Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes for at least 6 months
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Stable | Thiazolidinediones Dose Stable
Item
treated with metformin and/or thiazolidinediones with stable dose for at least 3 months
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1257987 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Body mass index
Item
bmi of 21-45 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c level of 7.50 - 10.00%, inclusive
boolean
C0202054 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
if a female of childbearing potential, willing to utilize contraception from screening through 4 weeks after the last dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Insulin | Sulfonylurea | Dipeptidyl-Peptidase IV Inhibitors | Symlin | GLP-1 Analogue
Item
treatment with insulin, sulfonylurea, dpp-4 inhibitors, symlin® and/or glp-1 analogues ≤ 3 months prior to the screening
boolean
C0021641 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C1827106 (UMLS CUI [3])
C1174780 (UMLS CUI [4])
C3273809 (UMLS CUI [5])
Hypoglycemia Severe | Loss of hypoglycemic warning
Item
severe hypoglycemia ≤ 60 days prior to the screening visit or currently diagnosed with having hypoglycemia unawareness
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0342317 (UMLS CUI [2])
Gastric ulcer | Gastrointestinal Hemorrhage | Gastrointestinal perforation
Item
history of peptic ulcer(s) and/or gastrointestinal bleeding/perforation
boolean
C0038358 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0151664 (UMLS CUI [3])
Operation on stomach | Gastric Bypass | Gastric Bypass Planned | Major surgery Planned
Item
previous gastric surgery, including gastric bypass, or has gastric bypass/other major surgery planned to occur during the 10 month trial
boolean
C0192398 (UMLS CUI [1])
C0017125 (UMLS CUI [2])
C0017125 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0679637 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Myocardial Infarction | Congestive heart failure New York Heart Association Classification | Chronic atrial fibrillation
Item
myocardial infarction within the last 2 years, current congestive heart failure with nyha class 2 or greater, or chronic atrial fibrillation
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0694539 (UMLS CUI [3])
Illness Clinical Significance | Chronic disease
Item
current clinically significant and/or chronic illness
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
Non-Steroidal Anti-Inflammatory Agents Regular
Item
takes regular courses of non-steroidal anti-inflammatory drugs (nsaids). if these medications are discontinued upon starting screening procedures and are not planned to be regularly used during the trial, the patient will be allowed to enter the study
boolean
C0003211 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Suppository | CORTICOSTEROIDS FOR SYSTEMIC USE Injection | CORTICOSTEROIDS FOR SYSTEMIC USE Inhalation allowed | Topical corticosteroids allowed
Item
use of systemic corticosteroids (oral, suppository, injected). use of inhaled or topical corticosteroids is permitted
boolean
C3653708 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2,1])
C0038854 (UMLS CUI [2,2])
C3653708 (UMLS CUI [3,1])
C1828121 (UMLS CUI [3,2])
C3653708 (UMLS CUI [4,1])
C0205535 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0304604 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])