Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
The subjects, having voluntarily agreed to participate in the clinical trial and provided
informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting
the inclusion/exclusion criteria will go through an 8-week stabilization period.
At Visit 1-1, central laboratory tests will be conducted. If the test results meet the
criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the
clinical trial.
The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks.
They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and
efficacy assessments during the 52-week treatment period.