NCT05226897

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Yooyoung Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	YYC405-T	Subjects take the investigational products once a day for 24 weeks.
DRUG	Metformin≥1000mg	Subjects take the investigational products once a day for 24 weeks.
DRUG	Dapagliflozin 10mg	Subjects take the investigational products once a day for 24 weeks.
DRUG	YYC405-T placebo	Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks.

Timeline

• Start date: 2021-07-12
• Primary completion: 2022-10-31
• Completion: 2023-06-26
• First posted: 2022-02-07
• Last updated: 2022-06-01

Locations

1 site across 1 country: South Korea