Information:
Fel:
ID
38861
Beskrivning
Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01074268
Länk
https://clinicaltrials.gov/show/NCT01074268
Nyckelord
Versioner (1)
- 2019-11-10 2019-11-10 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
10 november 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes NCT01074268
Eligibility Diabetes NCT01074268
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT01074268
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
C0872146 (UMLS CUI [1,2])
Basal insulin Bolus
Item
current treatment with any basal bolus insulin for at least 12 months
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C1705509 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c below or equal to 10.0%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Japan | Age Minimum
Item
for japan only: minimum age is 20 years
boolean
C0022341 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
C0001779 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
Extension Trial | Treatment completed Clinical Trial Specified
Item
for the extension trial only: completed the six-month treatment period in trial nn1250-3585 (nct01074268)
boolean
C0231448 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0580352 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0008976 (UMLS CUI [1,2])
C0580352 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Antidiabetics | Exception Insulin
Item
use of any other antidiabetic drug than insulin within the last 3 months
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
Cardiovascular Disease
Item
cardiovascular disease within the last 6 months
boolean
C0007222 (UMLS CUI [1])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated
Item
uncontrolled treated/untreated severe hypertension
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0011880 (UMLS CUI [3,2])
C0342317 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0011880 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Pregnancy intended | 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])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms | History of cancer
Item
cancer and medical history of cancer
boolean
C0006826 (UMLS CUI [1])
C0455471 (UMLS CUI [2])
C0455471 (UMLS CUI [2])