Type 2 Diabetic NephropathyPhase 3NCT06606093
Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients
A Phase 3 study testing DWP16001 0.3mg in people with Type 2 Diabetic Nephropathy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetic Nephropathy
- What is being tested?
- DWP16001 0.3mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Sep 2024to 31 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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:
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- 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
- Severe cerebrovascular diseases (e.g., stroke, cerebral infarction, cerebral hemorrhage)
- Individuals requiring treatment due to dehydration from continuous diarrhea or vomiting, or those at risk of fluid volume depletion
- Individuals unable to take medications orally, or with major gastrointestinal diseases or surgeries (e.g., gastrectomy, gastrointestinal bypass) that may affect drug absorption, distribution, metabolism, or excretion
- Individuals with positive results from the serology tests at the Screening Visit (Visit 1):
- Positive for HIV
- Positive for HBsAg with HBV DNA ≥ 2000 IU/mL
- Positive for Anti-HCV
- Individuals with severe liver dysfunction at the Screening Visit (Visit 1) as follows:
- AST or ALT \> 3 times the upper limit of normal
- Total bilirubin \> 2 times the upper limit of normal
- Individuals with more than a 25% change in eGFR between the Screening Visit (Visit 1) and the Baseline Visit (Visit 2)
- Individuals with clinically significant severe infections (e.g., those requiring continuous antibiotic or immunotherapy) or severe trauma, as determined by the investigator
- Individuals with a past or present diagnosis of malignant tumors (participation allowed if cured or if there has been no recurrence in the past 5 years)
- Individuals with a history of hypersensitivity to the active ingredient or components of the investigational drug
- Individuals with a history of alcohol or drug abuse within 12 months of the Screening Visit (Visit 1)
- Individuals taking ACE inhibitors, ARBs, or renin inhibitors (allowed if taken at a stable dose and regimen for more than 8 weeks prior to the Pre-Baseline Visit (Visit 1-1))
- Individuals requiring continuous systemic corticosteroid treatment (use of topical corticosteroids for joint, nasal, ocular, or inhalation administration, or temporary systemic corticosteroid use for contrast agent allergies or adverse event treatment/prevention is allowed)
- Women of childbearing potential who do not agree to use appropriate contraception* during the trial A. Women over 50 years of age who have been amenorrheic for at least 12 months after discontinuing exogenous hormone therapy B. Women with a history of irreversible surgical infertility (e.g., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) (tubal ligation not allowed) C. Women under 50 years of age who have been amenorrheic for at least 12 months after discontinuing exogenous hormone therapy and whose luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within postmenopausal ranges according to the investigational site\'s standards Appropriate contraception: Complete abstinence, tubal ligation, hormonal contraceptives with no known drug interactions [levonorgestrel intrauterine system (IUS) (Mirena), medroxyprogesterone injection], copper intrauterine devices, and partner's vasectomy. Periodic abstinence (e.g., calendar methods, basal body temperature method, or post-ovulation method) and withdrawal are not considered acceptable contraceptive methods.
- Men who have not undergone vasectomy and who do not agree to use barrier contraception (e.g., condoms), or whose partners do not agree to use appropriate contraception during the trial
- Pregnant or breastfeeding women, or women with a positive pregnancy test result at the Screening Visit (Visit 1) or Baseline Visit (Visit 2)
- Individuals who received investigational drugs within 8 weeks prior to the Screening Visit (Visit 1) (participation allowed if no investigational drug was administered or if involved in a non-interventional observational study)
- Other individuals deemed inappropriate for trial participation at the discretion of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Korea university ansan hospital
Ansan, Gyeongggi-do, 15355
Nan Hee Kim, 82-2-550-8016, yeonseo@daewoong.co.kr
About this study
Official title: 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)
This study aims to evaluate the efficacy and safety of DWP16001 in type 2 diabetic nephropathy with moderate renal impairment patients (CKD stage 3)
Read the 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.
- Conditions
- Type 2 Diabetic Nephropathy
- Being tested
- DWP16001 Placebo, DWP16001 0.3mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP16001 PlaceboDrug
1 tablet, Orally, Once daily single dose
DWP16001 0.3mgDrug
1 tablet, Orally, Once daily single dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: DWP16001 Placebo |
| Enavogliflozin 0.3 mg once daily | Experimental | Not described Receives: Drug: DWP16001 0.3mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c at Week 24 from Baseline after Randomization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start23 Sep 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606093
- Sponsor's protocol ID
- DW_DWP16001309
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06606093
- Acronym / sponsor ID
- DW_DWP16001309
- Conditions
- Type 2 Diabetic Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: DWP16001 Placebo |
| Enavogliflozin 0.3 mg once daily | Experimental | Drug: DWP16001 0.3mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (37 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWP16001 Placebo1 tablet, Orally, Once daily single dose | Drug | Placebo |
| DWP16001 0.3mg1 tablet, Orally, Once daily single dose | Drug | Enavogliflozin 0.3 mg once daily |
Primary outcome
Change in HbA1c at Week 24 from Baseline after Randomization
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWP16001 0.3mg in people with Type 2 Diabetic Nephropathy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeonseo Choi (82-2-550-8016, yeonseo@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c at Week 24 from Baseline after Randomization (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.