diabetes mellitus type 2
Item
type 2 diabetes according to the american diabetes association criteria.
boolean
C0011860 (UMLS CUI [1])
glimepiride
Item
treatment with glimepiride monotherapy (1-3 mg per day) 3 months before entering the study.
boolean
C0061323 (UMLS CUI [1])
HbA1c, fasting plasma glucose
Item
glycosylated hemoglobin greater than 6.5%, but less than 8.5% and/ or fasting plasma glucose greater than 7 mmol/l within the last 4 weeks.
boolean
C0019018 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
pregnancy, breast feeding, contraception
Item
females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
diabetes mellitus type 1
Item
type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
drug hypersensitivity
Item
history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
boolean
C0013182 (UMLS CUI [1])
progressive fatal diseases
Item
progressive fatal disease.
boolean
C0205082 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
drug or alcohol abuse
Item
history of drug or alcohol abuse during the last 5 years.
boolean
C0038586 (UMLS CUI [1])
severe hypoglycemia
Item
more than one unexplained episode of severe hypoglycemia within 6 months prior to entering the study.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric or hematological disease, macular edema
Item
a history of significant cardiovascular (new york heart association stage i - iv), respiratory, gastrointestinal, hepatic (alanine aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine greater than 1.8 mg/dl; glomerular filtration rate less than 40 ml/min as estimated by the cockroft-gault formula), neurological, psychiatric and/or hematological disease, history of macular edema.
boolean
C0007222 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0035204 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
C0023895 (UMLS CUI [4,1])
C0201836 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0201976 (UMLS CUI [5,2])
C0017654 (UMLS CUI [5,3])
C4064204 (UMLS CUI [5,4])
C0027765 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0018939 (UMLS CUI [8])
C0271051 (UMLS CUI [9])
blood donation
Item
blood donation within the last 30 days.
boolean
C0005794 (UMLS CUI [1])
medication or herbal treatment interfere with drug evaluation
Item
is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
boolean
C0013227 (UMLS CUI [1,1])
C1360419 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0013175 (UMLS CUI [1,4])
cyp2c9 inducers
Item
cyp2c9 inductors
boolean
C3850046 (UMLS CUI [1])
cyp2c9 inhibitors
Item
cyp2c9 inhibitors
boolean
C3850060 (UMLS CUI [1])
rifampicin
Item
rifampicin
boolean
C0035608 (UMLS CUI [1])
fluconazole
Item
fluconazole
boolean
C0016277 (UMLS CUI [1])
diabetes mellitus type 2 drugs
Item
drugs used for treating type 2 diabetes (insulin, insulin analogous compounds and oral antidiabetic drugs)
boolean
C0011860 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
thiazolidinediones
Item
pretreatment with thiazolidinediones within the last 12 months.
boolean
C1257987 (UMLS CUI [1])