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
NCT ID: NCT06290349
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
174 participants
INTERVENTIONAL
2024-04-01
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing BT-1 and BT-2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
NCT07239440
Clinical Trial to Evaluate the Efficacy and Safety of DA-5218 in Patients With Type 2 Diabetes
NCT07229534
A Study To Evaluate The Safety,Tolerability, PK and PD Of DA-1241 In Healthy Male Subjects
NCT03061981
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
NCT05743907
A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM
NCT03646721
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2
DA5221-T1
DA5221-T1 + DA5221-R2, orally, once daily, up to 24 weeks
DA5221-B1
DA5221-B1, orally, daily for background therapy
DA5221-B2
DA5221-B2, orally, daily for background therapy
DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2
DA5221-T2
DA5221-R1 + DA5221-T2, orally, once daily, up to 24 weeks
DA5221-B1
DA5221-B1, orally, daily for background therapy
DA5221-B2
DA5221-B2, orally, daily for background therapy
DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2
Placebo
DA5221-R1 + DA5221-R2, orally, once daily, up to 24 weeks
DA5221-B1
DA5221-B1, orally, daily for background therapy
DA5221-B2
DA5221-B2, orally, daily for background therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DA5221-T1
DA5221-T1 + DA5221-R2, orally, once daily, up to 24 weeks
DA5221-T2
DA5221-R1 + DA5221-T2, orally, once daily, up to 24 weeks
Placebo
DA5221-R1 + DA5221-R2, orally, once daily, up to 24 weeks
DA5221-B1
DA5221-B1, orally, daily for background therapy
DA5221-B2
DA5221-B2, orally, daily for background therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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
3. Patients with fasting plasma glucose≤270mg/dL at the screening visit
4. Patients with 18.5kg/m\^2≤BMI≤40kg/m\^2 at the screening visit
5. Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study
Exclusion Criteria
2. 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
3. Patients with severe infectious disease or severe traumatic systemic disorders
4. Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
5. Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Severance Hospital, Yonsei University college of Medicine
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DA5221_DM_III
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.