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

NCT ID: NCT05814406

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2024-03-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

JW0201+C2202+C2204

Experimental group, Treatment period for 24 weeks

Group Type EXPERIMENTAL

JW0201

Intervention Type DRUG

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)

C2202+C2204

Placebo group, Treatment period for 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2204: 10 mg/day for 24 Weeks(PO, BID)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DRUG

Placebo

C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2204: 10 mg/day for 24 Weeks(PO, BID)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

JW0201+C2022+C2204 C2022+C2204

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 2 Diabetes Mellitus

Exclusion Criteria

* Type 1 Diabetes Mellitus
* The subject not meet the specified HbA1c and FPG
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sangyong Kim

Role: PRINCIPAL_INVESTIGATOR

Chosun University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chosun University Hospital

Gwangju, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JW22302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of ZT002 in Healthy Participants
NCT05491421 COMPLETED PHASE1