| Trial ID: | L6031 |
| Source ID: | NCT05466643
|
| Associated Drug: |
Dwp16001 0.3mg
|
| Title: |
A Study to Investigate the Effect of DWP16001 as add-on Therapy to Drug A in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
ENHANCE-I
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: DWP16001 0.3mg|DRUG: DWP16001 Placebo
|
| Outcome Measures: |
Primary: Changes from Baseline HbA1c, at Week 24 |
|
| Sponsor/Collaborators: |
Sponsor: Daewoong Pharmaceutical Co. LTD.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
240
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-03-17
|
| Completion Date: |
2024-09-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-08
|
| Locations: |
Samsung Medical Center, Seoul, 135-710, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT05466643
|
