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NCT05814406 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05814406
Other study ID # JW22302
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 12, 2023
Est. completion date December 15, 2025

Study information
Verified date May 2023
Source JW Pharmaceutical
Contact Daegeun Song
Phone +82-2-840-6792
Email 20190122@jw-group.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date December 15, 2025
Est. primary completion date June 15, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Type 2 Diabetes Mellitus Exclusion Criteria: - Type 1 Diabetes Mellitus - The subject not meet the specified HbA1c and FPG

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Chosun University Hospital Gwangju

Sponsors (1)
Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1C (24 Weeks) lowering effect change in HbA1c 24 Weeks
Secondary HbA1c lowering effect change in HbA1c 6, 12, 18 Weeks
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