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

ConditionsT2DM (Type 2 Diabetes Mellitus)MetforminSGLT2-Inhibitors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorShinshu University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tofogliflozin

    Drug

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

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: TofogliflozinExperimental treatment 1 intervention
Group B: MetforminActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Urine albumin-to-creatinine ratio (UACR)

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

Time frame
Up to 52 weeks

Secondary outcomes

1

Urine albumin-to-creatinine ratio (UACR)

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

Time frame
Up to 26 and 104 weeks
2

Urine albumin-to-creatinine ratio (UACR)

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
3

Change slope in eGFR

Change slope in eGFR

Time frame
Up to 52 and 104 weeks
4

HbA1c

Change in HbA1c

Time frame
Up to 52 and 104 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shinshu University

Lead sponsor

Kowa Company, Ltd.

Collaborator

Source ClinicalTrials.gov
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