To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus
Sponsor
JW Pharmaceutical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05814393
Collaborator
(none)
180
1
2
30.9
5.8
Study Details
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 C2203
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 C2203
Actual Study Start Date
:
Jan 3, 2023
Anticipated Primary Completion Date
:
Jun 1, 2024
Anticipated Study Completion Date
:
Aug 1, 2025
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: JW0201+C2202+C2203 Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks) |
Drug: Treatment Period(JW0201)
For 24 weeks(PO, BID)
Other Names:
Drug: Extension Period(JW0201)
For 28 weeks(PO, BID)
Other Names:
|
Placebo Comparator: C2202+C2203 Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks) |
Drug: Treatment Period(Placebo)
For 24 weeks(PO, BID)
Other Names:
Drug: Extension Period(JW0201)
For 28 weeks(PO, BID)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- HbA1c (24 Weeks) lowering effect [24 Weeks]
change in HbA1c
Secondary Outcome Measures
- HbA1c lowering effect [6, 12, 18, 32, 40, 52 Weeks]
change in HbA1c
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Type 2 Diabetes Mellitus
Exclusion Criteria:
-
Type 1 Diabetes Mellitus
-
The subject not meet the specified HbA1c and FPG
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Kangbuk Samsung Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- JW Pharmaceutical
Investigators
- Principal Investigator: Cheol-Young Park, Kangbuk Samsung Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT05814393
Other Study ID Numbers:
- JW22301
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: