| Trial ID: | L4116 |
| Source ID: | NCT05101135
|
| Associated Drug: |
Jt-001
|
| Title: |
To Evaluate the Efficacy and Safety of JT-001 add-on in Paatients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: JT-001|DRUG: JT-001 Placebo
|
| Outcome Measures: |
Primary: Changes in HbA1c, Changes in HbA1c at the 24th week from the baseline, 24th Week |
|
| Sponsor/Collaborators: |
Sponsor: Jeil Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
256
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-11-17
|
| Completion Date: |
2022-10-31
|
| Results First Posted: |
|
| Last Update Posted: |
2022-03-07
|
| Locations: |
Severance Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT05101135
|
