Age | Postmenopausal state | Gender Contraceptive methods
Item
men or women at least 40 years old. women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Cardiovascular Disease | Coronary Artery Disease | Cerebrovascular Disorder | Peripheral Arterial Disease
Item
established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
boolean
C0007222 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
C1704436 (UMLS CUI [4])
Hemoglobin A1c measurement
Item
hba1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
boolean
C0474680 (UMLS CUI [1])
Informed Consent
Item
able and willing to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Renal Replacement Therapy
Item
severely reduced kidney function: egfr <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
C0206074 (UMLS CUI [3])
GLP-1 Receptor Agonist
Item
use of a glp-1 receptor agonist at screening.
boolean
C2917359 (UMLS CUI [1])
Gastroparesis Severe
Item
severe gastroparesis
boolean
C0152020 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pancreatitis | At risk Pancreatitis
Item
history of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
boolean
C0030305 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0030305 (UMLS CUI [2,2])
History of medullary carcinoma of thyroid | Family history Medullary carcinoma of thyroid | Multiple Endocrine Neoplasia Type | Islet Cell Tumor
Item
personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (men-2). personal history of pancreatic neuroendocrine tumours.
boolean
C1997422 (UMLS CUI [1])
C0241889 (UMLS CUI [2,1])
C0238462 (UMLS CUI [2,2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C0242363 (UMLS CUI [4])
Medical History Limiting Investigational Therapy | Medical History Limiting Completion of clinical trial
Item
medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.
boolean
C0262926 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Breast Feeding | Pregnancy | Pregnancy, Planned | Childbearing Potential Pregnancy Test
Item
breastfeeding, pregnancy, or planning a pregnancy during the course of the study. note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0032976 (UMLS CUI [4,2])
Hypersensitivity GLP-1 Receptor Agonist | Hypersensitivity Albiglutide Excipient
Item
known allergy to any glp-1 receptor agonist or excipients of albiglutide.
boolean
C0020517 (UMLS CUI [1,1])
C2917359 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2607479 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Investigational New Drugs | Study Subject Participation Status | Investigational Medical Device
Item
use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Study Subject Participation Status Inappropriate
Item
any other reason the investigator deems the subject to be unsuitable for the study.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])