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
NCT04356742 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198
Last updated 2022-03-22
Summary
This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.
Conditions
Interventions
- DRUG
-
Dapagliflozin 10mg
Dapagliflozin 10mg, orally, once daily, up to 24weeks
- DRUG
-
Dapagliflozin Placebo, orally, once daily, up to 24weeks
- DRUG
-
Evogliptin 5mg
Evogliptin 5mg, orally, once daily for background therapy
- DRUG
-
Metformin≥1000mg
Metformin≥1000mg, orally, daily for background therapy
Sponsors & Collaborators
-
Dong-A ST Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-26
- Primary Completion
- 2022-02-23
- Completion
- 2022-02-23
Countries
- South Korea
Study Locations
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