Back to resultsClinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients
Primary Purpose
Type 2 Diabetes
Status
Active
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YYC405-T
Metformin≥1000mg
Dapagliflozin 10mg
YYC405-T placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- The Catholic University of Korea(Bucheon St. Mary's Hospital)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test
Placebo control
Arm Description
Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg
Outcomes
Primary Outcome Measures
HbA1c
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Secondary Outcome Measures
HbA1c
Change from baseline in Glycosylated Hemoglobin (HbA1c)
FPG, Fasting insulin
Change from baseline in Fasing plasma glucose and Fasting insulin
C-peptide
Change from baseline in C-peptide
Full Information
NCT ID
NCT05226897
First Posted
January 17, 2022
Last Updated
May 30, 2022
Sponsor
Yooyoung Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05226897
Brief Title
Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
June 26, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yooyoung Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
256 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg
Intervention Type
Drug
Intervention Name(s)
YYC405-T
Intervention Description
Subjects take the investigational products once a day for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Metformin≥1000mg
Intervention Description
Subjects take the investigational products once a day for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10mg
Intervention Description
Subjects take the investigational products once a day for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
YYC405-T placebo
Intervention Description
Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks.
Primary Outcome Measure Information:
Title
HbA1c
Description
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame
Baseline, 24 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Description
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame
Baseline, 12weeks
Title
FPG, Fasting insulin
Description
Change from baseline in Fasing plasma glucose and Fasting insulin
Time Frame
Baseline, 12weeks, 24weeks
Title
C-peptide
Description
Change from baseline in C-peptide
Time Frame
Baseline, 12weeks, 24weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sungrae Kim, MD, Ph.D
Organizational Affiliation
Bucheon St Mary Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The Catholic University of Korea(Bucheon St. Mary's Hospital)
City
Bucheon
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients
We'll reach out to this number within 24 hrs