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

Phase 3

• Conditions: Type 2 Diabetes
• Interventions: Drug: YYC405-T; Drug: Metformin≥1000mg; Drug: Dapagliflozin 10mg; Drug: YYC405-T placebo

• Registration Number: NCT05226897
• Lead Sponsor: Yooyoung Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2021-07-12
• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-07
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01
• Primary Completion: 2022-10-31
• Study Completion: 2023-06-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	YYC405-T	Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
Test	Metformin≥1000mg	Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
Test	Dapagliflozin 10mg	Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
Placebo control	Metformin≥1000mg	Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg
Placebo control	YYC405-T placebo	Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg
Placebo control	Dapagliflozin 10mg	Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg

Primary Outcome Measures

Name	Time	Method
HbA1c	Baseline, 24 weeks	Change from baseline in Glycosylated Hemoglobin (HbA1c)

Secondary Outcome Measures

Name	Time	Method
C-peptide	Baseline, 12weeks, 24weeks	Change from baseline in C-peptide
FPG, Fasting insulin	Baseline, 12weeks, 24weeks	Change from baseline in Fasing plasma glucose and Fasting insulin
HbA1c	Baseline, 12weeks	Change from baseline in Glycosylated Hemoglobin (HbA1c)

Trial Locations

Locations (1)

The Catholic University of Korea(Bucheon St. Mary's Hospital); 🇰🇷 Bucheon, Korea, Republic of