Type 2 DiabetesPhase 3NCT07076056
Clinical Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2
A Phase 3 study testing DW1026C1, DW1026C2 and DW1026S in people with Type 2 Diabetes, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- DW1026C1, DW1026C2 and DW1026S
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Oct 2022to 19 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with Type2 Diabetes
- 19 ≤ Age ≤ 85
- 7.0% ≤ HbA1c ≤ 10.5%
Who cannot join
- Patients with a history of acute pancreatitis
- Patients with a history of pre-diabetic coma
- Patients with a history of diagnosis of malignant tumors within 5 years prior to visit 1
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yeouido St. Mary's Hospital The Catholic University
Seoul
About this study
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy
A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy
- Conditions
- Type 2 Diabetes
- Being tested
- DW1026C1, DW1026C2, DW1026S
- 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.
DW1026C1Drug
Sitagliptin 100mg+Empagliflozin 10mg
DW1026C2Drug
Sitagliptin 100mg+Empagliflozin 25mg
DW1026SDrug
Sitagliptin 100mg
| Study group | Role | What they receive |
|---|---|---|
| DW1026C1 & DW1026C2 placebo & DW1026S placebo | Experimental | Not described Receives: Drug: DW1026C1 |
| DW1026C1 placebo & DW1026C2 & DW1026S placebo | Experimental | Not described Receives: Drug: DW1026C2 |
| DW1026C1 placebo & DW1026C2 placebo & DW1026S | Placebo comparator | Not described Receives: Drug: DW1026S |
What is being measured
The primary outcome is the main question the study is designed to answer.
% change of HbA1c
% change of HbA1c in week 24 from baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2025
- Study start27 Oct 2022
- Primary completion4 Dec 2023
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076056
- Sponsor's protocol ID
- DW1026-301
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 21 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim S, Kim TN, Mok JO, Chung CH, Hwang YC, Cho HC, Won JC, Jeon E, Kang ES, Lee KY, Kim CH, Kwak SH, Park CY, Park KS, Kim SY, Lee JH, Lee SH, Cho DH, Kwon HS, Han KA. Efficacy and Safety of Fixed-Dose Combinations of Sitagliptin and Empagliflozin as Add-On to Metformin in Korean Patients With Type 2 Diabetes: A Randomised, Double-Blind, Multi-Centre, Placebo-Controlled, Phase III Trial. Diabetes Obes Metab. 2026 Jun;28(6):4847-4859. doi: 10.1111/dom.70669. Epub 2026 Mar 26.
PubMed 41883295
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy
- ClinicalTrials.gov ID
- NCT07076056
- Acronym / sponsor ID
- DW1026-301
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 21 Jul 2025 (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.
A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DW1026C1 & DW1026C2 placebo & DW1026S placebo | Experimental | Drug: DW1026C1 |
| DW1026C1 placebo & DW1026C2 & DW1026S placebo | Experimental | Drug: DW1026C2 |
| DW1026C1 placebo & DW1026C2 placebo & DW1026S | Placebo comparator | Drug: DW1026S |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are diagnosed with Type2 Diabetes
- 19 ≤ Age ≤ 85
- 7.0% ≤ HbA1c ≤ 10.5%
Key exclusion criteria (3 listed)
- Patients with a history of acute pancreatitis
- Patients with a history of pre-diabetic coma
- Patients with a history of diagnosis of malignant tumors within 5 years prior to visit 1
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 |
|---|---|---|
| DW1026C1Sitagliptin 100mg+Empagliflozin 10mg | Drug | DW1026C1 & DW1026C2 placebo & DW1026S placebo |
| DW1026C2Sitagliptin 100mg+Empagliflozin 25mg | Drug | DW1026C1 placebo & DW1026C2 & DW1026S placebo |
| DW1026SSitagliptin 100mg | Drug | DW1026C1 placebo & DW1026C2 placebo & DW1026S |
Primary outcome
% change of HbA1c
Time frame: 24 weeks
% change of HbA1c in week 24 from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2025.
- Derived from this study: PubMed 41883295Lim S, Kim TN, Mok JO, Chung CH, Hwang YC, Cho HC, Won JC, Jeon E, Kang ES, Lee KY, Kim CH, Kwak SH, Park CY, Park KS, Kim SY, Lee JH, Lee SH, Cho DH, Kwon HS, Han KA. Efficacy and Safety of Fixed-Dose Combinations of Sitagliptin and Empagliflozin as Add-On to Metformin in Korean Patients With Type 2 Diabetes: A Randomised, Double-Blind, Multi-Centre, Placebo-Controlled, Phase III Trial. Diabetes Obes Metab. 2026 Jun;28(6):4847-4859. doi: 10.1111/dom.70669. Epub 2026 Mar 26.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 DW1026C1, DW1026C2 and DW1026S in people with Type 2 Diabetes, run by Daewon 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% change of HbA1c (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07076056, which also lists 1 linked publication.
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 21 Jul 2025.