This study aims to evaluate the efficacy and safety of DWP16001 in type 2 diabetic nephropathy with moderate renal impairment patients (CKD stage 3)
Men and women aged 19 years or older as of the date of written consent.
Patients with type 2 diabetes who have been on up to 3 antidiabetic medications at a stable dosage and regimen for at least 8 weeks prior to the Pre-Baseline Visit (Visit 1-1). For insulin, a fluctuation of within 10% during the 8 weeks prior to the Pre-Baseline Visit (Visit 1-1) is allowed.
Patients with a BMI of 18 to 45 kg/m² at the Screening Visit (Visit 1).
HbA1c: 7.0% ≤ HbA1c ≤ 10.0%
Individuals diagnosed with renal diseases other than diabetic chronic kidney disease
Patients with uncontrolled hypertension (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)
Individuals diagnosed with type 1 diabetes (insulin-dependent diabetes) or diabetic ketoacidosis
Individuals who are undergoing dialysis at the time of the Screening Visit (Visit 1) or have a history of renal transplantation or medically significant renal disease/surgery (e.g., renal vascular occlusive disease, nephrectomy)
Parallel
DWP16001 Placebo
Drug1 tablet, Orally, Once daily single dose
DWP16001 0.3mg
Drug1 tablet, Orally, Once daily single dose
Change in HbA1c at Week 24 from Baseline after Randomization
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
