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

Dong-A ST

Status and phase: Active, not recruiting; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: DA5221-B1; Drug: DA5221-T2; Drug: DA5221-T1; Drug: Placebo; Drug: DA5221-B2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06290349

DA5221_DM_III

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 3 patient groups, including a placebo group

DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2

Experimental group

Treatment:

Drug: DA5221-B2

Drug: DA5221-T1

Drug: DA5221-B1

DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2

Experimental group

Treatment:

Drug: DA5221-B2

Drug: DA5221-B1

Drug: DA5221-T2

DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2

Placebo Comparator group

Treatment:

Drug: DA5221-B2

Drug: Placebo

Drug: DA5221-B1