ID

29242

Beschrijving

Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00978627

Link

https://clinicaltrials.gov/show/NCT00978627

Trefwoorden

Versies (1)
  1. 11-03-18 11-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 maart 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes NCT00978627

Engels

Eligibility Diabetes NCT00978627

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00978627
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
for the main trial, nn5401-3594:
Beschrijving

Period Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C1542147
type 1 diabetes mellitus for at least 12 months
Beschrijving

Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
Beschrijving

Insulin regime | Basal insulin Bolus | Other Coding | Other Coding

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C0650607
UMLS CUI [2,2]
C1705509
UMLS CUI [3]
C3846158
UMLS CUI [4]
C3846158
hba1c 7.0-10.0% (both inclusive)
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
bmi (body mass index) below or equal to 35.0 kg/m^2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
for the extension trial, nn5401-3645:
Beschrijving

Period Extension

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C0231448
the subject must have completed the six-month treatment period in trial nn5401-3594
Beschrijving

Therapeutic procedure Period Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2347804
UMLS CUI [1,3]
C0205197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
for the main trial, nn5401-3594:
Beschrijving

Period Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C1542147
treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
Beschrijving

Insulin regime | Exception Basal insulin Bolus

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0650607
UMLS CUI [2,3]
C1705509
cardiovascular disease within the last 6 months
Beschrijving

Cardiovascular Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
uncontrolled treated/untreated severe hypertension
Beschrijving

Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated

Datatype

boolean

Alias
UMLS CUI [1,1]
C4013784
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C4013784
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332155
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
cancer and medical history of cancer
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
for the extension trial, nn5401-3645:
Beschrijving

Period Extension

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C0231448
anticipated significant lifestyle changes during the trial
Beschrijving

Lifestyle changes Anticipated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0870811
UMLS CUI [1,2]
C3840775
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
Terug naar het begin van de pagina

Similar models

Eligibility Diabetes NCT00978627

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00978627
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial