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

NCT06606093 | Not Yet Recruiting Phase 3

• 1 other identifier: DW_DWP16001309
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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)

Conditions

Type 2 Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c at Week 24 from Baseline after Randomization

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: DWP16001 Placebo

Enavogliflozin 0.3 mg once daily

EXPERIMENTAL

Drug: DWP16001 0.3mg

Interventions

DWP16001 Placebo DRUG

1 tablet, Orally, Once daily single dose

Placebo

DWP16001 0.3mg DRUG

1 tablet, Orally, Once daily single dose

Enavogliflozin 0.3 mg once daily

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Class III: Marked limitation on physical activity; no symptoms at rest, but symptoms occur with less than ordinary activities
• Class IV: Symptoms present even at rest, and worsened by any physical activity
• Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic or mitral valve stenosis
• Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, arrhythmia
• Transient ischemic attack

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Korea university ansan hospital

Ansan, Gyeongggi-do, 15355, South Korea

Location

MeSH Terms

Interventions

Enavogliflozin

Central Study Contacts

Yeonseo Choi

CONTACT

82-2-550-8016; yeonseo@daewoong.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 20, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)