| Trial ID: | L6770 |
| Source ID: | NCT04170998
|
| Associated Drug: |
Evogliptin 5mg
|
| Title: |
Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2 Diabetes
|
| Interventions: |
DRUG: Evogliptin 5mg|DRUG: Evogliptin Placebo|DRUG: Dapagliflozin 10mg|DRUG: Metformin ≥ 1000mg
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c (%) After 24 weeks, 24 weeks | Secondary: Change from baseline in FPG(mg/dL) After 24 weeks, 24 weeks|Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks, 24 weeks|Change from baseline in 7-point SMBG After 24 weeks, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Dong-A ST Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
283
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-01-02
|
| Completion Date: |
2021-12-08
|
| Results First Posted: |
|
| Last Update Posted: |
2021-12-10
|
| Locations: |
Seoul St, Mary's Hospital,The Catholic University of Korea, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT04170998
|
