Age | Informed Consent
Item
aged from 20 to 80 years inclusive on the day of informed consent;
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period;
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
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;
boolean
C0474680 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Disease | Secondary diabetes mellitus | Acromegaly | Cushing Syndrome
Item
type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, cushing's syndrome, etc.);
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0030286 (UMLS CUI [2,3])
C0271640 (UMLS CUI [3])
C0001206 (UMLS CUI [4])
C0010481 (UMLS CUI [5])
Complications of Diabetes Mellitus Severe | Proliferative diabetic retinopathy | Kidney Disease TNM clinical staging | Diabetic Ketoacidosis | Diabetic Neuropathy Serious
Item
past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage iii or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
boolean
C0342257 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0154830 (UMLS CUI [2])
C0022658 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0011880 (UMLS CUI [4])
C0011882 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
Fasting blood glucose measurement
Item
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;
boolean
C0428568 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
egfr of <60 ml/min/1.73 m2 on the start day of the run-in period;
boolean
C3811844 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg on the start or end day of the run-in period;
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Cerebrovascular Disorders
Item
history of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period;
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
Kidney Disease Serious | Liver disease Serious | Hospitalization Required | Surgical intervention Required
Item
concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease;
boolean
C0022658 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1708385 (UMLS CUI [3])
C0549433 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Relapse Free of
Item
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.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
Drug Allergy | Shock | Symptoms Anaphylactoid
Item
past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
boolean
C0013182 (UMLS CUI [1])
C0036974 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C1706805 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Childbearing Potential
Item
pregnant women, lactating mothers, or women of childbearing potential;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Condition Study Subject Participation Status Ineligible
Item
any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])