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To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With T2DM

Sponsor
JW Pharmaceutical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05814406
Collaborator
(none)
180
Enrollment
1
Location
2
Arms
35.1
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

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 C2204

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 C2204
Actual Study Start Date :
Jan 12, 2023
Anticipated Primary Completion Date :
Jun 15, 2025
Anticipated Study Completion Date :
Dec 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: JW0201+C2202+C2204

Treatment

Drug: JW0201
For 24 weeks(PO, BID)
Other Names:
  • JW0201+C2022+C2204

    		•
    Placebo Comparator: C2202+C2204

    Placebo

    Drug: Placebo
    For 24 weeks(PO, BID)
    Other Names:
  • C2022+C2204

    		•

    Outcome Measures

    Primary Outcome Measures

    1. HbA1C (24 Weeks) lowering effect [24 Weeks]

      change in HbA1c

    Secondary Outcome Measures

    1. efficacy and safety [24 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 Chosun University Hospital Gwangju Korea, Republic of 61452

    Sponsors and Collaborators

    • JW Pharmaceutical

    Investigators

    • Principal Investigator: Sangyong Kim, Chosun University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JW Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT05814406
    Other Study ID Numbers:
    • JW22302
    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
    Keywords provided by JW Pharmaceutical
    Diabetes Mellitus
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Apr 14, 2023