T2DM (Type 2 Diabetes Mellitus)Phase 3NCT07619833
To Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing DWP16001 and DWC202518 in people with T2DM (Type 2 Diabetes Mellitus), run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study aims to evaluate the efficacy and safety of initial combination therapy with DWP16001 and DWC202518 compared to DWP16001 monotherapy and DWC202518 monotherapy in patients with Type 2 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- DWP16001 and DWC202518
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2026to Nov 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to cooperate and participate in this clinical study after understanding the study explanation, and capable of voluntarily signing the written informed consent form before any assessments are performed.
- Male or female adult aged ≥18 and ≤80 years. Note: The minimum legal age of adult dependent on local regulations. The legal age of adult in Korea is 19 years, while in Indonesia, it is 18 years.
- Have been diagnosed with T2DM based on American Diabetes Association (ADA) guidelines (2025) before screening.
- Participants must meet one of the following conditions at Visit 1 (Screening):
- Have an HbA1c ≥7.5% and ≤11% at Visit 1 (Screening) and either have never taken oral anti-diabetic medication since diagnosis or have not taken any oral anti-diabetic medication within 12 weeks prior to screening.
- Have an HbA1c ≥6.5% and ≤10.5% at Visit 1 (Screening) and are currently taking one type of oral anti-diabetic medication at screening.
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- Note: The HbA1c level at Visit 1 can be measured by the local laboratory.
- Have an FPG <15 mmol/L (270 mg/dL), as measured by local laboratory at Visit 1.
- Participants must meet all the following conditions at Visit 2 (Baseline):
- Have an HbA1c ≥7.5% and ≤11%, as measured by the central laboratory at Visit 1-1.
- Have an FPG <15 mmol/L (270 mg/dL), as measured by central laboratory at Visit 1-1.
- Have a BMI ≥20 kg/m2 and ≤45 kg/m2 at screening.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening. WOCBP and their partners must use highly effective, medically accepted contraception to prevent pregnancy and must not have pregnancy or fertility plans throughout the study and for at least 4 weeks after the last dose of study medication
- Male participants must agree to use highly effective, medically accepted contraception and refrain from donating sperm throughout the study and for at least 4 weeks after the last dose of study medication
Who cannot join
- Type 1 diabetes mellitus, congenital diabetes, secondary diabetes, or history of diabetic ketoacidosis, diabetic coma, or precoma
- Severe diabetes-related complications, including proliferative diabetic retinopathy, advanced nephropathy, or severe diabetic neuropathy
- Clinically significant renal disease, severe gastrointestinal disease or surgery affecting gastrointestinal absorption, pancreatitis, clinically significant urinary/genital infections, dehydration requiring treatment, or uncontrolled thyroid disease
- Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening, including myocardial infarction, unstable angina, stroke, clinically significant arrhythmia requiring treatment, or New York Heart Association (NYHA) class III-IV heart failure
- Active or untreated malignancy, or clinically significant malignancy within the previous 5 years (except adequately treated localized skin cancers or in situ carcinomas)
- Hematologic conditions that may interfere with HbA1c measurement
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- Clinically significant endocrine disorders affecting glucose metabolism
- Known or suspected hypersensitivity to study treatment or related products
- Screening laboratory abnormalities including:
- ㆍ Fasting C-peptide ≤0.60 ng/mL ㆍ Triglycerides >500 mg/dL ㆍ eGFR <60 mL/min/1.73m² ㆍ AST or ALT ≥3× upper limit of normal (ULN), or total bilirubin ≥2× ULN
- Positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection meeting protocol-defined criteria
- Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg)
- Prior use of prohibited antidiabetic therapies, including prior antidiabetic combination therapy, thiazolidinediones within 12 weeks, or GLP-1 receptor agonists or insulin within 6 months before screening
- Use of weight-loss medications within 3 months prior to screening or between screening and baseline
- Use of systemic corticosteroids at pharmacologic doses within 1 month prior to screening or between screening and baseline
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
Kangbuk Samsung Hospital
Seoul
Cheol-Young Park, 82-2-550-8016, yoonhye@daewoong.co.kr
About this study
Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus
This study aims to evaluate the efficacy and safety of initial combination therapy with DWP16001 and DWC202518 compared to DWP16001 monotherapy and DWC202518 monotherapy in patients with Type 2 Diabetes Mellitus
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- DWP16001, DWC202518, Placebo of DWP16001, Placebo of DWC202518
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP16001Drug
DWP16001 0.3mg, Tablets, Orally, Once daily
DWC202518Drug
DWC202518, Tablets, Orally, Once daily
Placebo of DWP16001Drug
DWP16001 placebo-matching tablets
Placebo of DWC202518Drug
DWC202518 placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Combination Group | Experimental | Not described Receives: Drug: DWP16001; Drug: DWC202518 |
| DWP16001 monotherapy Group | Experimental | Not described Receives: Drug: DWP16001; Drug: Placebo of DWC202518 |
| DWC202518 monotherapy Group | Experimental | Not described Receives: Drug: DWC202518; Drug: Placebo of DWP16001 |
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 posted2 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies 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
- 510 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
- NCT07619833
- Sponsor's protocol ID
- DW_DWP16001311
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 2 Jun 2026
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07619833
- Acronym / sponsor ID
- DW_DWP16001311
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 2 Jun 2026 (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 initial combination therapy with DWP16001 and DWC202518 compared to DWP16001 monotherapy and DWC202518 monotherapy in patients with Type 2 Diabetes Mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination Group | Experimental | Drug: DWP16001, Drug: DWC202518 |
| DWP16001 monotherapy Group | Experimental | Drug: DWP16001, Drug: Placebo of DWC202518 |
| DWC202518 monotherapy Group | Experimental | Drug: DWC202518, Drug: Placebo of DWP16001 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Able and willing to cooperate and participate in this clinical study after understanding the study explanation, and capable of voluntarily signing the written informed consent form before any assessments are performed.
- Male or female adult aged ≥18 and ≤80 years. Note: The minimum legal age of adult dependent on local regulations. The legal age of adult in Korea is 19 years, while in Indonesia, it is 18 years.
- Have been diagnosed with T2DM based on American Diabetes Association (ADA) guidelines (2025) before screening.
- Participants must meet one of the following conditions at Visit 1 (Screening):
- Note: The HbA1c level at Visit 1 can be measured by the local laboratory.
Key exclusion criteria (15 listed)
- Type 1 diabetes mellitus, congenital diabetes, secondary diabetes, or history of diabetic ketoacidosis, diabetic coma, or precoma
- Severe diabetes-related complications, including proliferative diabetic retinopathy, advanced nephropathy, or severe diabetic neuropathy
- Clinically significant renal disease, severe gastrointestinal disease or surgery affecting gastrointestinal absorption, pancreatitis, clinically significant urinary/genital infections, dehydration requiring treatment, or uncontrolled thyroid disease
- Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening, including myocardial infarction, unstable angina, stroke, clinically significant arrhythmia requiring treatment, or New York Heart Association (NYHA) class III-IV heart failure
- Active or untreated malignancy, or clinically significant malignancy within the previous 5 years (except adequately treated localized skin cancers or in situ carcinomas)
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 |
|---|---|---|
| DWP16001DWP16001 0.3mg, Tablets, Orally, Once daily | Drug | Combination Group, DWP16001 monotherapy Group |
| DWC202518DWC202518, Tablets, Orally, Once daily | Drug | Combination Group, DWC202518 monotherapy Group |
| Placebo of DWP16001DWP16001 placebo-matching tablets | Drug | DWC202518 monotherapy Group |
| Placebo of DWC202518DWC202518 placebo-matching tablets | Drug | DWP16001 monotherapy Group |
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 2 Jun 2026.
- 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 and DWC202518 in people with T2DM (Type 2 Diabetes Mellitus), 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 14 inclusion and 15 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 2 Jun 2026. 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. 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 Yoonhye Jeong (82-2-550-8016, yoonhye@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 2 Jun 2026.