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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000021516 |
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Date of registration:
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18/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of saxagliptin on endothelial function in patients with type 2 diabetes; Multi-center clinical trial
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Scientific title:
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Effect of saxagliptin on endothelial function in patients with type 2 diabetes; Multi-center clinical trial - Effect of saxagliptin on endothelial function in patients with type 2 diabetes; Multi-center clinical trial |
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Date of first enrolment:
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2016/04/01 |
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Target sample size:
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40 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023879 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yukihito Higashi |
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Address:
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1-2-3 Kasumi, Minamiku, Hiroshima
Japan |
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Telephone:
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082-257-5831 |
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Email:
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yhigashi@hiroshima-u.ac.jp |
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Affiliation:
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Hiroshima University Hospital Medical Center for Translational and Clinical Research |
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Name:
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Yukihito Higashi |
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Address:
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1-2-3 Kasumi, Minamiku, Hiroshima
Japan |
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Telephone:
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082-257-5831 |
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Email:
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yhigashi@hiroshima-u.ac.jp |
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Affiliation:
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Hiroshima University Hospital Medical Center for Translational and Clinical Research |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Has history of hypersensitivity to ipragliflozin or any other excipient of saxagliptin 2. Has history of administration of DPP-4 inhibitor within 4 weeks before initiation of the study 3.patient with insulin dependent diabetes mellitus 4. Has history of myocardial infarction, angina, cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attacks within 3 months before initiation of the study 5. patient with ASO 6. With severe renal dysfunction (eGRF <50 mL/min or patient undergoing artificial dialysis) 7. Has history of severe ketosis, diabetic coma, or precoma within 6 months 8. Has history of cancer, severe infection 9. Pregnant, possibly pregnant, planned to become pregnant or nursing women 10. Are considered not eligible for the study by the attending doctor due to other reasons
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Type 2 diabetes
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Intervention(s)
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Administration of saxagliptin 5 mg once a day post breakfast.
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Primary Outcome(s)
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Change in FMD from baseline to week 12
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Source(s) of Monetary Support
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KYOWA KIRIN.
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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02/10/2017 |
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URL:
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