NCT05814393

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2023

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

September 9, 2025

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

April 3, 2023

Last Update Submit

September 2, 2025

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c (24 Weeks) lowering effect

    change in HbA1c

    24 Weeks

Secondary Outcomes (1)

  • HbA1c lowering effect

    6, 12, 18, 32, 40, 52 Weeks

Study Arms (2)

JW0201+C2202+C2203

EXPERIMENTAL

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

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

C2202+C2203

PLACEBO COMPARATOR

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

Treatment Period(JW0201)DRUG

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
JW0201+C2202+C2203
Treatment Period(Placebo)DRUG

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

Also known as: C2022+C2203
C2202+C2203
Extension Period(JW0201)DRUG

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
C2202+C2203JW0201+C2202+C2203

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Cheol-Young Park

    Kangbuk Samsung Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 14, 2023

Study Start

January 3, 2023

Primary Completion

May 14, 2024

Study Completion

November 20, 2024

Last Updated

September 9, 2025

Record last verified: 2024-11

Locations

KR(1)