NCT05814406

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	JW0201	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)
DRUG	Placebo	C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2204: 10 mg/day for 24 Weeks(PO, BID)

Timeline

• Start date: 2023-01-12
• Primary completion: 2024-03-21
• Completion: 2024-03-21
• First posted: 2023-04-14
• Last updated: 2025-09-09

Locations

1 site across 1 country: South Korea