Unique ID issued by UMIN | UMIN000032005 |
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Receipt number | R000036078 |
Scientific Title | Investigation on Renal Protective Effect by Luseogliflozin |
Date of disclosure of the study information | 2018/03/30 |
Last modified on | 2019/04/09 10:21:44 |
Investigation on Renal Protective Effect by Luseogliflozin
Investigation on Renal Protective Effect by Luseogliflozin
Investigation on Renal Protective Effect by Luseogliflozin
Investigation on Renal Protective Effect by Luseogliflozin
Japan |
Patients with type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To examine the effect of Luseogliflozin on eGFR change and renal function in the long term administration of Luseogliflozin to patients with type 2 diabetes mellitus as the subject.
Safety,Efficacy
eGFR variation before and after therapy at Week 48
Variations of the following items before and after therapy at Week 48
1)Physical findings
Body weight, BMI, blood pressure, pulse pressure, mean arterial pressure, pulse
2)Hematologic examination
HbA1c, fasting blood glucose level, ketone body fraction (acetoacetic acid, 3-hydroxybutyric acid, total ketone body)
3)Urinalysis
Urinary albumin/creatinine ratio, urine sugar (qualitative)
4)Double product
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Luseogliflozin 2.5 mg will be administered once a day for 48 weeks. In principle, 2.5 mg as Luseogliflozin will be administered once a day, but if the principal investigator or co-investigator judges that efficacy is insufficient, increase to 5 mg once a day is permissible.
65 | years-old | <= |
Not applicable |
Male and Female
1)A patient whose eGFR is less than 60 mL/min/1.73 m2
2)A patient aged 65 years or older
3)A patient whose HbA1c is 6.5% or more but less than 9.0%
4)A patient from whom written informed consent on his/her participation in this study can be obtained directly
1)A patient with type 1 diabetes
2)A patient who received an SGLT2 inhibitor within 8 weeks before the start of the treatment phase
3)A patient with severe ketosis, diabetic coma, or precoma
4)A patient with severe infections, before and after surgery, serious trauma
5)A patient with a medical history of hypersensitivity to components of SGLT2 inhibitors
6)A patient with pituitary gland dysfunction or adrenal gland dysfunction
7)A patient showing poor nutritional status, starvation status, irregular meal intake, insufficient dietary intake, or hyposthenia
8)A patient with a medical history of urinary tract infections due to urinary outflow disorder, etc., a patient with a medical history of severe genital infection, or patients currently infected
9)A patient who is prone to dehydration
10)A patient with severe renal dysfunction or a patient with end-stage renal failure during dialysis
11)A patient who is judged unsuitable for participation in this study by his/her attending physician
50
1st name | |
Middle name | |
Last name | Masafumi Kitaoka |
IMS Miyoshi General Hospital
Endocrine & Metabolism Center
974-3, Fujikubo, Miyoshi-machi, Iruma-gun, Saitama
049-258-2323
masa_kitaoka@mrc.biglobe.ne.jp
1st name | |
Middle name | |
Last name | Masafumi Kitaoka |
IMS Miyoshi General Hospital
Endocrine & Metabolism Center
974-3, Fujikubo, Miyoshi-machi, Iruma-gun, Saitama
049-258-2323
masa_kitaoka@mrc.biglobe.ne.jp
Nishitokyo Diabetes Research Group of Specified Nonprofit Organization
Taisho Toyama Pharmaceutical Co., Ltd.
Profit organization
NO
社会医療法人財団大和会東大和病院(東京都)
医療法人社団桜一会かんの内科(東京都)
医療法人社団明芳会イムス三芳総合病院(埼玉県)
医療法人社団南山寿会中島内科クリニック(東京都)
医療法人社団ユスタヴィア多摩センタークリニックみらい(東京都)
2018 | Year | 03 | Month | 30 | Day |
Unpublished
30
The study is not registered to UMIN because the specific clinical research studies are registered and released to jRCT due to the Clinical Research Law enforcement.
2019 | Year | 04 | Month | 09 | Day |
Terminated
2018 | Year | 01 | Month | 23 | Day |
2018 | Year | 02 | Month | 22 | Day |
2018 | Year | 03 | Month | 31 | Day |
2020 | Year | 06 | Month | 28 | Day |
2018 | Year | 03 | Month | 30 | Day |
2019 | Year | 04 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036078
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