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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT02222350
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% if untreated with antidiabetic agent.
* Patients who have HbA1c ≥ 6.5% and \< 9.5% if treated with antidiabetic agent.
Exclusion Criteria:
* Patients aged ≥ 70 years at the time of informed consent
* Patients with a history of type 1 diabetes or diabetic 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 an estimated glomerular filtration rate (eGFR), \< 45 mL/min per 1.73 m2
* Patients with fasting plasma glucose ≥ 240 mg/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
69 Years
Study:
NCT02222350
Study Brief:
Protocol Section:
NCT02222350