Diabetes Mellitus, Non-Insulin-Dependent
Item
patients must have a diagnosis of type 2 diabetes mellitus;
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hemoglobin a1c levels >=7.5% and <=10.5%;
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) 25 to 45 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Hypoglycemic Agents Patient untreated | Therapeutic procedure Hypoglycemic Agents Duration
Item
patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.
boolean
C0020616 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0020616 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Diseases | 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 Staging of disease | Diabetic Ketoacidosis | Diabetic Neuropathies 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])
C0449385 (UMLS CUI [3,2])
C0011880 (UMLS CUI [4])
C0011882 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
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 6 months before the start of the run-in period;
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
Malignant Neoplasms
Item
past or current history of malignant tumor;
boolean
C0006826 (UMLS CUI [1])
Drug Allergy | anaphylaxis | Drug-induced anaphylactoid reaction
Item
past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
boolean
C0013182 (UMLS CUI [1])
C0002792 (UMLS CUI [2])
C0344178 (UMLS CUI [3])
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 Limited
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])
C0439801 (UMLS CUI [1,3])