Healthy Volunteers | Non-Insulin-Dependent Diabetes Mellitus disease length | Antidiabetics Absent | Metformin | Thiazolidinediones
Item
they can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. t2dm subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a tzd (thiazolidinedione).
boolean
C1708335 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
Body mass index
Item
subjects must have a bmi between 25 and 40 kg/m² and weigh at least 50kg.
boolean
C1305855 (UMLS CUI [1])
Gender Infertility
Item
women must be of non-childbearing potential.
boolean
C0079399 (UMLS CUI [1,1])
C0021359 (UMLS CUI [1,2])
Hematologic Tests Criteria Fulfill | Serum total cholesterol measurement
Item
bloodwork that meets certain criteria (for example, total cholesterol > 240 mg/dl)
boolean
C0018941 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1445957 (UMLS CUI [2])
Elevated liver enzymes
Item
clinically significant hepatic enzyme elevation
boolean
C0235996 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c less than 6.5 or greater than 10
boolean
C0019018 (UMLS CUI [1])
Hepatitis B surface antigen positive | Hepatitis C positive | HIV Seropositivity
Item
positive test result for hepatitis b surface antigen, positive hepatitis c or hiv
boolean
C0149709 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Illness Major | Diabetes Mellitus Excluded
Item
any major illness other than diabetes
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Insulin | Diabetes Therapy
Item
previous use of insulin as treatment for diabetes
boolean
C0021641 (UMLS CUI [1])
C3274787 (UMLS CUI [2])
Kidney Disease Laboratory Procedures
Item
significant renal disease as defined by screening lab tests
boolean
C0022658 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Drug Allergy Study Subject Participation Status Exclusion | Hypersensitivity Study Subject Participation Status Exclusion
Item
history of drug or other allergy which in the opinion of the investigator contradicts subject participation
boolean
C0013182 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Tobacco use | Nicotine product
Item
smoking or use of nicotine-containing products within the previous 6 months
boolean
C0543414 (UMLS CUI [1])
C0028040 (UMLS CUI [2])
Substance Use Disorders
Item
history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Alcohol Abstinence Unwilling | Inpatient Hospital Stay
Item
unwilling to abstain from alcohol prior to and during the in-patient clinic stays
boolean
C0678274 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021562 (UMLS CUI [2,1])
C3489408 (UMLS CUI [2,2])
Caffeine product Abstinence Unwilling | Xanthine product Abstinence Unwilling | Inpatient Hospital Stay
Item
unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays
boolean
C0006644 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0043314 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0021562 (UMLS CUI [3,1])
C3489408 (UMLS CUI [3,2])
Hypericum perforatum
Item
use of st. john's wort during the study
boolean
C0936242 (UMLS CUI [1])
Blood Donation Blood Dosage | Blood Donation Planned
Item
has donated 500 nl or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
boolean
C0005794 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0005794 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])