Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Diet therapy Non-Insulin-Dependent Diabetes Mellitus | Glycosylated hemoglobin A Percentage
Item
diet-treated subjects with type 2 diabetes with hba1c 7.5-9.5 %
boolean
C0012159 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C0019018 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Antidiabetics Oral Non-Insulin-Dependent Diabetes Mellitus | Metformin | alpha-Glucosidase Inhibitors | Glycosylated hemoglobin A Percent
Item
subjects with type 2 diabetes in oral anti-diabetic drug (oad) monotherapy treated with metformin or alpha-glucosidase inhibitors with hba1c 7.0-9.5%
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
C1299007 (UMLS CUI [3])
C0019018 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) 18.5-40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Stable body weight
Item
subjects should have a stable body weight for at least 3 months prior to screening (as judged by the investigator)
boolean
C0517386 (UMLS CUI [1])
Liver Dysfunction
Item
impaired liver function
boolean
C0086565 (UMLS CUI [1])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Cardiovascular Diseases | Myocardial Infarction | Heart failure
Item
clinically significant active cardiovascular disease including history of myocardial infarction within the last 6 months and/or heart failure
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
Electrocardiogram abnormal
Item
any clinically significant abnormal ecg (electrocardiogram)
boolean
C0522055 (UMLS CUI [1])
Uncontrolled hypertension Treated | Uncontrolled hypertension untreated
Item
uncontrolled treated/untreated hypertension
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Recurrent severe hypoglycemia
Item
recurrent severe hypoglycaemia as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
active hepatitis b and/or active hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV antibody positive
Item
positive human immunodeficiency virus (hiv) antibodies
boolean
C0920548 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])