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
1 other identifier
interventional
256
1 country
1
Brief Summary
Phase 3 study to assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Jul 2021
Typical duration for phase_3 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2021
CompletedFirst Submitted
Initial submission to the registry
January 17, 2022
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2023
CompletedJune 1, 2022
May 1, 2022
1.3 years
January 17, 2022
May 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Baseline, 24 weeks
Secondary Outcomes (3)
HbA1c
Baseline, 12weeks
FPG, Fasting insulin
Baseline, 12weeks, 24weeks
C-peptide
Baseline, 12weeks, 24weeks
Study Arms (2)
Test
EXPERIMENTALTake YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
Placebo control
PLACEBO COMPARATORTake YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg
Interventions
Subjects take the investigational products once a day for 24 weeks.
Subjects take the investigational products once a day for 24 weeks.
Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic University of Korea(Bucheon St. Mary's Hospital)
Bucheon-si, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sungrae Kim, MD, Ph.D
Bucheon St Mary Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2022
First Posted
February 7, 2022
Study Start
July 12, 2021
Primary Completion
October 31, 2022
Study Completion
June 26, 2023
Last Updated
June 1, 2022
Record last verified: 2022-05