Unique ID issued by UMIN | UMIN000023959 |
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Receipt number | R000027582 |
Scientific Title | Effect of canagliflozin on urinary albumin excretion in type 2 diabetic patients with microalbuminuria (pilot study) |
Date of disclosure of the study information | 2016/09/06 |
Last modified on | 2017/12/27 16:56:31 |
Effect of canagliflozin on urinary albumin excretion in type 2 diabetic patients with microalbuminuria (pilot study)
Effect of canagliflozin on microalbuminuria in type 2 diabetic patients
Effect of canagliflozin on urinary albumin excretion in type 2 diabetic patients with microalbuminuria (pilot study)
Effect of canagliflozin on microalbuminuria in type 2 diabetic patients
Japan |
Type 2 diabetic patients with microalbuminuria
Endocrinology and Metabolism |
Others
NO
To investigate the effect of canagliflozin on diabetic nephropathy in type 2 diabetic patients with microalbuminuria by evaluating 24-hr urine albumin excretion. In addition, several markers of renal impairment are exploratory studied.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Percent change in the 24-hour urine albumin excretion level (mg/day) from baseline to 12 weeks.
Changes or percent changes in the following markers from baseline to 12 weeks.
1) HbA1c, fasting blood glucose
2) Body weight, BMI
3) eGFR (by serum creatinine, serum cystatin C), creatinine clearance
4) Urinary albumin (first morning voids, creatinine ratio)
5) Tubular and glomerular damage marker: Urinary type IV collagen, urinary transferrin, urinary NAG, urinary L-FABP, urinary B2 microglobulin, urinary NGAL, urinary KIM-1, serum TNFR1, serum TNFR2
6) Inflammatory marker: Serum IL-18, Serum high-sensitivity C-reactive protein
7) Oxidative stress marker: Urinary 8-OHdG
8) Blood pressure, serum uric acid, urinary aldosterone, serum aldosterone, plasma renin activity
9) Hematocrit
10) Serum erythropoietin
11) Absolute change in the 24-hour urine albumin (mg/day)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Canagliflozin 100mg, once daily, before or after breakfast, oral administration
20 | years-old | <= |
75 | years-old | > |
Male and Female
1. Type 2 diabetes
2. Age >=20, 75> years on the date of submission of informed consent
3. Submission of written informed consent for participation in the study
The following criteria are confirmed by data available on the visit for eligibility confirmation.
4. HbA1c=<10%(NGSP)
In case of patients with age >=65, 75> years administered with SU and/or glinide, 6.5%=<HbA1c=<10%(NGSP)
5. Blood pressure: <140/90mmHg
6. Urinary albumin: 30.0-299.9mg/g.Cr (first morning voids)
7. eGFR>=45mL/min/1.73m2
1. Type 1 diabetes
2. The following drugs are administered (the date of submission of informed consent)SGLT2 inhibitor Insulin GLP-1receptor agonist
3. History of hypersensitivity to canagliflozin
4. Has severe ketosis, diabetic coma or semi-coma
5. Has severe infection, trauma or perioperative
6. Possible or definitive pregnant women or nursing mother
7. Has malignant tumor or suspicious for
8. Has urinary tract infection
9. Has NYHA class IV heart failure
10. Has severe anemia
11. Considered not eligible for the study by principal or other investigators due to other reasons
20
1st name | |
Middle name | |
Last name | Takeshi Osonoi |
Nakakinen clinic Medical Corporation Kensei-kai
Director
745-5, Nakadai, Naka, Ibaraki
029-353-2800
k-ofuchi@kensei-kai.com
1st name | |
Middle name | |
Last name | Kensuke Ofuchi |
Nakakinen clinic Medical Corporation Kensei-kai
department of clinical research
745-5, Nakadai, Naka, Ibaraki
029-353-2800
k-ofuchi@kensei-kai.com
Nakakinen clinic Medical Corporation Kensei-kai
Mitsubishi Tanabe Pharma Corporation
Profit organization
NO
2016 | Year | 09 | Month | 06 | Day |
Unpublished
Completed
2016 | Year | 08 | Month | 23 | Day |
2016 | Year | 09 | Month | 15 | Day |
2016 | Year | 09 | Month | 06 | Day |
2017 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027582
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