| Trial ID: | L2538 |
| Source ID: | NCT04885712
|
| Associated Drug: |
Metforminâ„1000mg
|
| Title: |
A Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2 Diabetes
|
| Interventions: |
DRUG: Metforminâ„1000mg|DRUG: Pioglitazone 15mg|DRUG: Pioglitazone 30 mg|DRUG: Pioglitazone 15mg Placebo|DRUG: Pioglitazone 30mg Placebo|DRUG: Dapagliflozin 10mg
|
| Outcome Measures: |
Primary: Changes in HbA1c, Changes in HbA1c at the 24th week after the administration of investigational products from the baseline, 24th week |
|
| Sponsor/Collaborators: |
Sponsor: Boryung Pharmaceutical Co., Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
378
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-05-28
|
| Completion Date: |
2023-03-10
|
| Results First Posted: |
|
| Last Update Posted: |
2023-05-24
|
| Locations: |
Asan Medical Center, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT04885712
|
