Informed Consent
Item
1. written consent has been given.
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable
Item
2. patients with type 2 diabetes treated with a stable dose of metformin during the last three months
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Age
Item
3. age 20-70 years.
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c 6.5-8.5% (48-67 mmol/mol) at visit 1.
boolean
C0474680 (UMLS CUI [1])
Completion of clinical trial Able
Item
5. ability to complete the study
boolean
C2732579 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Hypoglycemic Agents | Exception Metformin
Item
1. use of other glucose-lowering therapy than metformin within three months prior to visit 1.
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Secondary diabetes mellitus | Cushing Syndrome | Acromegaly
Item
2. a history of any secondary forms of diabetes, e.g., cushing's syndrome and acromegaly.
boolean
C0271640 (UMLS CUI [1])
C0010481 (UMLS CUI [2])
C0001206 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Anti-GAD antibody positive
Item
3. type 1 diabetes, positive gad antibodies
boolean
C0011854 (UMLS CUI [1])
C1167896 (UMLS CUI [2])
Estimated Glomerular Filtration Rate
Item
4. estimated glomerular filtration rate <60 ml/min
boolean
C3811844 (UMLS CUI [1])
Communicable Diseases Affecting Blood Glucose Control
Item
5. acute infections which may affect blood glucose control within 4 weeks prior to visit 1
boolean
C0009450 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
C0243148 (UMLS CUI [1,4])
Hypoglycaemic episode Recurrent | Hypoglycaemic episode Severe
Item
6. any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
boolean
C0745153 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pancreatitis
Item
7. any history of acute pancreatitis
boolean
C0030305 (UMLS CUI [1])
Anaphylaxis | Angioedema | Skin condition Exfoliative | Stevens-Johnson Syndrome
Item
8. any history of anaphylaxis, angioedema, and exfoliative skin conditions including stevens-johnson syndrome.
boolean
C0002792 (UMLS CUI [1])
C0002994 (UMLS CUI [2])
C1719933 (UMLS CUI [3,1])
C0205226 (UMLS CUI [3,2])
C0038325 (UMLS CUI [4])
Liver disease | Liver Cirrhosis | Hepatitis, Chronic
Item
9. liver disease such as cirrhosis or chronic active hepatitis
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
Coronary heart disease | Heart failure New York Heart Association Classification
Item
10. history of coronary heart disease or heart failure class iii or iv
boolean
C0010068 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Blood Donation Unit Quantity | Blood Loss Unit Quantity | Blood Transfusion
Item
11. donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
boolean
C0005794 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3163616 (UMLS CUI [2,1])
C0439148 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0005841 (UMLS CUI [3])
Growth hormone treatment | Steroid therapy oral chronic | Steroid therapy parenteral chronic
Item
12. treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
boolean
C0744483 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0149783 (UMLS CUI [3,1])
C1518896 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
Investigational New Drugs Inappropriate Clinical Trial
Item
13. use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
boolean
C0013230 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Hypersensitivity Vildagliptin | Hypersensitivity Dapagliflozin | Hypersensitivity Compound Investigational New Drugs
Item
14. hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core
boolean
C0020517 (UMLS CUI [1,1])
C1570906 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2353951 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])