A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Phase 3 Clinical Trial and Open-label Extension Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients (CKD Stage 3)

Daewoong Pharmaceutical Co. LTD.1 site in 1 country348 target enrollmentSeptember 23, 2024

ConditionsType 2 Diabetic Nephropathy

InterventionsDWP16001 Placebo DWP16001 0.3mg

DrugsDWP16001 Placebo DWP16001 0.3mg

Overview

Phase: Phase 3
Intervention: DWP16001 Placebo
Conditions: Type 2 Diabetic Nephropathy
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 348
Locations: 1
Primary Endpoint: Change in HbA1c at Week 24 from Baseline after Randomization
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

The drug in this study is called enavogliflozin. Enavogliflozin, as a once-daily oral therapy for type 2 diabetes. This study aiming to evaluate its efficacy in patients with type 2 diabetic nephropathy with moderate renal impairment patients.

Registry

clinicaltrials.gov

Start Date

September 23, 2024

End Date

January 31, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).
•Patients whose test results from the investigational site\'s laboratory at the Screening Visit (Visit 1) meet all of the following criteria:
•HbA1c: 7.0% ≤ HbA1c ≤ 10.0%
•eGFR: 30 ≤ eGFR \< 60 ml/min/1.73 m² (using the CKD-EPI formula)
•Patients who are willing to cooperate and participate in this clinical trial after understanding the explanation of the trial and who can voluntarily sign the informed consent form.
•Patients whose central laboratory results from the sample collected at the Pre-Baseline Visit (Visit 1-1) show an eGFR of 30 ≤ eGFR \< 60 ml/min/1.73 m² (using the CKD-EPI formula).
•Patients whose central laboratory results from the sample collected at the Pre-Baseline Visit (Visit 1-1) show an HbA1c of 7.0% ≤ HbA1c ≤ 10.0%.
•Patients with a medication compliance rate of 70-130% during the Run-in Period, as confirmed at the Baseline Visit (Visit 2).

Exclusion Criteria

•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)
•Individuals who have received cytotoxic treatment, immunosuppressive therapy, or immunotherapy for renal disease within 6 months of the Baseline Visit (Visit 2)
•Individuals diagnosed with or treated for any of the following diseases within 3 months of the Screening Visit (Visit 1), as determined by the investigator to be clinically significant:
•Severe heart disease \[heart failure (NYHA class III and IV), ischemic heart disease (angina, myocardial infarction), peripheral vascular disease, individuals who have undergone percutaneous transluminal coronary angioplasty or coronary artery bypass grafting\]
•\* NYHA class:
•Class I: No limitation on physical activity; no symptoms during ordinary activities
•Class II: Slight limitation on physical activity; no symptoms at rest, but symptoms occur during ordinary activities