To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus

Last updated: September 2, 2025
Sponsor: JW Pharmaceutical
Overall Status: Completed

Phase

3

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Hypertriglyceridemia

Treatment

Treatment Period(Placebo)

Treatment Period(JW0201)

Extension Period(JW0201)

Clinical Study ID

NCT05814393
JW22301
  • Ages > 19
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Type 2 Diabetes Mellitus

Exclusion

Exclusion Criteria:

  • Type 1 Diabetes Mellitus

  • The subject not meet the specified HbA1c and FPG

Study Design

Total Participants: 200
Treatment Group(s): 3
Primary Treatment: Treatment Period(Placebo)
Phase: 3
Study Start date:
January 03, 2023
Estimated Completion Date:
November 20, 2024

Study Description

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

Connect with a study center

  • Kangbuk Samsung Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul 1835848,
    South Korea

    Site Not Available

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