Unique ID issued by UMIN | UMIN000008133 |
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Receipt number | R000009573 |
Scientific Title | Evaluation of efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease |
Date of disclosure of the study information | 2012/06/12 |
Last modified on | 2013/12/13 10:01:55 |
Evaluation of efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease
Evaluation of efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease
Evaluation of efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease
Evaluation of efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease
Japan |
Type 2 Diabetic Patients with chronic kidney Disease
Endocrinology and Metabolism | Nephrology | Adult |
Others
NO
We will evaluate the efficacy and safety of Alogliptin in type 2 diabetic patients with chronic kidney disease. In this study, the target HbA1c (NGSP) would be 6.9%.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
HbA1c, at-any-time blood sugar level, blood pressure, albuminurina, proteinuria, eGFR at 0, 3, 6 and 12 months after starting of treatment
Body weight and side effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Add-on Alogliptin
Not applicable |
Not applicable |
Male and Female
1)Patients with chronic kidney disease 2)Type 2 Diabetic Patients 3)Patient who has not taken DPP-4 inhibitor
4)Patient who is competent to understand the aim of this study and agree on it
1)Type I and secondary diabetes
2)Severe infectious disease, before or after surgery, and severa trauma
3)Severe liver dysfunction (AST: 100 IU/l or higher)
4)Under treatment with an incretin preparation, such as other DPP-4 inhibitors, at the time of study initiation
5)Pregnant, lactating, and possibly pregnant women and those planning to become pregnant
6)Under treatment with therapeutic drugs not concomitantly administrable with incretin preparations, such as DPP-4 inhibitors, with regard to national health insurance
7)Past medical history of hypersensitivity to alogliptin
8)Judged as ineligible by clinical investigators
50
1st name | |
Middle name | |
Last name | Yasuhiko Tomino |
Juntendo University Faculty of Medicine
Department of Internal Medicine, Division of Nephrology
2-1-1 Hongo, Bunkyo-ku, Tokyo
03-5802-1065
yasu@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Hitoshi Suzuki |
Juntendo University Faculty of Medicine
Department of Internal Medicine, Division of Nephrology
2-1-1 Hongo, Bunkyo-ku, Tokyo
03-3813-3111
shitoshi@juntendo.ac.jp
Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine
none
Self funding
A Clinic named 'Meguro Orthopaedics Surgery Internal Medicine'
NO
順天堂大学病院(東京都)、目黒整形外科内科(東京都)
2012 | Year | 06 | Month | 12 | Day |
Published
Completed
2012 | Year | 04 | Month | 14 | Day |
2012 | Year | 07 | Month | 01 | Day |
2013 | Year | 12 | Month | 01 | Day |
2012 | Year | 06 | Month | 10 | Day |
2013 | Year | 12 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009573
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