Age
Item
male or female subjects ≥18 and ≤75 years of age
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Stable | Sulfonylurea Dose Stable | Combined Modality Therapy
Item
currently treated with metformin, a sulfonylurea, or combination metformin/sulfonylurea; stable dose for ≥3 months
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
hba1c of 7.0-9.0% inclusive
boolean
C0474680 (UMLS CUI [1])
Hypolipidemic Agents Dose Stable
Item
if taking lipid lowering medications, stable dose for >30 days
boolean
C0086440 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Prednisone Oral Product | Prednisone Injection | Cortisone Oral Product | Cortisone Injection | Topical steroids allowed | Inhaled steroids allowed
Item
taken oral or injected prednisone or cortisone medications in the previous 30 days. (topical or inhaled steroids will not be considered excluded medications.)
boolean
C3216040 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C3209977 (UMLS CUI [3])
C0010137 (UMLS CUI [4,1])
C1828121 (UMLS CUI [4,2])
C2064827 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C2065041 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Insulin | Thiazolidinediones | Incretins
Item
current use of insulin or tzd's, or incretins
boolean
C0021641 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C1562292 (UMLS CUI [3])
Low density lipoprotein measurement
Item
ldl <70 mg/dl
boolean
C0202116 (UMLS CUI [1])
Serum Triglyceride Measurement
Item
serum triglycerides >500 mg/dl
boolean
C0542495 (UMLS CUI [1])
Pancreatitis Hypertriglyceridemia Induced
Item
history of hypertriglyceridemia-induced pancreatitis
boolean
C0030305 (UMLS CUI [1,1])
C0020557 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])
Gastrointestinal Disease | Deglutition Disorders | Deranged intestinal motility | Intestinal Obstruction
Item
history of gastrointestinal disorder such as dysphagia, swallowing disorder, intestinal motility disorder or prior bowel obstruction
boolean
C0017178 (UMLS CUI [1])
C0011168 (UMLS CUI [2])
C0232673 (UMLS CUI [3])
C0021843 (UMLS CUI [4])
Medical condition Severe compromises Patient safety | Severe Mental Disorder compromises Patient safety | Chronic condition compromises Patient safety | Chronic infectious disease compromises Patient safety | Medical condition Severe compromises Study Subject Participation Status | Severe Mental Disorder compromises Study Subject Participation Status | Chronic condition compromises Study Subject Participation Status | Chronic infectious disease compromises Study Subject Participation Status
Item
history or presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the subject's safety or successful participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C4046029 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C4315615 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0151317 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C2945640 (UMLS CUI [5,3])
C2348568 (UMLS CUI [5,4])
C4046029 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C4315615 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0151317 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
Protocol Compliance Unable
Item
unable to follow the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Lacking Able to speak English Language | Lacking Able to read English Language | Lacking Able to write English Language
Item
unable to speak, read and write in english
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0586740 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C0584993 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnant, planning to become pregnant, breast feeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])