Gender | Female infertility | Age
Item
male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.
boolean
C0079399 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Body mass index | Body Weight
Item
body mass index of 18.0 to 45.4 kg/m2; and a total body weight of >50 kg
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Hemoglobin A1c measurement | Criteria Fulfill
Item
hba1c value at the screening visit meeting once of the following criteria:
boolean
C0474680 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Oral hypoglycemic | Hemoglobin A1c measurement
Item
currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5%
boolean
C0359086 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Oral hypoglycemic Absent | Hemoglobin A1c measurement
Item
not currently taking any oral antiglycemic drug therapy within 7 to 10.5%
boolean
C0359086 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
fasting plasma glucose concentrations<270mg/dl at the screening and run-in visit, confirmed by a single repeat, if deemed necessary.
boolean
C0583513 (UMLS CUI [1])
Blood Glucose Self-Monitoring times per day | Subject Diary Maintenance | Study Subject Literacy
Item
subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate.
boolean
C0005803 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C3890583 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
C0681850 (UMLS CUI [3,1])
C0023864 (UMLS CUI [3,2])
Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus
Item
history of type 1 diabetes mellitus or secondary forms of diabetes
boolean
C0011854 (UMLS CUI [1])
C0271640 (UMLS CUI [2])
Hypoglycaemic episode Severe Quantity | Timespan
Item
one or more self-reported hypoglycemic episodes of sever intensity within 3 months of screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within the previous 6 months.
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0872291 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Revascularization Arterial | Cerebrovascular accident | Heart failure New York Heart Association Classification | Transient Ischemic Attack
Item
history of myocardial infarction, unstable angina, arterial revascularization, stroke, new york heart association functional class ii-iv heart failure, or transient ischemic attach within 6 months of screening.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0581603 (UMLS CUI [3,1])
C0221464 (UMLS CUI [3,2])
C0038454 (UMLS CUI [4])
C0018801 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0007787 (UMLS CUI [6])
Complications of Diabetes Mellitus | End organ damage
Item
history or evidence of diabetic complications with significant end organ damage, such as
boolean
C0342257 (UMLS CUI [1])
C0743496 (UMLS CUI [2])
Proliferative retinopathy | Macular retinal edema
Item
proliferative retinopathy and/or macular edema;
boolean
C0339467 (UMLS CUI [1])
C0271051 (UMLS CUI [2])
Diabetic Neuropathy Complicated by Neuropathic ulcer
Item
diabetic neuropathy complicated by neuropathic ulcers;
boolean
C0011882 (UMLS CUI [1,1])
C0231242 (UMLS CUI [1,2])
C0333304 (UMLS CUI [1,3])
Sitting systolic blood pressure | Sitting diastolic blood pressure | Status post Rest Number of minutes
Item
screening seated systolic blood pressure >160 mm hg and/or diastolic blood pressure >100 mm hg after at least a 5 minute seated rest. if the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility;
boolean
C1319893 (UMLS CUI [1])
C1319894 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0035253 (UMLS CUI [3,2])
C1562039 (UMLS CUI [3,3])
Gender Partner Pregnancy | Male fertility Contraceptive methods Unwilling | Male fertility Contraceptive methods Unable
Item
male subjects with partners currently pregnant; or male subjects capable of conceiving children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C1955321 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1955321 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])