| Trial ID: | L5275 |
| Source ID: | NCT04356742
|
| Associated Drug: |
Dapagliflozin 10mg
|
| Title: |
Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Dapagliflozin 10mg|DRUG: Placebo|DRUG: Evogliptin 5mg|DRUG: Metforminâ„1000mg
|
| 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: |
198
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-05-26
|
| Completion Date: |
2022-02-23
|
| Results First Posted: |
|
| Last Update Posted: |
2022-03-22
|
| Locations: |
The Catholic University of Korea Bucheon St. Mary's Hospital, Bucheon, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT04356742
|
