To Evaluate the Efficacy and Safety of JW0201 Added on in Patients with Type 2 Diabetes Mellitus
Phase 3
Active, not recruiting
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Treatment Period(JW0201)Drug: Treatment Period(Placebo)Drug: Extension Period(JW0201)
- Registration Number
- NCT05814393
- 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 C2203
- Detailed Description
A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
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 JW0201+C2202+C2203 Extension Period(JW0201) Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks) C2202+C2203 Extension Period(JW0201) Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks) JW0201+C2202+C2203 Treatment Period(JW0201) Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks) C2202+C2203 Treatment Period(Placebo) Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 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, 32, 40, 52 Weeks change in HbA1c
Trial Locations
- Locations (1)
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of