Period Main
Item
for the main trial, nn5401-3594:
boolean
C2347804 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin regime | Basal insulin Bolus | Other Coding | Other Coding
Item
ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
boolean
C0557978 (UMLS CUI [1])
C0650607 (UMLS CUI [2,1])
C1705509 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
Glucohemoglobin measurement
Item
hba1c 7.0-10.0% (both inclusive)
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) below or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Period Extension
Item
for the extension trial, nn5401-3645:
boolean
C2347804 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Therapeutic procedure Period Completion
Item
the subject must have completed the six-month treatment period in trial nn5401-3594
boolean
C0087111 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Period Main
Item
for the main trial, nn5401-3594:
boolean
C2347804 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Insulin regime | Exception Basal insulin Bolus
Item
treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0650607 (UMLS CUI [2,2])
C1705509 (UMLS CUI [2,3])
Cardiovascular Disease
Item
cardiovascular disease within the last 6 months
boolean
C0007222 (UMLS CUI [1])
Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated
Item
uncontrolled treated/untreated severe hypertension
boolean
C4013784 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C4013784 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms
Item
cancer and medical history of cancer
boolean
C0006826 (UMLS CUI [1])
Period Extension
Item
for the extension trial, nn5401-3645:
boolean
C2347804 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Lifestyle changes Anticipated
Item
anticipated significant lifestyle changes during the trial
boolean
C0870811 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])