Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 2 diabetes mellitus, as defined by the american diabetes association, for at least one year at the time of screening.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glycosylated hemoglobin A
Item
hba1c measured at visit 1 in the range of ≥ 7.0 and < 9.0 %.
boolean
C0019018 (UMLS CUI [1])
Metformin Stable Dose U/day | Antidiabetics Other Excluded
Item
stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in the study). no other antidiabetic medications are permitted for 3 months prior to enrollment.
boolean
C0025598 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0935929 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Lacking
Item
women of childbearing potential not protected by medically approved contraceptive method of birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Body mass index
Item
bmi >40kg/m2
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus Excluded
Item
diabetes other than type 2 diabetes.
boolean
C0011849 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Brittle diabetes | Hospitalization Due to Diabetic - poor control | Emergency department patient visit Due to Diabetic - poor control | Dehydration Diabetes Related Hospitalization Required | Ketoacidosis
Item
subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis.
boolean
C0342302 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0421258 (UMLS CUI [2,3])
C0586082 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0421258 (UMLS CUI [3,3])
C0011175 (UMLS CUI [4,1])
C0011847 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C1708385 (UMLS CUI [4,4])
C0220982 (UMLS CUI [5])
Malignant Neoplasms
Item
presence or history of cancer within the past five years.
boolean
C0006826 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Retinal Diseases Requirement Laser Surgery | Heart failure Hospitalization Required
Item
evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0035309 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0023087 (UMLS CUI [3,3])
C0018801 (UMLS CUI [4,1])
C1708385 (UMLS CUI [4,2])
Liver Function Tests Impaired | Renal Insufficiency
Item
impaired hepatic tests, impaired renal function.
boolean
C0023901 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2])
Kidney Diseases | Urologic Diseases
Item
history or evidence of clinically relevant renal or urological disorder.
boolean
C0022658 (UMLS CUI [1])
C0042075 (UMLS CUI [2])
Exclusion Criteria Additional
Item
the investigator will evaluate whether there are other reasons why a patient may not participate.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])