Status:
COMPLETED
Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
T2DM (Type 2 Diabetes Mellitus)
Eligibility:
All Genders
19-80 years
Phase:
PHASE3
Brief Summary
A Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately controlled on metformin
Eligibility Criteria
Inclusion
- Participated in the prior phase 3 study (Protocol No: DW\_DWP16001302) for meeting the inclusion criteria and completed the study
- Voluntarily decided to participate in the extension study and provided a written consent on the consent form
Exclusion
- Withdrawn from the prior phase 3 study (Protocol No: DW\_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator
- Subjects with the following diseases or signs:
- Diabetic ketoacidosis
- Moderate to severe renal impairment (estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73 m2
- Females who are pregnant or breast-feeding, or subjects who do not agree to the use of appropriate contraceptive methods throughout the study
- Subjects must agree to one of the following appropriate contraceptive methods for subjects or their partners:
- ① Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or
- ② A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or
- ③ Use of male condom combined with either cervical cap or diaphragm Determined to be ineligible for the study by the investigator, besides the above
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2022
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT05376969
Start Date
May 25 2021
End Date
May 16 2022
Last Update
October 25 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Daewoong pharmatceutical
Seoul, South Korea