Informed consent
Item
provision of informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Childbearing Potential | Postmenopausal state | Hysterectomy | Bilateral oophorectomy | Salpingectomy | Tubal Ligation | Age
Item
male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
C0278321 (UMLS CUI [5])
C0041271 (UMLS CUI [6])
C0520483 (UMLS CUI [7])
C0001779 (UMLS CUI [8])
Glycosylated hemoglobin A
Item
patients with hba1c ≥7.5 but ≤11% at enrolment visit (visit 1)
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
ody mass index >19 to <38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
he fasting plasma glucose should be in the range of 3-14 mmol/l (54-252 mg/dl, nclusive) on the morning of visit 1.
boolean
C0583513 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Diabetes Therapy Metformin
Item
metformin as only anti-diabetic treatment, at least for the last 3 months
boolean
C3274787 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
Disease Significant At risk Study Subject Participation Status | Disease Significant Affecting research results
Item
history or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Clinical Chemistry Tests Abnormality Significant | Hematology procedure Abnormality Significant | Urinalysis Abnormality Significant
Item
any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
boolean
C0525044 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0200627 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0042014 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis | serum glutamic acid decarboxylase (GAD) antibody test Positive
Item
aspartate aminotransferase (ast) or alanine aminotransferase (alt) laboratory results >3x upper level of normal range (uln) clinical diagnosis of type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive glutamic acid decarboxylase autoantibodies test (gad antibodies test).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
C0011880 (UMLS CUI [4])
C2208796 (UMLS CUI [5,1])
C1446409 (UMLS CUI [5,2])
Insulin regime Single
Item
patients treated with single insulin therapy within the last 3 months
boolean
C0557978 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])