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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-UMIN000026644 |
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Date of registration:
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01/04/2017 |
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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 the DPP-4 inhibitor, saxagliptin on glucose variability in type 2 diabetes patients with Chronic kidney disease
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Scientific title:
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Effect of the DPP-4 inhibitor, saxagliptin on glucose variability in type 2 diabetes patients with Chronic kidney disease - Effect of saxagliptin on glucose variability in type 2 diabetes patients with CKD |
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Date of first enrolment:
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2017/04/01 |
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Target sample size:
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26 |
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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=R000030371 |
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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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Hiroshi Fujino |
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Address:
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1-9-2, Otemachi, Chiyoda-ku, Tokyo
Japan |
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Telephone:
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0352057200 |
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Email:
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hiroshi.fujino@kyowa-kirin.co.jp |
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Affiliation:
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Kyowa Hakko Kirin,co.,Ltd Medical Affairs Department |
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Name:
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Tahashi Maruyama |
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Address:
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30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo
Japan |
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Telephone:
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03-3972-8111 |
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Email:
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maruyama.takashi@nihon-u.ac.jp |
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Affiliation:
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Nihon University Itabashi Hospital Division of Nephrology, Hypertension and Endocrinology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patients who have history of hypersensitivity to saxagliptin or the other dpp-4 inhibitors 2. Patients who have history of administration of incretin-related drugs within 4 weeks 3. Patients who changed anti-diabetic drugs, diet thrapy or exercise thrapy within 4 weeks 4. Patients who have end stage renal disease undergoing maintenance dialysis, or after renal transplantation 5. Patients who have history of severe ketosis, diabetic coma, or precoma within 6 months 6. Patients who have history of cancer within 5 years 7. Patients who have liver disfunction with AST or ALT>=3 x upper limit of normal 8. Patients who experienced severe traumatotherapy requiring surgery or surgery with general anesthesia within 6 months 9. Women who is pregnant or planned to become pregnant 10. Patients who 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 patients with CKD
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Intervention(s)
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Administration of saxagliptin 2.5mg or 5 mg once a day before breakfast.
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Primary Outcome(s)
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Change in Mean Amplitude of Glycemic Excursions from baseline to week 4 after the start of administration
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Secondary Outcome(s)
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Change in glucose variability and biomakers from baseline to week 4 after the start of administration
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Source(s) of Monetary Support
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Kyowa Hakko Kirin,co.,Ltd
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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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Date Posted:
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Date Completed:
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URL:
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