The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of D150, D745 and D759 Combination Therapy in Pateints With Type 2 Diabetes Inadequately Controlled With D150 Plus D759

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566028
• Other study ID #: A127_02DM2210
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2022
• Est. completion date: October 29, 2024

Study information

• Verified date: September 2022
• Source: Chong Kun Dang Pharmaceutical
• Contact: Youngmin Cho, M.D, Ph.D
• Phone: +8202-2072-1965
• Email: ymchomd[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to prove that the group treated with D745 in combination added that the reduction of HbA1c superior to placebo treated group added in combination.

Description:

The aim of this phase 3 study is to evaluate the efficacy and safety of additional combined D745 administration for 24 weeks in patient with type 2 diabetes who are no adequately controlled for blood glucose by the combination of D150 and D759

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: October 29, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

Inclusion Criteria:

• between 19 years and 85 years old(male or female)
• Type 2 diabetes mellitus
• BMI between 18.5kg/m2 and 40kg/m2
• Agreement with written informed consent

Exclusion Criteria:

• Type 1 diabetes mellitus or secondary diabetes mellitus
• Patients with complications of severe diabetes such as proliferative diabetic retinopathy
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Patients with abnormal laboratory test results according to the protocol
• Continuous or non continuous treatment insulin within 12 weeks prior to screening
• Chronic oral or non oral corticosteroids treatment within 4 weeks prior to screening

Related Conditions & MeSH terms

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

Intervention

Drug:
• D745 formulation I
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
• D745 formulation II
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
• D745 Placebo
QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		Baseline, 24 week
Secondary	Change from baseline in HbA1c		Baseline, 12 week
Secondary	Change from baseline in Fasting plasma glucose		Baseline, 12 week, 24 week