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CompletedNCT05814393Updated Sep 9, 2025

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

A Phase 3 interventional study of Treatment Period(JW0201) and Treatment Period(Placebo) in Type 2 Diabetes Mellitus, sponsored by JW Pharmaceutical. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by JW Pharmaceutical · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2023, registered Apr 2023).
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

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

Read the detailed description

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

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 200 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

JW Pharmaceutical is the lead sponsor of 75 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 Diabetes Mellitus

Exclusion criteria

Exclusion Criteria:

  • Type 1 Diabetes Mellitus
  • The subject not meet the specified HbA1c and FPG
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    JW0201+C2202+C2203

    Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)

    Drug: Treatment Period(JW0201) · Drug: Extension Period(JW0201)

  • Placebo comparator
    C2202+C2203

    Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)

    Drug: Treatment Period(Placebo) · Drug: Extension Period(JW0201)

Interventions

  • DrugTreatment 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)

    Also known as: JW0201+C2022+C2203

  • DrugTreatment Period(Placebo)

    C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID)

    Also known as: C2022+C2203

  • DrugExtension 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)

    Also known as: JW0201+C2022+C2203

06

What researchers measure

Primary outcomes

  1. HbA1c (24 Weeks) lowering effect

    change in HbA1c

    Time frame: 24 Weeks

Secondary outcomes

  1. HbA1c lowering effect

    change in HbA1c

    Time frame: 6, 12, 18, 32, 40, 52 Weeks

07

Study locations

1 site
  • Kangbuk Samsung Hospital
    Seoul, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05814393
Lead sponsor
JW Pharmaceutical
Responsible party
Sponsor
First posted
Apr 14, 2023
Start date
Jan 3, 2023
Primary completion
May 14, 2024
Completion
Nov 20, 2024
Last update
Sep 9, 2025

Study contacts

Cheol-Young Park
principal investigator · Kangbuk Samsung Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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