Gender | Postmenopausal state | Female Sterilization | Diabetes Mellitus, Non-Insulin-Dependent
Item
males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
Stable status Medical | Physical Examination | Medical History | Laboratory Results | Taking vital signs | Electrocardiography
Item
medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ecg performed at screening
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C1254595 (UMLS CUI [4])
C0150404 (UMLS CUI [5])
C1623258 (UMLS CUI [6])
Body mass index
Item
body mass index (bmi) between 22 and 39.9 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Hypoglycemic Agents Stable | Glucohemoglobin measurement | Oral hypoglycemic Single | Metformin | Sulfonylurea | Meglitinide | repaglinide | nateglinide | Dipeptidyl Peptidase 4 Inhibitors | sitagliptin | vildagliptin | alpha-Glucosidase Inhibitors | Acarbose | Low-Dose Treatment Oral hypoglycemic Double
Item
on a generally stable antihyperglycemic agent regimen (i.e., with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to the screening visit, including volunteers who are:(a) not currently on antihyperglycemic therapy and have an hba1c =7.0% and =10.0%, or (b) on a single oral antihyperglycemic agent [metformin, a sulfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a dpp-4 inhibitor (sitagliptin or vildagliptin), or an alpha-glucosidase inhibitor (e.g., acarbose)] and have an hba1c >=6.5% and <=9.5%, or (c) on low-dose dual oral agent therapy (i.e., <50% maximum labeled doses of both agents) and have an hba1c >=6.5% and <=9.5%
boolean
C0020616 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
C0359086 (UMLS CUI [3,1])
C0205171 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C0065880 (UMLS CUI [6])
C0246689 (UMLS CUI [7])
C0903898 (UMLS CUI [8])
C2917254 (UMLS CUI [9])
C1565750 (UMLS CUI [10])
C1570906 (UMLS CUI [11])
C1299007 (UMLS CUI [12])
C0050393 (UMLS CUI [13])
C1708745 (UMLS CUI [14,1])
C0359086 (UMLS CUI [14,2])
C0205173 (UMLS CUI [14,3])
Plasma fasting glucose measurement
Item
on day -1, fpg concentrations between 120 mg/dl and 260 mg/dl, inclusive.
boolean
C0583513 (UMLS CUI [1])
Hypoglycemic Agents | Insulin | exenatide | GLP-1 Analogue | Thiazolidinediones | Peroxisome Proliferator-activated Receptor gamma Agonists
Item
taking non-oral antihyperglycemic agent (e.g., insulin, exenatide or other glp-1 analogues), or taking a thiazolidinedione (i.e., a pparg agonist) within 3 months of day -1
boolean
C0020616 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0167117 (UMLS CUI [3])
C3273809 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
C2916798 (UMLS CUI [6])
Hypoglycaemic episode Severe | Hypoglycaemic episode Recurrent | Loss of hypoglycemic warning
Item
history of a recent severe hypoglycemic episode, recurrent hypoglycemic episodes (i.e., within the past year), or a history of hypoglycemic unawareness
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0745153 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0342317 (UMLS CUI [3])
Complications of Diabetes Mellitus | Retinal Diseases | Kidney Diseases | Neuropathy | Gastroparesis
Item
history of clinically significant diabetic complications, including retinopathy, nephropathy, neuropathy or gastroparesis
boolean
C0342257 (UMLS CUI [1])
C0035309 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0442874 (UMLS CUI [4])
C0152020 (UMLS CUI [5])
Substance Use Disorder Test Positive
Item
positive test for alcohol and/or drugs of abuse
boolean
C0038586 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Mental problem Informed Consent Invalid | Mental problem Protocol Compliance Limited
Item
psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
boolean
C0848067 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1547465 (UMLS CUI [1,3])
C0848067 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Condition compromises Patient safety | Condition compromises Clinical Trial | Condition Preventing Protocol Compliance
Item
any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])