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 @ 12:55 PM
Ignite Modification Date:
2025-12-24 @ 12:55 PM
NCT ID:
NCT03910361
Eligibility Criteria:
Inclusion Criteria:
* Type II diabetes mellitus
* Subjects who have not been taking any oral hypoglycemic agent within 8 weeks from screening or who have been taking metformin monotherapy at the same dose for more than 8 weeks before screening
* Subjects with 6.5%≤HbA1c≤9.0% at screening
* Subjects with 20kg/m2≤BMI≤40kg/m2 at screening
Exclusion Criteria:
* Type I diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* AST \> upper normal range\*3
* Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Subjects who experienced hypersensitivity reaction against DPP-4 inhibitors, thiazolidinediones
* Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT03910361
Study Brief:
Protocol Section:
NCT03910361