Status:
COMPLETED
Study to Evaluate the Long Term Safety and Efficacy of DWP16001 Compared to Placebo in the Treatment of T2DM.
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
T2DM (Type 2 Diabetes Mellitus)
Eligibility:
All Genders
19-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is evaluate the long term safety and efficacy of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- Participated in the prior phase 3 study (Protocol No: DW\_DWP16001301) 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
- Those who dropped out of the previously conducted phase 3 clinical trial (Protocol No: DW\_DWP16001301)
- Pregnant or lactating women or those who do not consent to the use of appropriate contraceptive methods during clinical trials Appropriate method of birth control for you or your partner: You must agree to one of the following
- Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or
- A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or
- Use of male condom combined with either cervical cap or diaphragm
- In case the investigator judges that participation in this extended clinical trial is inappropriate in consideration of the 24-week observation progress in the previously conducted phase 3 clinical trial (Protocol No: DW\_DWP16001301)
Key Trial Info
Start Date :
September 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05376930
Start Date
September 16 2021
End Date
May 31 2022
Last Update
October 25 2022
Active Locations (1)
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1
Daewoong pharmatceutical
Seoul, South Korea