Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus for more than 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin a1c) between 7.5 % and 10.0% at trial initiation (screening)
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) less than 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Basal insulin | NPH insulin Frequency Daily | Insulin Glargine Frequency Daily | Insulin detemir Frequency Daily
Item
basal insulin treatment for at least 3 months (nph once or twice daily, insulin glargine or detemir once daily)
boolean
C0650607 (UMLS CUI [1])
C0021658 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0907402 (UMLS CUI [3,1])
C0439603 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
C0537270 (UMLS CUI [4,1])
C0439603 (UMLS CUI [4,2])
C0332173 (UMLS CUI [4,3])
Antidiabetics Oral Quantity
Item
treatment with one to 3 oads
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (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 allergy to 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])
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, Planned
Item
women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status
Item
previous participation in any trial including this for the last 6 months
boolean
C2348568 (UMLS CUI [1])
Basal insulin Dosage per day
Item
use of more than 1 u/kg of basal insulin daily at trial initiation (screening)
boolean
C0650607 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])