ID

29242

Description

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

Keywords

Versions (1)
  1. 3/11/18 3/11/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 11, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00978627

English

Eligibility Diabetes NCT00978627

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00978627
Inclusion Criteria
Description

Inclusion Criteria

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

Period Main

Data type

boolean

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

Insulin-Dependent Diabetes Mellitus Disease length

Data type

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
Description

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

Data type

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)
Description

Glucohemoglobin measurement

Data type

boolean

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

Body mass index

Data type

boolean

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

Period Extension

Data type

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
Description

Therapeutic procedure Period Completion

Data type

boolean

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

Exclusion Criteria

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

Period Main

Data type

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
Description

Insulin regime | Exception Basal insulin Bolus

Data type

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
Description

Cardiovascular Disease

Data type

boolean

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

Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated

Data type

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
Description

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

Data type

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
Description

Malignant Neoplasms

Data type

boolean

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

Period Extension

Data type

boolean

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

Lifestyle changes Anticipated

Data type

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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
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Similar models

Eligibility Diabetes NCT00978627

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00978627
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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