| Trial ID: | L6968 |
| Source ID: | NCT05814393
|
| Associated Drug: |
Treatment Period(Jw0201)
|
| Title: |
To Evaluate the Efficacy and Safety of JW0201 Added on in Patients with Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Treatment Period(JW0201)|DRUG: Treatment Period(Placebo)|DRUG: Extension Period(JW0201)
|
| Outcome Measures: |
Primary: HbA1c (24 Weeks) lowering effect, change in HbA1c, 24 Weeks | Secondary: HbA1c lowering effect, change in HbA1c, 6, 12, 18, 32, 40, 52 Weeks
|
| Sponsor/Collaborators: |
Sponsor: JW Pharmaceutical
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-01-03
|
| Completion Date: |
2025-08
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-07
|
| Locations: |
Kangbuk Samsung Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT05814393
|
