Study to Evaluate the Long Term Safety and Efficacy of DWP16001 Compared to Placebo in the Treatment of T2DM.
A Multi-center, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2021
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2021
CompletedFirst Submitted
Initial submission to the registry
January 9, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedOctober 25, 2022
January 1, 2022
9 months
January 9, 2022
October 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
\*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria
at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Secondary Outcomes (3)
Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Study Arms (1)
DWP16001
EXPERIMENTALDWP16001 Tablets
Interventions
Eligibility Criteria
You may qualify if:
- Voluntarily decided to participate in the extension study and provided a written consent on the consent form
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daewoong pharmatceutical
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2022
First Posted
May 17, 2022
Study Start
September 16, 2021
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
October 25, 2022
Record last verified: 2022-01