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

Sponsor
Yooyoung Pharmaceutical Co., Ltd.
Study ID
NCT05226897
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jul 12, 2021
Status verified
May 2022
Primary completion
Oct 31, 2022
Completion
Jun 26, 2023

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Test
    Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
  • Placebo Comparator: Placebo control
    Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg

Primary Outcome Measure

HbA1c [ Time Frame: Baseline, 24 weeks ]

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