Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes
NCT03627182 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2018-08-13
Summary
The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.
Conditions
- Type2 Diabetes
Interventions
- DRUG
-
CKD-501 0.5mg
CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745
- DRUG
-
Placebo, orally, 1 tablet once a day for 24weeks with D150 and D745. CKD-501 placebo will be changed to CKD-501 from extension stydy to EOS(end of study).
Sponsors & Collaborators
-
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Principal Investigators
-
BongSoo Cha, Ph.D · Severance Hospital, Yonsei University Health System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-26
- Primary Completion
- 2022-03-29
- Completion
- 2023-02-10
Countries
- South Korea
Study Locations
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