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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05814406

Enrollment

196

Registered

2023-04-14

Start date

2023-01-12

Completion date

2024-03-21

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus

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 C2204

Detailed description

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

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)

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 Diabetes Mellitus

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
HbA1C (24 Weeks) lowering effect	24 Weeks	change in HbA1c

Secondary

Measure	Time frame	Description
HbA1c lowering effect	6, 12, 18 Weeks	change in HbA1c

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026