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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-UMIN000018979 |
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Date of registration:
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11/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Non-inferiority of iPragliflozin and metformin on glucose metabolism, pleiotropic effects and safety in type2 diabetes
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Scientific title:
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Non-inferiority of iPragliflozin and metformin on glucose metabolism, pleiotropic effects and safety in type2 diabetes - Effects of iPragliflozin on glucose metabolism and pleiotropic effects |
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Date of first enrolment:
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2014/11/26 |
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Target sample size:
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40 |
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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=R000021955 |
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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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Yosuke Okada |
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Address:
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1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
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Telephone:
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+8100936031611 |
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Email:
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y-okada@med.uoeh-u.ac.jp |
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Affiliation:
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University of Occupational and Environmental Health First Department of Internal Medicine, School of Medicine |
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Name:
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Hiroko Mori |
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Address:
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1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
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Telephone:
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+8100936031611 |
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Email:
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morihiro@med.uoeh-u.ac.jp |
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Affiliation:
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University of Occupational and Environmental Health First Department of Internal Medicine, School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (1) With diabetic ketoacidosis, diabetic coma and type 1 diabetes (2) With infection (3)Has arteriosclerotic disease (myocardial infarction, stroke and so on) and history of them (4) Heavy use of alcohol (5) Considered as inadequate by the investigator
Age minimum:
20years-old
Age maximum:
75years-old
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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Ipragliflozin 50 mg/day (6months)
Metformin 750mg 3X/day(4days), 1500 mg 3X/day(5 days), 2250mg 3X/day(6months)
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Primary Outcome(s)
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Changes in glucose metabolism at 14days after treatment
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Secondary Outcome(s)
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(1) Changes in the variables listed below. 1-lipid profile 2-bome metabolism 3-renal function 4-urinanalysis (2) safety
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Source(s) of Monetary Support
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Merck and Co., Inc., Kenilworth, N.J., U.S.A.
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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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