Ireland
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Starting soon Phase 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

NCT07239440 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2025-11
Last updated
2025-11-20

Condition(s) studied

Diabete Mellitus

Investigational drug(s) / intervention(s)

DA-2811DA-2811-C

DA-2811: DA-2811 + DA-2811-R2, orally, once daily

DA-2811-C: DA-2811-C + DA-2811-R1, orally, once daily

Study summary

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

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients with type II diabetes mellitus aged 19 years or older 2. Patients with fasting plasma glucose≤270mg/dL at the screening visit 3. Patients with 18.5kg/m\^2≤BMI≤40kg/m\^2 at the screening visit 4. 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

Primary outcome measure(s)

  • HbA1c — Change from baseline at 12 weeks

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07239440 on ClinicalTrials.gov ↗ ← All trials in South Korea