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
NCT04170998 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 283
Last updated 2021-12-10
Summary
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the 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
Conditions
- Type2 Diabetes
Interventions
- DRUG
-
Evogliptin 5mg
Participants receive Evogliptin 5mg orally once a day
- DRUG
-
Evogliptin Placebo
Participants receive placebo to match Evogliptin 5mg orally once a day
- DRUG
-
Dapagliflozin 10mg
Participants receive Dapagliflozin orally once a day
- DRUG
-
Metformin ≥ 1000mg
Metformin are administered at the same dose and formulation.
Sponsors & Collaborators
-
Dong-A ST Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-02
- Primary Completion
- 2021-06-28
- Completion
- 2021-12-08
Countries
- South Korea
Study Locations
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