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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-UMIN000018445 |
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Date of registration:
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28/07/2015 |
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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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Efficacy and safety of DPP-4 inhibitors in diabetic patients undergoing hemodialysis
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Scientific title:
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Efficacy and safety of DPP-4 inhibitors in diabetic patients undergoing hemodialysis - DPP-4 inhibitors in diabetic patients on HD |
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Date of first enrolment:
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2015/08/01 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021357 |
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Study type:
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Interventional |
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Study design:
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Parallel 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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Masanori Abe |
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Address:
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30-1, Oyaguchi Kami-chou, Itabshi-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3972-8111 |
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Email:
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mabe@med.nihon-u.ac.jp |
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Affiliation:
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Nihon University Itabashi Hospital Nephrology, Hypertension and Endocrinology |
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Name:
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Masanori Abe |
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Address:
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30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan
Japan |
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Telephone:
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03-3972-8111 |
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Email:
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mabe@med.nihon-u.ac.jp |
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Affiliation:
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Nihon University Itabashi Hospital Nephrology, Hypertension and Endocrinology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Infectious disease, 2) Thyroid disease, 3) Malignant tumors, 4) Liver dysfunction, 5) Type 1 diabetes, 6)Treatment with steroids or immunosuppressant, 7) History of severe heart failure, angina, myocardial infarction, or stroke within the past 6 months, 8) Currently hospitalization.
Age minimum:
20years-old
Age maximum:
85years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Diabetes patients with hemodialysis
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Intervention(s)
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DPP-4 inhibitor, saxagliptin 2.5 mg daily are added on the standard therapy for 24 weeks.Standard therapies are defined as insulin therapy, alpha-glucosidase inhibitors, meglitinides, or diet therapy.
Standard therapy excluding DPP-4 inhibitors: 1) Insulin therapy alone, 2) Insulin therapy with alpha-glucosidase inhibitor, 3) alpha-glucosidase inhibitors alone, 4) Meglitinide alone, 5) alpha-GI with meglitinide, 6) Diet therapy alone. Observational period: for 24 weeks
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Primary Outcome(s)
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Change in glyated albumin level by DPP-4 inhibitors for 24 weeks
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Secondary Outcome(s)
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Changes in glyated hemoglobin level and postprandial plasma glucose level by DPP-4 inhibitors, and safety profiles for 24 weeks.
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Source(s) of Monetary Support
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None
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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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