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

Phase 3

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: DA5221-T1; Drug: Placebo; Drug: DA5221-T2; Drug: DA5221-B1; Drug: DA5221-B2

• Registration Number: NCT06290349
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study Start: 2024-02-28
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Primary Completion: 2025-05-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2	DA5221-T1	-
DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2	Placebo	-
DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2	DA5221-T2	-
DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2	DA5221-B1	-
DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2	DA5221-B2	-
DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2	DA5221-B1	-
DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2	DA5221-B2	-
DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2	DA5221-B2	-
DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2	DA5221-B1	-

Primary Outcome Measures

Name	Time	Method
Change from the baseline in HbA1c (%) after 24 weeks	Baseline, 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change from the baseline in weight after 24 weeks	Baseline, 24 weeks
Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks	Baseline, 24 weeks
Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks	Baseline, 24 weeks

Trial Locations

Locations (1)

Severance Hospital, Yonsei University college of Medicine; 🇰🇷 Seoul, Korea, Republic of