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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT01022112
Eligibility Criteria:
Inclusion Criteria:
* Aged from 20 to 80 years inclusive on the day of informed consent;
* Patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period;
* Patients with HbA1c of ≥6.5% and ≤9.5% (according to the Japan Diabetic Society \[JDS\] criteria) on the start day of the run-in period;
Exclusion Criteria:
* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
* Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
* Fasting blood glucose of \>270 mg/dL on the start day of the run-in period or at Week 2 of the run-in period;
* eGFR of \<60 mL/min/1.73 m2 on the start day of the run-in period;
* Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
* History of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period;
* Concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease;
* Past or current history of malignant tumor; however, this criterion shall not apply to those who have been free of relapse for at least 5 years even with a history of malignant tumor.
* Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
* Pregnant women, lactating mothers, or women of childbearing potential;
* Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT01022112
Study Brief:
Protocol Section:
NCT01022112