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

Yooyoung Pharmaceutical Co., Ltd.256 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

256

Conditions

Type 2 Diabetes

Interventions

YYC405-TDRUG

Subjects take the investigational products once a day for 24 weeks.

Metformin≥1000mgDRUG

Subjects take the investigational products once a day for 24 weeks.

Dapagliflozin 10mgDRUG

Subjects take the investigational products once a day for 24 weeks.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

The Catholic University of Korea(Bucheon St. Mary's Hospital)

Bucheon-si, South Korea

Outcomes

Primary Outcomes

HbA1c

Change from baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: Baseline, 24 weeks

Secondary Outcomes

HbA1c

Change from baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: Baseline, 12weeks

FPG, Fasting insulin

Change from baseline in Fasing plasma glucose and Fasting insulin

Time frame: Baseline, 12weeks, 24weeks

C-peptide

Change from baseline in C-peptide

Time frame: Baseline, 12weeks, 24weeks

Data from ClinicalTrials.gov

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