Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for at least 6 months before trial start
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metformin U/day
Item
treatment with at least 1000 mg metformin per day for at least 3 months
boolean
C0025598 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Insulin naive | Insulin short-term allowed
Item
insulin-naive (short-term insulin treatment of up to 14 days is allowed)
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Dipeptidyl Peptidase-4 Inhibitor naive
Item
dpp-4 (dipeptidyl peptidase-4) inhibitor naive
boolean
C3537225 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin a1c) between 7.5-10.0% by central laboratory analysis
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) lesser than or equal to 45.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Subcutaneous Injections Quantity per day Able | Subcutaneous Injections Quantity per day Willing
Item
able and willing to take one subcutaneous injection every day
boolean
C0021499 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
C0021499 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439505 (UMLS CUI [2,3])
C0600109 (UMLS CUI [2,4])
Plasma Glucose Measurement Self Able | Plasma Glucose Measurement Self Willing
Item
able and willing to perform mandatory smpg (self measured plasma glucose) measurements
boolean
C0202042 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Intolerance to Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related | Intolerance to Pharmaceutical Preparations Related
Item
known or suspected allergy or intolerance to any of the trial products 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])
C1744706 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C0439849 (UMLS CUI [5,4])
C1744706 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C0439849 (UMLS CUI [6,3])
Hypertension, severe
Item
severe hypertension
boolean
C4013784 (UMLS CUI [1])
Thiazolidinediones | GLP-1 Mimetics
Item
treatment with thiazolidinedione (tzd) or glp-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
boolean
C1257987 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
Heart Disease
Item
cardiac disease, within the last 12 months
boolean
C0018799 (UMLS CUI [1])
Liver Dysfunction
Item
impaired hepatic function
boolean
C0086565 (UMLS CUI [1])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Proliferative retinopathy Treatment required for | Macular retinal edema Treatment required for
Item
proliferative retinopathy or macular oedema requiring acute treatment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0271051 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Childbearing Potential
Item
female of childbearing potential
boolean
C3831118 (UMLS CUI [1])
Alcohol abuse | Narcotic Abuse | DRUG ABUSE ILLICIT | Alcohol abuse Suspected | Narcotic Abuse Suspected | DRUG ABUSE ILLICIT Suspected
Item
known or suspected abuse of alcohol, narcotics or illicit substances
boolean
C0085762 (UMLS CUI [1])
C0524661 (UMLS CUI [2])
C0743253 (UMLS CUI [3])
C0085762 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0524661 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0743253 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])