Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable
Item
patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Age
Item
male or female, 18-70 years of age
boolean
C0001779 (UMLS CUI [1])
Female Sterilization | Postmenopausal state | Gender | Age | Amenorrhea Duration | Serum FSH measurement | Contraceptive methods Quantity | Contraception, Barrier | Depot contraceptive Excluded
Item
all female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum fsh ≥ 40 miu/ml) or must agree to use two medically accepted methods of contraception including a barrier method. depo contraceptives are excluded.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0002453 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
C0455276 (UMLS CUI [6])
C0700589 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0004764 (UMLS CUI [8])
C0419530 (UMLS CUI [9,1])
C0332196 (UMLS CUI [9,2])
Gender | Pregnancy Absent | Breast Feeding Absent
Item
female patients must not be pregnant or lactating
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Body mass index | Asian Indian
Item
bmi ≥ 26 (patients of asian indian origin ≥ 22) kg/m2
boolean
C1305855 (UMLS CUI [1])
C1524069 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
hba1c ≥ 7.5%, ≤ 10.5%
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg ≥ 120 mg/dl, ≤ 240 mg/dl
boolean
C0583513 (UMLS CUI [1])
Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy
Item
history of diabetes secondary to pancreatitis or pancreatectomy
boolean
C0011849 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0030305 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0030279 (UMLS CUI [2,3])
Ketoacidosis
Item
any history of ketoacidosis
boolean
C0220982 (UMLS CUI [1])
Insulin use | Hospitalized patients Insulin use allowed
Item
history of insulin use within last one year (insulin use while hospitalized is acceptable)
boolean
C0240016 (UMLS CUI [1])
C0870668 (UMLS CUI [2,1])
C0240016 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Weight decreased Amount Timespan
Item
weight loss > 10 pounds in the three months prior to screening visit
boolean
C1262477 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Thiazolidinediones | Actos | Avandia
Item
history of tzd use (actos® or avandia®) within 6 months of screening visit
boolean
C1257987 (UMLS CUI [1])
C0875954 (UMLS CUI [2])
C0875967 (UMLS CUI [3])
Thiazolidinediones Discontinuation Due to Side effect | Thiazolidinediones Discontinuation Due to Lack of Efficacy
Item
history of tzd discontinuation due to side effect or lack of efficacy
boolean
C1257987 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0879626 (UMLS CUI [1,4])
C1257987 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0235828 (UMLS CUI [2,4])