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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-UMIN000015033 |
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Date of registration:
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03/09/2014 |
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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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Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial-
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Scientific title:
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Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial- - Comparison of DPP-4 Inhibitors vs. Dapagliflozin in combination with insulin using CGM |
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Date of first enrolment:
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2014/09/07 |
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Target sample size:
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36 |
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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=R000017489 |
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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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Phase IV
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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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Hideaki Miyoshi |
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Address:
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Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
Japan |
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Telephone:
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011-706-5915 |
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Email:
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hidemiyoshi2003@yahoo.co.jp |
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Affiliation:
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Hokkaido University Hospital Department of Internal Medicine II |
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Name:
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Hideaki Miyoshi |
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Address:
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Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
Japan |
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Telephone:
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011-706-5915 |
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Email:
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hidemiyoshi2003@yahoo.co.jp |
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Affiliation:
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Hokkaido University Hospital Department of Internal Medicine II |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) severe hepatic dysfunction, renal dysfunction, heart failure, 2) history of anaphylaxis of drugs we use, 3) pregnancy, 4) lower than 45ml/min of eGFR, 5)lower Body mass index than 22kg/m2 6) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Age minimum:
20years-old
Age maximum:
80years-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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Sitagliptin Vildagliptin Teneligliptin Linagliptin Alogliptin Saxagliptin
Dapagliflozin
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Primary Outcome(s)
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Mean Amplitude of glycemic excursions: MAGE
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Secondary Outcome(s)
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1) M-value 2) glucose area under the curve (over 180mg/dl and below 70mg/dl) 3) fasting plasma glucose, HbA1c, glycoalbumin, 1.5AG 4) beta cell function 5) several biomarkers 6) body weight, Body Mass Index 7) blood pressure 8)multiple regression analysis 9)insulin dose
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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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