Diabetes Mellitus, Non-Insulin-Dependent
Item
has been diagnosed with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
has hemoglobin-specific a1c fraction (hba1c) of 7.1% to 11.0%, inclusive, at screening
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
has a body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
boolean
C1305855 (UMLS CUI [1])
Diet therapy | Exercise | Metformin Stable | Sulfonylurea Stable | Thiazolidinediones Stable | Combined Modality Therapy
Item
has been treated with diet and exercise alone or in combination with a stable regimen of metformin (met), a sulfonylurea (su), a thiazolidinedione (tzd), a combination of metformin and an su, a combination of metformin and a tzd, or a combination of an su and a tzd for a minimum of 2 months prior to screening
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C1257987 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0009429 (UMLS CUI [6])
Pharmaceutical Preparations Following Absent | Pharmaceutical Preparations Following Stable
Item
either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:
boolean
C0013227 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Hormone replacement therapy | Gender
Item
hormone replacement therapy (female subjects)
boolean
C0282402 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Contraceptives, Oral | Gender
Item
oral contraceptives (female subjects)
boolean
C0009905 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Antihypertensive Agents
Item
antihypertensive agents
boolean
C0003364 (UMLS CUI [1])
Hypolipidemic Agents
Item
lipid-lowering agents
boolean
C0086440 (UMLS CUI [1])
Thyroid hormone replacement therapy
Item
thyroid replacement therapy
boolean
C2242640 (UMLS CUI [1])
Antidepressive Agents
Item
antidepressant agents
boolean
C0003289 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Body Weight | orlistat | Xenical | sibutramine | Meridia | topiramate | Topamax | Over-the-counter Anti-Obesity Agents
Item
drugs known to affect body weight, including prescription medications (e.g. orlistat [xenical®], sibutramine [meridia®], topiramate [topamax®]) and over the counter antiobesity agents
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0076275 (UMLS CUI [2])
C0732649 (UMLS CUI [3])
C0074493 (UMLS CUI [4])
C0635898 (UMLS CUI [5])
C0076829 (UMLS CUI [6])
C0723778 (UMLS CUI [7])
C0013231 (UMLS CUI [8,1])
C0376607 (UMLS CUI [8,2])
Exposure to Exenatide | Exposure to Byetta | Exposure to GLP-1 analogues
Item
has ever been exposed to exenatide (exenatide once weekly [exenatide lar], exenatide bid, byetta, or any other formulation) or any glucagon-like peptide-1 (glp-1) analog
boolean
C0332157 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1636686 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C4301632 (UMLS CUI [3,2])
Investigational New Drugs
Item
has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
boolean
C0013230 (UMLS CUI [1])
Pharmaceutical Preparations Excluded
Item
has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Dipeptidyl-Peptidase IV Inhibitors
Item
any dipeptidyl peptidase 4 (dpp-4) inhibitor within 3 months prior to screening
boolean
C1827106 (UMLS CUI [1])
alpha-Glucosidase Inhibitors | Meglitinide | nateglinide | Pramlintide | Symlin
Item
alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (symlin®) within 30 days of screening
boolean
C1299007 (UMLS CUI [1])
C0065880 (UMLS CUI [2])
C0903898 (UMLS CUI [3])
C0537551 (UMLS CUI [4])
C1174780 (UMLS CUI [5])
Insulin
Item
insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
boolean
C0021641 (UMLS CUI [1])
CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Intravenous | CORTICOSTEROIDS FOR SYSTEMIC USE Intramuscular | Inhaled steroids | Steroids Intrapulmonary | Advair
Item
systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including advair®) steroids known to have a high rate of systemic absorption
boolean
C3653708 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C3653708 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4])
C0038317 (UMLS CUI [5,1])
C1522224 (UMLS CUI [5,2])
C0965130 (UMLS CUI [6])