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

Phase 3

Recruiting

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: JW0201

• Registration Number: NCT05814406
• Lead Sponsor: JW Pharmaceutical

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

Study Timeline

• Study Start: 2023-01-12
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-06-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Type 2 Diabetes Mellitus

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C2202+C2204	Placebo	Placebo group, Treatment period for 24 weeks
JW0201+C2202+C2204	JW0201	Experimental group, Treatment period for 24 weeks

Primary Outcome Measures

Name	Time	Method
HbA1C (24 Weeks) lowering effect	24 Weeks	change in HbA1c

Secondary Outcome Measures

Name	Time	Method
HbA1c lowering effect	6, 12, 18 Weeks	change in HbA1c

Trial Locations

Locations (1)

Chosun University Hospital; 🇰🇷 Gwangju, Korea, Republic of