Diabetes MellitusPhase 4NCT05743907
Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control
A Phase 4 study testing DA-2811 and Forxiga in people with Diabetes Mellitus, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- DA-2811 and Forxiga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Apr 2023to 10 Mar 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with 7.0%≤HbA1c≤10.0% at screening
- Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening
- Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
- Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
Who cannot join
- Subjects with fasting plasma glucose≥240mg/dL at screening
- Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- Subject with ALT and AST 3 times or higher than upper normal range
- Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si
About this study
Official title: A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control
This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control
- Conditions
- Diabetes Mellitus
- Being tested
- DA-2811, Forxiga
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-2811Drug
DA-2811 Group: DA-2811 + Forxiga placebo
ForxigaDrug
Forxiga Group: Forxiga + DA-2811 placebo
| Study group | Role | What they receive |
|---|---|---|
| DA-2811 | Experimental | DA-2811 + Forxiga placebo Receives: Drug: DA-2811 |
| Forxiga | Active comparator | Forxiga + DA-2811 placebo Receives: Drug: Forxiga |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c(%)
Measured: Change from baseline at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start25 Apr 2023
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743907
- Sponsor's protocol ID
- DA2811_DM_IV
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT05743907
- Acronym / sponsor ID
- DA2811_DM_IV
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 24 Feb 2023 (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 is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-2811 | Experimental | Drug: DA-2811DA-2811 + Forxiga placebo |
| Forxiga | Active comparator | Drug: ForxigaForxiga + DA-2811 placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with 7.0%≤HbA1c≤10.0% at screening
- Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening
- Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
- Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
Key exclusion criteria (4 listed)
- Subjects with fasting plasma glucose≥240mg/dL at screening
- Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- Subject with ALT and AST 3 times or higher than upper normal range
- Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening
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 |
|---|---|---|
| DA-2811DA-2811 Group: DA-2811 + Forxiga placebo | Drug | DA-2811 |
| ForxigaForxiga Group: Forxiga + DA-2811 placebo | Drug | Forxiga |
Primary outcome
HbA1c(%)
Time frame: Change from baseline at 24 weeks
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 14 Mar 2025.
- Individual participant dataSharing planned: Yes
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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 4 study testing DA-2811 and Forxiga in people with Diabetes Mellitus, run by Dong-A ST 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 4 inclusion and 4 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 14 Mar 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
HbA1c(%) (time frame: Change from baseline at 24 weeks). 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 14 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.