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Compares treatment options for T2DM (Type 2 Diabetes Mellitus)
Official title Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)
ClinicalTrials.gov ID: NCT05469659
What this study is testing
What is Tofogliflozin?
Tofogliflozin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for t2dm (type 2 diabetes mellitus).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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...
- 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...
- Patients who have been receiving RAS inhibitors (ARB, ARNI, ACE inhibitors, direct renin inhibitors) for 4 weeks or longer
You likely can't join if
- 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
See the full eligibility 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...
- Patients for whom written consent was obtained based on the patient's free will after receiving sufficient explanation for participation in this study
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Matsumoto, Nagano, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Matsumoto, Nagano, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.