MedTrace Logo

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

NCT05469659 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-07-22

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

Tofogliflozin

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

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.

Sponsors & Collaborators

  • Kowa Company, Ltd.

    collaborator INDUSTRY

  • Shinshu University

    lead OTHER

Principal Investigators

  • Koichiro Kuwahara, MD, PhD · Shinshu University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2025-10-30
Completion
2026-10-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469659 on ClinicalTrials.gov