Comparing Tofogliflozin and Metformin for Kidney Health in Diabetes
Effect of Tofogliflozin on Urine Albumin-to-Creatinine Ratio Compared to Metformin Hydrochloride in Diabetic Kidney Disease
This study is testing whether tofogliflozin can better improve kidney health compared to metformin in people with type 2 diabetes and chronic kidney disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Shinshu University Academic / other |
| Locations | 1 site (Matsumoto, Nagano) |
| Trial ID | NCT05469659 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, open-label study evaluates the effectiveness of tofogliflozin, an SGLT2 inhibitor, in improving urine albumin-to-creatinine ratio (UACR) compared to metformin in patients with type 2 diabetes and chronic kidney disease (CKD). Participants will be randomly assigned to receive either tofogliflozin or metformin, with stratification based on UACR levels, estimated glomerular filtration rate (eGFR), and age. The primary outcome is the change in UACR after 52 weeks of treatment, along with secondary outcomes including changes in eGFR, HbA1c, body weight, and various blood parameters.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 years or older with type 2 diabetes, an HbA1c between 6.5% and 9.0%, and specific UACR and eGFR criteria.
Not a fit: Patients with severe kidney impairment (eGFR below 30 mL/min/1.73m2) or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for managing kidney health in patients with type 2 diabetes.
How similar studies have performed: Other studies have shown positive outcomes with SGLT2 inhibitors in diabetic kidney disease, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 2 diabetic patients * Patients aged 20 years or older at the time of obtaining consent * Patients with HbA1c 6.5 or more and 9.0% or less within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor / metformin) * Patients who have been judged by their doctor to need a diabetic drug when they are first seen, or who have already taken a diabetic drug and have decided that it is necessary to add one diabetic drug. * Patients who have been receiving RAS inhibitors (ARB, ARNI, ACE inhibitors, direct renin inhibitors) for 4 weeks or longer * Patients with eGFR of 30 or more (mL / min / 1.73m2) within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor / metformin) * Patients with urinary albumin / creatinine ratio (UACR) of 30 or more and less than 2000 (mg / gCr) (4 weeks or more without taking SGLT2 inhibitor / metformin) within 13 weeks before obtaining consent Evaluate by inspection value) * Patients for whom written consent was obtained based on the patient's free will after receiving sufficient explanation for participation in this study Exclusion Criteria: * Patients receiving treatment with SGLT2 inhibitor or metformin within 13 weeks before obtaining consent * Dialysis patient * Patients with a history of severe hypoglycemia * Patients with hypersensitivity to SGLT2 inhibitor or metformin * Pregnant women, lactating patients, and patients who wish to raise children * Patients with BMI of 35 kg / m2 or more based on the latest measured values within 13 weeks before obtaining consent * Patients who are contraindicated for the study drug * Other patients who the attending physician deems inappropriate as a subject
Where this trial is running
Matsumoto, Nagano
- Shinshu University — Matsumoto, Nagano, Japan (Recruiting)
Study contacts
- Study coordinator: Koichiro Kuwahara, MD, PhD
- Email: kkuwah@shinshu-u.ac.jp
- Phone: +81-263-37-3191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.