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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05814393
Other study ID # JW22301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 3, 2023
Est. completion date August 2025

Study information

Verified date May 2023
Source JW Pharmaceutical
Contact Siyoung Heo
Phone +82-2-840-6811
Email 20190291@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 C2203


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date August 2025
Est. primary completion date June 2024
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


Intervention

Drug:
Treatment Period(JW0201)
JW0201: 200mg/day For 24 weeks(PO, BID) C2022: =1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID)
Treatment Period(Placebo)
C2022: =1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID)
Extension Period(JW0201)
JW0201: 200mg/day For 28 weeks(PO, BID) C2022: =1,000 mg/day for 28 Weeks(PO, BID) C2203: 25 mg/day for 28 Weeks(PO, BID)

Locations

Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul

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, 32, 40, 52 Weeks
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