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

September 2, 2025 updated by: JW Pharmaceutical

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Gwangju, South Korea, 61452
        • Chosun University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 Diabetes Mellitus

Exclusion Criteria:

  • Type 1 Diabetes Mellitus
  • The subject not meet the specified HbA1c and FPG

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JW0201+C2202+C2204
Experimental group, Treatment period for 24 weeks
Drug: JW0201
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)
Other Names:
  • JW0201+C2022+C2204
Placebo Comparator: C2202+C2204
Placebo group, Treatment period for 24 weeks
Drug: Placebo
C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2204: 10 mg/day for 24 Weeks(PO, BID)
Other Names:
  • C2022+C2204

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1C (24 Weeks) lowering effect
Time Frame: 24 Weeks
change in HbA1c
24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c lowering effect
Time Frame: 6, 12, 18 Weeks
change in HbA1c
6, 12, 18 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Sangyong Kim, Chosun University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Actual)

March 21, 2024

Study Completion (Actual)

March 21, 2024

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JW22302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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