CClinicalTrials.gg
CompletedNCT05814406Updated Sep 9, 2025

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

A Phase 3 interventional study of JW0201 and 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

Phase
Phase 3
Study type
Interventional
Enrollment
196
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 C2204

Read the detailed description

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

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • 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 196 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
196 participants (actual)

Study arms

  • Experimental
    JW0201+C2202+C2204

    Experimental group, Treatment period for 24 weeks

    Drug: JW0201

  • Placebo comparator
    C2202+C2204

    Placebo group, Treatment period for 24 weeks

    Drug: Placebo

Interventions

  • DrugJW0201

    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)

    Also known as: JW0201+C2022+C2204

  • DrugPlacebo

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

    Also known as: C2022+C2204

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 Weeks

07

Study locations

1 site
  • Chosun University Hospital
    Gwangju, 61452, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 ↗
10

Registry details

Key details

Study ID
NCT05814406
Lead sponsor
JW Pharmaceutical
Responsible party
Sponsor
First posted
Apr 14, 2023
Start date
Jan 12, 2023
Primary completion
Mar 21, 2024
Completion
Mar 21, 2024
Last update
Sep 9, 2025

Study contacts

Sangyong Kim
principal investigator · Chosun University 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 Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion