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NCT07239440Not yet recruitingPhase 2

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

A Multicenter, Double-blind, Active-controlled, Randomized, Parallel 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

Source: ClinicalTrials.gov · Last updated 20 Nov 2025

Brief summary (registry, in English)

This study is a multicenter, double-blind, active-controlled, randomized, parallel 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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
288 (estimated)
First submitted
16 Nov 2025
Start date
Nov 2025
Primary completion date
Dec 2026
Lead sponsor
Dong-A ST Co., Ltd.
NCT number
NCT07239440

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 288
  • From Nov 2025 to the primary completion date, Dec 2026
  • 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 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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.