| Trial ID: | L5982 |
| Source ID: | NCT06290349
|
| Associated Drug: |
Da5221-T1
|
| Title: |
Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: DA5221-T1|DRUG: DA5221-T2|DRUG: Placebo|DRUG: DA5221-B1|DRUG: DA5221-B2
|
| Outcome Measures: |
Primary: Change from the baseline in HbA1c (%) after 24 weeks, Baseline, 24 weeks | Secondary: Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks, Baseline, 24 weeks|Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks, Baseline, 24 weeks|Change from the baseline in weight after 24 weeks, Baseline, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Dong-A ST Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
162
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-02-28
|
| Completion Date: |
2025-11-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-03-04
|
| Locations: |
Severance Hospital, Yonsei University college of Medicine, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT06290349
|
