Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

This study aims to evaluate the efficacy and safety of DWP16001 in type 2 diabetic nephropathy with moderate renal impairment patients (CKD stage 3)

Eligibility criteria

Qualifiers

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%

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • DWP16001 Placebo
  • DWP16001 0.3mg

Treatment groups

348 Participants
are divided into 2 treatment groups