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Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD) (TRUTH-DKD)

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ClinicalTrials.gov Identifier: NCT05469659
Recruitment Status : Recruiting
First Posted : July 22, 2022
Last Update Posted : July 22, 2022
Sponsor:
Collaborator:
Kowa Company, Ltd.
Information provided by (Responsible Party):
Koichiro Kuwahara, Shinshu University

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
T2DM (Type 2 Diabetes Mellitus) Metformin SGLT2-Inhibitors Drug: Tofogliflozin Drug: Metformin Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Tofogliflozin on Urine Albumin-to-Creatinine Ratio Compared to Metformin Hydrochloride in Diabetic Kidney Disease
Actual Study Start Date : September 22, 2021
Estimated Primary Completion Date : October 30, 2025
Estimated Study Completion Date : October 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tofogliflozin Drug: Tofogliflozin
Tofogliflozin 20 mg is orally administered once daily for 104 weeks before or after breakfast.
Active Comparator: Metformin Drug: Metformin
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.


Outcome Measures
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Primary Outcome Measures :
  1. Urine albumin-to-creatinine ratio (UACR) [ Time Frame: Up to 52 weeks ]
    Change from baseline in urine albumin-to-creatinine ratio (UACR) after 52 weeks treatment.


Secondary Outcome Measures :
  1. Urine albumin-to-creatinine ratio (UACR) [ Time Frame: Up to 26 and 104 weeks ]
    Change from baseline in urine albumin-to-creatinine ratio (UACR) after 26 and 104 weeks treatment.

  2. Urine albumin-to-creatinine ratio (UACR) [ Time Frame: Up to 26, 52 and 104 weeks ]
    Change rates from baseline in urine albumin-to-creatinine ratio (UACR) after 26, 52 and 104weeks treatment.

  3. Change slope in eGFR [ Time Frame: Up to 52 and 104 weeks ]
    Change slope in eGFR

  4. HbA1c [ Time Frame: Up to 52 and 104 weeks ]
    Change in HbA1c

  5. Body weight [ Time Frame: Up to 52 and 104 weeks ]
    Changes in body weight

  6. Systolic / diastolic blood pressure [ Time Frame: Up to 52 and 104 weeks ]
    Changes in systolic / diastolic blood pressure

  7. Total serum proteins [ Time Frame: Up to 52 and 104 weeks ]
    Changes in total serum proteins

  8. Serum albumin [ Time Frame: Up to 52 and 104 weeks ]
    Changes in serum albumin

  9. Uric acid [ Time Frame: Up to 52 and 104 weeks ]
    Changes in uric acid

  10. Hematocrit [ Time Frame: Up to 52 and 104 weeks ]
    Changes in hematocrit

  11. Hemoglobin [ Time Frame: Up to 52 and 104 weeks ]
    Changes in hemoglobin

  12. Red blood cell count [ Time Frame: Up to 52 and 104 weeks ]
    Changes in red blood cell count

  13. Pulse rate [ Time Frame: Up to 52 and 104 weeks ]
    Changes in pulse rate

  14. Triglyceride [ Time Frame: Up to 52 and 104 weeks ]
    Changes in triglyceride

  15. Low-density lipoprotein [ Time Frame: Up to 52 and 104 weeks ]
    Changes in low-density lipoprotein

  16. High-density lipoprotein [ Time Frame: Up to 52 and 104 weeks ]
    Changes in high-density lipoprotein

  17. Albuminuria class [ Time Frame: Up to 104 weeks ]
    Transition of albuminuria class


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05469659


Contacts
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Contact: Koichiro Kuwahara, MD, PhD +81-263-37-3191 kkuwah@shinshu-u.ac.jp

Locations
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Japan
Shinshu University Recruiting
Matsumoto, Nagano, Japan, 390-8621
Contact: Koichiro Kuwahara, MD, PhD    +81-263-37-3191    kkuwah@shinshu-u.ac.jp   
Contact: Masatoshi Minamisawa    +81-263-37-3191    nanchan7131@gmail.com   
Principal Investigator: Koichiro Kuwahara, MD, PhD         
Sponsors and Collaborators
Shinshu University
Kowa Company, Ltd.
Investigators
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Study Chair: Koichiro Kuwahara, MD, PhD Shinshu University School of Medicine
More Information
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Responsible Party: Koichiro Kuwahara, MD, PhD, Professor, Shinshu University
ClinicalTrials.gov Identifier: NCT05469659    
Other Study ID Numbers: 21-02
jRCTs031210339 ( Registry Identifier: jRCT )
First Posted: July 22, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus, Type 2
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Diabetes Complications
Metformin
6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action