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

Primary Purpose

T2DM (Type 2 Diabetes Mellitus), Metformin, SGLT2-Inhibitors

Status

Recruiting

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Tofogliflozin

Metformin

About this trial

This is an interventional treatment trial for T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shinshu UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tofogliflozin

Metformin

Arm Description

Outcomes

Primary Outcome Measures

Urine albumin-to-creatinine ratio (UACR)

Change from baseline in urine albumin-to-creatinine ratio (UACR) after 52 weeks treatment.

Secondary Outcome Measures

Urine albumin-to-creatinine ratio (UACR)

Change from baseline in urine albumin-to-creatinine ratio (UACR) after 26 and 104 weeks treatment.

Urine albumin-to-creatinine ratio (UACR)

Change rates from baseline in urine albumin-to-creatinine ratio (UACR) after 26, 52 and 104weeks treatment.

Change slope in eGFR

HbA1c

Change in HbA1c

Body weight

Changes in body weight

Systolic / diastolic blood pressure

Changes in systolic / diastolic blood pressure

Total serum proteins

Changes in total serum proteins

Serum albumin

Changes in serum albumin

Uric acid

Changes in uric acid

Hematocrit

Changes in hematocrit

Hemoglobin

Changes in hemoglobin

Red blood cell count

Changes in red blood cell count

Pulse rate

Changes in pulse rate

Triglyceride

Changes in triglyceride

Low-density lipoprotein

Changes in low-density lipoprotein

High-density lipoprotein

Changes in high-density lipoprotein

Albuminuria class

Transition of albuminuria class

Full Information

NCT ID

NCT05469659

First Posted

July 15, 2022

Last Updated

July 21, 2022

Sponsor

Shinshu University

Collaborators

Kowa Company, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05469659

Brief Title

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

Acronym

TRUTH-DKD

Official Title

Effect of Tofogliflozin on Urine Albumin-to-Creatinine Ratio Compared to Metformin Hydrochloride in Diabetic Kidney Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 22, 2021 (Actual)

Primary Completion Date

October 30, 2025 (Anticipated)

Study Completion Date

October 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shinshu University

Collaborators

Kowa Company, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

T2DM (Type 2 Diabetes Mellitus), Metformin, SGLT2-Inhibitors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tofogliflozin

Arm Type

Experimental

Arm Title

Metformin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tofogliflozin

Intervention Description

Tofogliflozin 20 mg is orally administered once daily for 104 weeks before or after breakfast.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Urine albumin-to-creatinine ratio (UACR)

Description

Change from baseline in urine albumin-to-creatinine ratio (UACR) after 52 weeks treatment.

Time Frame

Up to 52 weeks

Secondary Outcome Measure Information:

Title

Urine albumin-to-creatinine ratio (UACR)

Description

Change from baseline in urine albumin-to-creatinine ratio (UACR) after 26 and 104 weeks treatment.

Time Frame

Up to 26 and 104 weeks

Title

Urine albumin-to-creatinine ratio (UACR)

Description

Change rates from baseline in urine albumin-to-creatinine ratio (UACR) after 26, 52 and 104weeks treatment.

Time Frame

Up to 26, 52 and 104 weeks

Title

Change slope in eGFR

Description

Change slope in eGFR

Time Frame

Up to 52 and 104 weeks

Title

HbA1c

Description

Change in HbA1c

Time Frame

Up to 52 and 104 weeks

Title

Body weight

Description

Changes in body weight

Time Frame

Up to 52 and 104 weeks

Title

Systolic / diastolic blood pressure

Description

Changes in systolic / diastolic blood pressure

Time Frame

Up to 52 and 104 weeks

Title

Total serum proteins

Description

Changes in total serum proteins

Time Frame

Up to 52 and 104 weeks

Title

Serum albumin

Description

Changes in serum albumin

Time Frame

Up to 52 and 104 weeks

Title

Uric acid

Description

Changes in uric acid

Time Frame

Up to 52 and 104 weeks

Title

Hematocrit

Description

Changes in hematocrit

Time Frame

Up to 52 and 104 weeks

Title

Hemoglobin

Description

Changes in hemoglobin

Time Frame

Up to 52 and 104 weeks

Title

Red blood cell count

Description

Changes in red blood cell count

Time Frame

Up to 52 and 104 weeks

Title

Pulse rate

Description

Changes in pulse rate

Time Frame

Up to 52 and 104 weeks

Title

Triglyceride

Description

Changes in triglyceride

Time Frame

Up to 52 and 104 weeks

Title

Low-density lipoprotein

Description

Changes in low-density lipoprotein

Time Frame

Up to 52 and 104 weeks

Title

High-density lipoprotein

Description

Changes in high-density lipoprotein

Time Frame

Up to 52 and 104 weeks

Title

Albuminuria class

Description

Transition of albuminuria class

Time Frame

Up to 104 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Koichiro Kuwahara, MD, PhD

Phone

+81-263-37-3191

kkuwah@shinshu-u.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Koichiro Kuwahara, MD, PhD

Organizational Affiliation

Shinshu University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Shinshu University

City

Matsumoto

State/Province

Nagano

ZIP/Postal Code

390-8621

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Koichiro Kuwahara, MD, PhD

Phone

+81-263-37-3191

kkuwah@shinshu-u.ac.jp

First Name & Middle Initial & Last Name & Degree

Masatoshi Minamisawa

Phone

+81-263-37-3191

nanchan7131@gmail.com

First Name & Middle Initial & Last Name & Degree

Koichiro Kuwahara, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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