Trials / Completed
CompletedNCT05814393
To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (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 C2203
Detailed description
A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treatment Period(JW0201) | 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) |
| DRUG | Treatment Period(Placebo) | C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID) |
| DRUG | Extension Period(JW0201) | 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) |
Timeline
- Start date
- 2023-01-03
- Primary completion
- 2024-05-14
- Completion
- 2024-11-20
- First posted
- 2023-04-14
- Last updated
- 2025-09-09
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05814393. Inclusion in this directory is not an endorsement.