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 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT02628392
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥ 20 years at the time of informed consent
* Japanese patients with type 2 diabetes
* Patients who have HbA1c ≥ 7.0% and \< 10.0%
Exclusion Criteria:
* Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis
* Patients receiving or requiring treatment with insulin
* Patients with a body mass index (BMI) of \< 18.5 kg/m2 or ≥ 35.0 kg/m2
* Patients with clinically evident renal impairment (estimated glomerular filtration rate \[eGFR\] of \< 45 mL/min per 1.73 m2) or clinically significant renal disease
* Patients with fasting plasma glucose ≥ 240 mg/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02628392
Study Brief:
Protocol Section:
NCT02628392