Type 2 DiabetesPhase 3NCT06290349
Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
A Phase 3 study testing DA5221-T1, DA5221-T2 and DA5221-B1 in people with Type 2 Diabetes, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- DA5221-T1, DA5221-T2 and DA5221-B1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2024to 31 Mar 2026
- 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
- Patients with type II diabetes mellitus aged 19 years or older
- Patients who had taken DA5221-B1 and DA5221-B2(or another DPP-4 inhibitor is allowed) combination therapy at the same dose for at least 8 weeks prior to the screening visit
- Patients with fasting plasma glucose≤270mg/dL at the screening visit
- Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
- Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study
Who cannot join
- Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
- Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure
- Patients with severe infectious disease or severe traumatic systemic disorders
- Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
- Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University college of Medicine
Seoul
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple combination therapy.
- Conditions
- Type 2 Diabetes
- Being tested
- DA5221-T1, DA5221-T2, Placebo, DA5221-B1, DA5221-B2
- 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.
DA5221-T1Drug
DA5221-T1 + DA5221-R2, orally, once daily, up to 24 weeks
DA5221-T2Drug
DA5221-R1 + DA5221-T2, orally, once daily, up to 24 weeks
PlaceboDrug
DA5221-R1 + DA5221-R2, orally, once daily, up to 24 weeks
DA5221-B1Drug
DA5221-B1, orally, daily for background therapy
DA5221-B2Drug
DA5221-B2, orally, daily for background therapy
| Study group | Role | What they receive |
|---|---|---|
| DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2 | Experimental | Not described Receives: Drug: DA5221-T1; Drug: DA5221-B1; Drug: DA5221-B2 |
| DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2 | Experimental | Not described Receives: Drug: DA5221-T2; Drug: DA5221-B1; Drug: DA5221-B2 |
| DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2 | Placebo comparator | Not described Receives: Drug: Placebo; Drug: DA5221-B1; Drug: DA5221-B2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline in HbA1c (%) after 24 weeks
Measured: Baseline, 24 weeks
Secondary outcomes (3)
Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks
Measured: Baseline, 24 weeks
Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks
Measured: Baseline, 24 weeks
Change from the baseline in weight after 24 weeks
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Apr 2024
- Primary completion5 Sep 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 174 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
- NCT06290349
- Sponsor's protocol ID
- DA5221_DM_III
- Status last verified
- Nov 2025
- First submitted
- 26 Feb 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT06290349
- Acronym / sponsor ID
- DA5221_DM_III
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 4 Mar 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 evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple 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 |
|---|---|---|
| DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2 | Experimental | Drug: DA5221-T1, Drug: DA5221-B1, Drug: DA5221-B2 |
| DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2 | Experimental | Drug: DA5221-T2, Drug: DA5221-B1, Drug: DA5221-B2 |
| DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2 | Placebo comparator | Drug: Placebo, Drug: DA5221-B1, Drug: DA5221-B2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with type II diabetes mellitus aged 19 years or older
- Patients who had taken DA5221-B1 and DA5221-B2(or another DPP-4 inhibitor is allowed) combination therapy at the same dose for at least 8 weeks prior to the screening visit
- Patients with fasting plasma glucose≤270mg/dL at the screening visit
- Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
- Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study
Key exclusion criteria (5 listed)
- Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
- Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure
- Patients with severe infectious disease or severe traumatic systemic disorders
- Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
- Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption
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 |
|---|---|---|
| DA5221-T1DA5221-T1 + DA5221-R2, orally, once daily, up to 24 weeks | Drug | DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2 |
| DA5221-T2DA5221-R1 + DA5221-T2, orally, once daily, up to 24 weeks | Drug | DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2 |
| PlaceboDA5221-R1 + DA5221-R2, orally, once daily, up to 24 weeks | Drug | DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2 |
| DA5221-B1DA5221-B1, orally, daily for background therapy | Drug | DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2, DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2, DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2 |
| DA5221-B2DA5221-B2, orally, daily for background therapy | Drug | DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2, DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2, DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2 |
Primary outcome
Change from the baseline in HbA1c (%) after 24 weeks
Time frame: Baseline, 24 weeks
3 secondary outcomes
Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks
Time frame: Baseline, 24 weeks
Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks
Time frame: Baseline, 24 weeks
Change from the baseline in weight after 24 weeks
Time frame: Baseline, 24 weeks
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 19 Nov 2025.
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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 DA5221-T1, DA5221-T2 and DA5221-B1 in people with Type 2 Diabetes, 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 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?
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?
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 from the baseline in HbA1c (%) after 24 weeks (time frame: Baseline, 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 19 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.