NCT06290349Active, not recruitingPhase 3
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 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
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 174 (actual)
- First submitted
- 26 Feb 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 5 Sept 2025
- Lead sponsor
- Dong-A ST Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT06290349
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 174
- From 1 Apr 2024 to the primary completion date, 5 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance Hospital, Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.