Age
Item
male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
previously diagnosed as having type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≥7.0% and ≤10.5%
boolean
C0474680 (UMLS CUI [1])
Body Weight
Item
body weight ≥ 30 kg
boolean
C0005910 (UMLS CUI [1])
Metformin Dose Stable
Item
stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Gender Serum pregnancy test negative | Gender Urine pregnancy test negative
Item
women must have a negative serum or urine pregnancy test
boolean
C0079399 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Gender Breast Feeding Absent
Item
women must not be breastfeeding
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Antidiabetics | Exception Metformin
Item
current use of anti-diabetic medications or use within the specified timeframe prior to screening (exception: metformin)
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose (fpg) > 255 mg/dl
boolean
C0583513 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
diabetic ketoacidosis (dka) within 6 months of study entry
boolean
C0011880 (UMLS CUI [1])
Abnormal renal function
Item
abnormal renal function
boolean
C0151746 (UMLS CUI [1])
Liver disease
Item
active liver disease
boolean
C0023895 (UMLS CUI [1])
Anemia
Item
anemia
boolean
C0002871 (UMLS CUI [1])
Serum thyroid stimulating hormone abnormal
Item
an abnormal thyroid stimulating hormone (tsh)
boolean
C0857987 (UMLS CUI [1])
Elevated creatinine kinase
Item
creatinine kinase (ck) ≥ 3x uln
boolean
C1657311 (UMLS CUI [1])