. | (英) Adult (日) (読)
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| 2. | (英) Aged (日) (読)
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| 3. | (英) Aged, 80 and over (日) (読)
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| 4. | (英) Benzhydryl Compounds (日) (読)
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| 5. | (英) Blood Glucose (日) (読)
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| 6. | (英) Blood Pressure (日) (読)
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| 7. | (英) Canagliflozin (日) (読)
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| 8. | (英) Chronic Disease (日) (読)
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| 9. | (英) Diabetes Mellitus, Type 2 (日) (読)
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| 10. | (英) Female (日) (読)
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| 11. | (英) Glucosides (日) (読)
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| 12. | (英) Heart Failure (日) (読)
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| 13. | (英) Humans (日) (読)
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| 14. | (英) Hypoglycemic Agents (日) (読)
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| 15. | (英) Male (日) (読)
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| 16. | (英) Metformin (日) (読)
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| 17. | (英) Middle Aged (日) (読)
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| 18. | (英) Quality of Life (日) (読)
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| 19. | (英) Sulfonylurea Compounds (日) (読)
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| ○発行所 (推奨): | □ | BioMed Central Ltd.
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| ○誌名 (必須): | □ | Cardiovascular Diabetology ([BioMed Central Ltd.])
(eISSN: 1475-2840)
| ○ISSN (任意): | □ | 1475-2840
ISSN: 1475-2840
(eISSN: 1475-2840) Title: Cardiovascular diabetologyTitle(ISO): Cardiovasc DiabetolPublisher: BioMed Central (NLM Catalog)
(Scopus)
(CrossRef)
(Scopus information is found. [need login])
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| ○巻 (必須): | □ | 15
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| ○号 (必須): | □ | 1
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| ○頁 (必須): | □ | 57 57
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| ○都市 (任意): |
| ○年月日 (必須): | □ | 西暦 2016年 4月 4日 (平成 28年 4月 4日)
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| ○URL (任意): |
| ○DOI (任意): | □ | 10.1186/s12933-016-0381-x (→Scopusで検索)
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| ○PMID (任意): | □ | 27044332 (→Scopusで検索)
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| ○CRID (任意): |
| ○WOS : | □ | 000373443400001
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| ○備考 (任意): | 1. | (英) Article.ELocationID: 10.1186/s12933-016-0381-x (日)
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| 2. | (英) Article.DataBankList.DataBank.DataBankName: JPRN (日)
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| 3. | (英) Article.DataBankList.DataBank.AccessionNumberList.AccessionNumber: UMIN000017669 (日)
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| 4. | (英) Article.PublicationTypeList.PublicationType: Journal Article (日)
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| 5. | (英) Article.PublicationTypeList.PublicationType: Randomized Controlled Trial (日)
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| 6. | (英) Article.PublicationTypeList.PublicationType: Research Support, Non-U.S. Gov't (日)
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| 7. | (英) OtherID: PMC4820875 (日)
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| 8. | (英) KeywordList.Keyword: Canagliflozin (日)
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| 9. | (英) KeywordList.Keyword: Chronic heart failure (日)
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| 10. | (英) KeywordList.Keyword: Glimepiride (日)
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| 11. | (英) KeywordList.Keyword: NT-proBNP (日)
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| 12. | (英) KeywordList.Keyword: Non-inferiority (日)
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| 13. | (英) KeywordList.Keyword: SGLT2 inhibitor (日)
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| 14. | (英) KeywordList.Keyword: Safety (日)
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| 15. | (英) KeywordList.Keyword: Type 2 diabetes mellitus (日)
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