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

YooYoung Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: YYC405-T placebo; Drug: Dapagliflozin 10mg; Drug: YYC405-T; Drug: Metformin≥1000mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05226897

YYPCT_YYC405_301

Details and patient eligibility

About

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

Full 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

Enrollment: 256 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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256 participants in 2 patient groups, including a placebo group

Test

Experimental group

Description:

Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg

Treatment:

Drug: YYC405-T

Drug: Dapagliflozin 10mg

Drug: Metformin≥1000mg

Placebo control

Placebo Comparator group

Description:

Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg

Treatment:

Drug: YYC405-T placebo

Drug: Dapagliflozin 10mg

Drug: Metformin≥1000mg