| Trial ID: | L2023 |
| Source ID: | NCT05505994
|
| Associated Drug: |
Dwp16001
|
| Title: |
The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Diabetes Mellitus, Type 2|Glucose Metabolism Disorders|Metabolic Disease|Endocrine System Diseases
|
| Interventions: |
DRUG: DWP16001|DRUG: Dapagliflozin|DRUG: DWP16001 Placebo|DRUG: Dapagliflozin Placebo
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c, Change in HbA1c (%) is assessed with the values measured at the central laboratory, at 24 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Daewoong Pharmaceutical Co. LTD.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
340
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-09-28
|
| Completion Date: |
2024-09
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-04
|
| Locations: |
Peking University People's Hospital, Beijing, Beijing, +86, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05505994
|
