Effect of canagliflozin on urinary albumin excretion in type 2 diabetic patients with microalbuminuria (pilot study)

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023959

Enrollment

Registered

2016-09-06

Start date

2016-09-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetic patients with microalbuminuria

Interventions

Canagliflozin 100mg, once daily, before or after breakfast, oral administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Percent change in the 24-hour urine albumin excretion level (mg/day) from baseline to 12 weeks.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactKensuke Ofuchi

Nakakinen clinic Medical Corporation Kensei-kai department of clinical research

k-ofuchi@kensei-kai.com029-353-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026