Informed Consent
Item
1. provision of informed consent prior to any study specific procedures;
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Age
Item
2. men and women with t2dm aged >18 years;
boolean
C0011860 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body mass index
Item
3. bmi >25 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c 7.5-8.5 %;
boolean
C0474680 (UMLS CUI [1])
Metformin Dose U/day
Item
5. receiving metformin therapy (doses ranging from 1500 to 3000 mg daily) for at least 8 weeks.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
1. pregnancy or willingness to become pregnant;
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Liver Dysfunction Moderate | Liver Dysfunction Severe
Item
2. moderate and severe liver dysfunction;
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
RENAL FAILURE MODERATE | Kidney Failure Severe
Item
3. moderate and severe renal failure;
boolean
C0748307 (UMLS CUI [1])
C0035078 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Cardiovascular event Major
Item
4. previous major cardiovascular event;
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Communicable Diseases Severe | HIV Infection | Hepatitis B | Hepatitis C
Item
5. severe infections at the discretion of the investigator (such as human immunodeficiency virus [hiv], hepatitis b virus [hbv] and hepatitis c virus [hcv]);
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Malignant Neoplasms
Item
6. any malignancy;
boolean
C0006826 (UMLS CUI [1])
Plasma triglyceride measurement | Plasma LDL cholesterol measurement
Item
7. plasma triglycerides >400 mg/dl, plasma ldl-cholesterol > 250 mg/dl.
boolean
C0583329 (UMLS CUI [1])
C1278149 (UMLS CUI [2])