Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| jRCTs031210339 | Registry Identifier | jRCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kowa Company, Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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).
Eligible participants will be randomly assigned (1:1) to tofogliflozin or metformin with stratification based on UACR (<300 mg/gCr,≧300mg/gCr), an estimated glomerular filtration rate (eGFR) (<60mL/min/1.73m2, ≧60 mL/min/1.73m2), and age (<65 years old, ≧65 years old). The primary end point is change in urine albumin-to-creatinine ratio (UACR) from baseline after 52 weeks treatment. Changes in eGFR, HbA1c, body weight, systolic blood pressure, diastolic blood pressure, total serum proteins, serum albumin, uric acid, hematocrit, hemoglobin, red blood cell count, pulse rate, triglyceride, low-density lipoprotein, high-density lipoprotein and albuminuria class transition rate will also be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofogliflozin | Experimental |
| |
| Metformin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofogliflozin | Drug | Tofogliflozin 20 mg is orally administered once daily for 104 weeks before or after breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine albumin-to-creatinine ratio (UACR) | Change from baseline in urine albumin-to-creatinine ratio (UACR) after 52 weeks treatment. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Urine albumin-to-creatinine ratio (UACR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Koichiro Kuwahara, MD, PhD | Contact | +81-263-37-3191 | kkuwah@shinshu-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Koichiro Kuwahara, MD, PhD | Shinshu University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shinshu University | Recruiting | Matsumoto | Nagano | 390-8621 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41252113 | Derived | Kimura K, Takagi Y, Harada M, Ueda S, Minamisawa M, Sonoda K, Oiwa A, Yazaki Y, Sakurai S, Tomita T, Kaneko K, Yamamoto K, Takama N, Momose S, Inobe Y, Nogi K, Koshikawa M, Misawa T, Kasai T, Tsutsui H, Watanabe N, Yamazaki K, Miyamoto T, Midorikawa T, Usui T, Saigusa T, Motoki H, Saito Y, Kamijo Y, Komatsu M, Kuwahara K. Effect of Tofogliflozin on Urinary Albumin-to-Creatinine Ratio vs. Metformin in Diabetic Kidney Disease: Rationale and Study Protocol of the TRUTH-DKD Trial. Diabetes Ther. 2026 Jan;17(1):149-163. doi: 10.1007/s13300-025-01822-8. Epub 2025 Nov 18. | |
| 38837240 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C575086 | 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Metformin | Drug | Metformin is started at 500 mg daily and orally administered in 2 to 3 divided doses immediately before or after meals. The dose during the maintenance period is determined by observing the effect, but is usually 750 to 1,500 mg daily. Metformin is orally administered for 104 weeks throughout post-start period. The dose may be adjusted according to the patient's condition, but the maximum daily dose should be 2,250 mg. |
|
Change rates from baseline in urine albumin-to-creatinine ratio (UACR) after 26, 52 and 104weeks treatment.
| Up to 26, 52 and 104 weeks |
| Change slope in eGFR | Change slope in eGFR | Up to 52 and 104 weeks |
| HbA1c | Change in HbA1c | Up to 52 and 104 weeks |
| Body weight | Changes in body weight | Up to 52 and 104 weeks |
| Systolic / diastolic blood pressure | Changes in systolic / diastolic blood pressure | Up to 52 and 104 weeks |
| Total serum proteins | Changes in total serum proteins | Up to 52 and 104 weeks |
| Serum albumin | Changes in serum albumin | Up to 52 and 104 weeks |
| Uric acid | Changes in uric acid | Up to 52 and 104 weeks |
| Hematocrit | Changes in hematocrit | Up to 52 and 104 weeks |
| Hemoglobin | Changes in hemoglobin | Up to 52 and 104 weeks |
| Red blood cell count | Changes in red blood cell count | Up to 52 and 104 weeks |
| Pulse rate | Changes in pulse rate | Up to 52 and 104 weeks |
| Triglyceride | Changes in triglyceride | Up to 52 and 104 weeks |
| Low-density lipoprotein | Changes in low-density lipoprotein | Up to 52 and 104 weeks |
| High-density lipoprotein | Changes in high-density lipoprotein | Up to 52 and 104 weeks |
| Albuminuria class | Transition of albuminuria class | Up to 104 weeks |
| Derived |
| El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2. |
| D004700 | Endocrine System Diseases |