Metformin Clinical Trial
— TRUTH-DKDOfficial title:
Effect of Tofogliflozin on Urine Albumin-to-Creatinine Ratio Compared to Metformin Hydrochloride in Diabetic Kidney Disease
This multicenter, randomized, open-label, controlled study will assess the efficacy of the SGLT2 inhibitor tofogliflozin on Urine Albumin-to-Creatinine Ratio (UACR) compared to metformin in patients with type 2 diabetes with chronic kidney disease (CKD).
Status | Recruiting |
Enrollment | 120 |
Est. completion date | October 30, 2026 |
Est. primary completion date | October 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Shinshu University | Matsumoto | Nagano |
Lead Sponsor | Collaborator |
---|---|
Shinshu University | Kowa Company, Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine albumin-to-creatinine ratio (UACR) | Change from baseline in urine albumin-to-creatinine ratio (UACR) after 52 weeks treatment. | Up to 52 weeks | |
Secondary | Urine albumin-to-creatinine ratio (UACR) | Change from baseline in urine albumin-to-creatinine ratio (UACR) after 26 and 104 weeks treatment. | Up to 26 and 104 weeks | |
Secondary | Urine albumin-to-creatinine ratio (UACR) | Change rates from baseline in urine albumin-to-creatinine ratio (UACR) after 26, 52 and 104weeks treatment. | Up to 26, 52 and 104 weeks | |
Secondary | Change slope in eGFR | Change slope in eGFR | Up to 52 and 104 weeks | |
Secondary | HbA1c | Change in HbA1c | Up to 52 and 104 weeks | |
Secondary | Body weight | Changes in body weight | Up to 52 and 104 weeks | |
Secondary | Systolic / diastolic blood pressure | Changes in systolic / diastolic blood pressure | Up to 52 and 104 weeks | |
Secondary | Total serum proteins | Changes in total serum proteins | Up to 52 and 104 weeks | |
Secondary | Serum albumin | Changes in serum albumin | Up to 52 and 104 weeks | |
Secondary | Uric acid | Changes in uric acid | Up to 52 and 104 weeks | |
Secondary | Hematocrit | Changes in hematocrit | Up to 52 and 104 weeks | |
Secondary | Hemoglobin | Changes in hemoglobin | Up to 52 and 104 weeks | |
Secondary | Red blood cell count | Changes in red blood cell count | Up to 52 and 104 weeks | |
Secondary | Pulse rate | Changes in pulse rate | Up to 52 and 104 weeks | |
Secondary | Triglyceride | Changes in triglyceride | Up to 52 and 104 weeks | |
Secondary | Low-density lipoprotein | Changes in low-density lipoprotein | Up to 52 and 104 weeks | |
Secondary | High-density lipoprotein | Changes in high-density lipoprotein | Up to 52 and 104 weeks | |
Secondary | Albuminuria class | Transition of albuminuria class | Up to 104 weeks |
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