Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

Type 2 Diabetes Clinical Trial

Official title:

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of YYC405-T Added to Metformin and Dapagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With the Combination of Metformin and Dapagliflozin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05226897
• Other study ID #: YYPCT_YYC405_301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 12, 2021
• Est. completion date: June 26, 2023

Study information

• Verified date: May 2022
• Source: Yooyoung Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 3 study to assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

Description:

Phase 3 study to assess the Efficacy and Safety of YYC405-T when added to Metformin and Dapagliflozin combination therapy in patients with type 2 diabetes mellitus who have inadequate glycemic control

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: June 26, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patient who contsent to participate in this tiral by written informed consent form

• A man or woman over 20 years old

• Type 2 Diabetes patients

Exclusion Criteria:

• Patients with severe renal impairment, end-stage renal disease or on dialysis

• Type 1 diabetes patients

• Patients with a history of acute or chronic target acidosis, including lactic acidosis and diabetic ketoacidosis

Related Conditions & MeSH terms

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

Intervention

Drug:
• YYC405-T
Subjects take the investigational products once a day for 24 weeks.
• Metformin=1000mg
Subjects take the investigational products once a day for 24 weeks.
• Dapagliflozin 10mg
Subjects take the investigational products once a day for 24 weeks.
• YYC405-T placebo
Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks.

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea(Bucheon St. Mary's Hospital)	Bucheon

Sponsors (1)

Lead Sponsor	Collaborator
Yooyoung Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change from baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, 24 weeks
Secondary	HbA1c	Change from baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, 12weeks
Secondary	FPG, Fasting insulin	Change from baseline in Fasing plasma glucose and Fasting insulin	Baseline, 12weeks, 24weeks
Secondary	C-peptide	Change from baseline in C-peptide	Baseline, 12weeks, 24weeks