Back to resultsTo Evaluate the Efficacy and Safety of JW0201 Added on in Patients With T2DM
Primary Purpose
Type 2 Diabetes Mellitus
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JW0201
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Type 2 Diabetes Mellitus Exclusion Criteria: Type 1 Diabetes Mellitus The subject not meet the specified HbA1c and FPG
Sites / Locations
- Chosun University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
JW0201+C2202+C2204
C2202+C2204
Arm Description
Experimental group, Treatment period for 24 weeks
Placebo group, Treatment period for 24 weeks
Outcomes
Primary Outcome Measures
HbA1C (24 Weeks) lowering effect
change in HbA1c
Secondary Outcome Measures
HbA1c lowering effect
change in HbA1c
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05814406
Brief Title
To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With T2DM
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With C2202 and C2204
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study to evaluate the efficacy and safety of JW0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with C2202 and C2204
Detailed Description
A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JW0201+C2202+C2204
Arm Type
Experimental
Arm Description
Experimental group, Treatment period for 24 weeks
Arm Title
C2202+C2204
Arm Type
Placebo Comparator
Arm Description
Placebo group, Treatment period for 24 weeks
Intervention Type
Drug
Intervention Name(s)
JW0201
Other Intervention Name(s)
JW0201+C2022+C2204
Intervention Description
JW0201: 200mg/day For 24 weeks(PO, BID) C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2204: 10 mg/day for 24 Weeks(PO, BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
C2022+C2204
Intervention Description
C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2204: 10 mg/day for 24 Weeks(PO, BID)
Primary Outcome Measure Information:
Title
HbA1C (24 Weeks) lowering effect
Description
change in HbA1c
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
HbA1c lowering effect
Description
change in HbA1c
Time Frame
6, 12, 18 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 Diabetes Mellitus
Exclusion Criteria:
Type 1 Diabetes Mellitus
The subject not meet the specified HbA1c and FPG
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daegeun Song
Phone
+82-2-840-6792
Email
20190122@jw-group.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Dongryeong Lee
Phone
+82-28406982
Email
dongryung.lee@jw-pharma.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangyong Kim
Organizational Affiliation
Chosun University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chosun University Hospital
City
Gwangju
ZIP/Postal Code
61452
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangyong Kim
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With T2DM
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