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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-UMIN000024703 |
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Date of registration:
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04/11/2016 |
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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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Examination of additive effects of dulaglutide and empagliflozin to type 2 diabetic patients with poor glycemic control despite insulin administration.
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Scientific title:
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Examination of additive effects of dulaglutide and empagliflozin to type 2 diabetic patients with poor glycemic control despite insulin administration. - Examination of additive effects of dulaglutide and empagliflozin to type 2 diabetic patients with poor glycemic control despite insulin administration. |
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Date of first enrolment:
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2016/11/04 |
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Target sample size:
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50 |
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Recruitment status: |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028421 |
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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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Hiroyuki Sato |
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Address:
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2-2-45 tsukuda nishiyodogawa-Ku, Osaka, 551-0001, Japan
Japan |
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Telephone:
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06-6471-9541 |
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Email:
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sato@med.kobe-u.ac.jp |
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Affiliation:
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Social medical corporations Aijinkai Chibune hospital Department of Endocrinology and diabetes |
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Name:
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Yoshikazu Tamori |
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Address:
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2-2-45 tsukuda nishiyodogawa-Ku, Osaka, 551-0001, Japan
Japan |
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Telephone:
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06-6471-9541 |
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Email:
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tamori@med.kobe-u.ac.jp |
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Affiliation:
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Social medical corporations Aijinkai Chibune hospital Department of Endocrinology and diabetes |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients with 75 years old and over,category 2,3. Patients who have not taken medicine for 3 months and over. Patients with impaired liver or kidney functions,who need adjustment of medicine.Patients with collagen disease or cancer.Patients who have economic reasons,and judged not to be appropriate by doctors.
Age minimum:
Not applicable
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 mellitus
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Intervention(s)
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Administration of dulaglutide 0.75mg once a week for 24 weeks.
Administration of empagliflozin 10mg per day for 24 weeks.
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Primary Outcome(s)
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HbA1c(%) For patients of 65 years old and over,we follow HbA1c with causion to lower limit.
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Secondary Outcome(s)
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We assess body weight,accomplishment rates of HbA1c under 7%,blood pressure,renal function,and body fat.
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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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