Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT05376969
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* Withdrawn from the prior phase 3 study (Protocol No: DW\_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT05376969
Study Brief:
Protocol Section:
NCT05376969