New triple therapy aims to tame type 2 diabetes
NCT ID NCT06290349
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a third drug (DA5221-T) to an existing two-drug combination can improve blood sugar control in adults with type 2 diabetes. About 174 participants who are not meeting their blood sugar goals will receive either the extra drug or a placebo for 24 weeks. The main goal is to see if the triple therapy lowers HbA1c (a key blood sugar measure) more effectively than the two-drug regimen alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
174 people
The number who actually took part.
- Started
-
Apr 2024
- Expected to finish
-
Mar 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with type II diabetes mellitus aged 19 years or older 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: 1. Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Severance Hospital, Yonsei University college of Medicine
Seoul, South Korea
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