Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for a minimum of 6 months prior to visit 1
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement | Hemoglobin A1c measurement Maximum
Item
hba1c at least 7.0 % - maximum 11 % at screening
boolean
C0474680 (UMLS CUI [1])
C0474680 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Insulin Absent | Insulin regime short-term allowed
Item
subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Diabetes Therapy Stable
Item
an antidiabetic regimen that has been stable for at least 3 months prior to screening
boolean
C3274787 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Diabetes Therapy | Antidiabetics Oral Quantity Minimum
Item
an antidiabetic regimen that includes a minimum of 2 oads
boolean
C3274787 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1524031 (UMLS CUI [2,4])
Antidiabetics Oral Dose
Item
oads dosed at least 50% of the maximum recommended dose
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Investigational New Drugs
Item
the receipt of any investigational medicinal product within one month prior to this trial
boolean
C0013230 (UMLS CUI [1])
Life threatening illness | Malignant Neoplasms
Item
suffer from a life threatening disease (cancer)
boolean
C3846017 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction Treated | Myocardial Infarction Untreated
Item
cardiac disease: class iii or iv congestive heart failure (chf), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
hepatic insufficiency (alanine aminotransferase (alt) or aspartate aminotransferase (ast) above 2 times the central laboratory's upper reference limit)
boolean
C1306571 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Recurrent hypoglycemia | Loss of hypoglycemic warning
Item
recurrent hypoglycaemia or hypoglycaemic unawareness
boolean
C1846288 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Anemia | Hemoglobin measurement
Item
anemia (haemoglobin below 10 mg/dl)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])