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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290349
• Other study ID #: DA5221_DM_III
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 28, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: February 2024
• Source: Dong-A ST Co., Ltd.
• Contact: Sung
• Phone: +82-920-8369
• Email: jhsung[@]donga.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: November 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• DA5221-T1
DA5221-T1 + DA5221-R2, orally, once daily, up to 24 weeks
• DA5221-T2
DA5221-R1 + DA5221-T2, orally, once daily, up to 24 weeks
• Placebo
DA5221-R1 + DA5221-R2, orally, once daily, up to 24 weeks
• DA5221-B1
DA5221-B1, orally, daily for background therapy
• DA5221-B2
DA5221-B2, orally, daily for background therapy

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University college of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the baseline in HbA1c (%) after 24 weeks		Baseline, 24 weeks
Secondary	Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks		Baseline, 24 weeks
Secondary	Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks		Baseline, 24 weeks
Secondary	Change from the baseline in weight after 24 weeks		Baseline, 24 weeks