Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
duration of type 2 diabetes for at least 6 months since diagnosis
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Oral hypoglycemic Quantity | Intermediate-acting insulin U/day | Long-Acting Insulin U/day
Item
current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0304869 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0304870 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
Body mass index
Item
bmi below 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c between 7-12%
boolean
C0019018 (UMLS CUI [1])
Self Monitoring Capillary blood glucose measurement Willing
Item
able and willing to perform self-monitoring of capillary blood glucose
boolean
C0588436 (UMLS CUI [1,1])
C0457578 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Oral hypoglycemic Quantity
Item
current antidiabetic treatment with combination of three or more oral antidiabetic drugs
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Insulin, Short-Acting | Biphasic Insulins
Item
previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
boolean
C0356365 (UMLS CUI [1])
C0356369 (UMLS CUI [2])
Loss of hypoglycemic warning | Recurrent severe hypoglycemia
Item
known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator
boolean
C0342317 (UMLS CUI [1])
C0342316 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs
Item
known or suspected allergy to trial product 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])
C0013230 (UMLS CUI [2,4])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Inadequate
Item
pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
Investigational New Drugs
Item
receipt of any investigational drug within 4 weeks prior to this trial
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status
Item
previous participation in this trial
boolean
C2348568 (UMLS CUI [1])