ID

38918

Descripción

A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01467414

Link

https://clinicaltrials.gov/show/NCT01467414

Palabras clave

Versiones (1)
  1. 12/11/19 12/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT01467414

Inglés

Eligibility Diabetes NCT01467414

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01467414
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female japanese subject aged 20-70 years (both inclusive)
Descripción

Japanese | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2]
C0001779
japanese passport holder
Descripción

Passport Japanese holder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3242633
UMLS CUI [1,2]
C1556094
UMLS CUI [1,3]
C1555310
japanese-born parents
Descripción

Parent Japanese

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C1556094
type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
Descripción

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treated with insulin for at least 3 months
Descripción

Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
body mass index (bmi) maximum 33.0 kg/m^2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
glycosylated haemoglobin a1c (hba1c) maximum 10.0%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
fasting c-peptide below 1.0 nmol/l
Descripción

Fasting C-peptide level

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2208720
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of oral antidiabetic drugs (oads) and/or glucagon like peptide-1 (glp-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
Descripción

Antidiabetics Oral | GLP-1 Receptor Agonist | exenatide | liraglutide

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C2917359
UMLS CUI [3]
C0167117
UMLS CUI [4]
C1456408
subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening
Descripción

Blood Donation Recent | Plasma Donation Recent | Blood Donation Amount Timespan | Plasma Donation Amount Timespan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0680854
UMLS CUI [2,3]
C0332185
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0872291
UMLS CUI [4,1]
C0032105
UMLS CUI [4,2]
C0680854
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0872291
not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Descripción

Refrain from Smoking Unable | Refrain from Smoking Unwilling | Use of Nicotine Chewing Gum Discontinue Unable | Use of Nicotine Chewing Gum Discontinue Unwilling | Use of Nicotine Transdermal Patch Discontinue Unable | Use of Nicotine Transdermal Patch Discontinue Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4086797
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C4086797
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0599654
UMLS CUI [3,3]
C1444662
UMLS CUI [3,4]
C1299582
UMLS CUI [4,1]
C1524063
UMLS CUI [4,2]
C0599654
UMLS CUI [4,3]
C1444662
UMLS CUI [4,4]
C0558080
UMLS CUI [5,1]
C1524063
UMLS CUI [5,2]
C0358855
UMLS CUI [5,3]
C1444662
UMLS CUI [5,4]
C1299582
UMLS CUI [6,1]
C1524063
UMLS CUI [6,2]
C0358855
UMLS CUI [6,3]
C1444662
UMLS CUI [6,4]
C0558080
supine blood pressure at screening (after resting for 5 min) minimum 180 mmhg for systolic and/or minimum 100 mmhg for diastolic
Descripción

Lying systolic blood pressure | Lying diastolic blood pressure | Status post Resting Number of minutes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1319895
UMLS CUI [2]
C1319896
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0035253
UMLS CUI [3,3]
C1562039
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Similar models

Eligibility Diabetes NCT01467414

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01467414
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Japanese | Age
Item
male or female japanese subject aged 20-70 years (both inclusive)
boolean
C1556094 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Passport Japanese holder
Item
japanese passport holder
boolean
C3242633 (UMLS CUI [1,1])
C1556094 (UMLS CUI [1,2])
C1555310 (UMLS CUI [1,3])
Parent Japanese
Item
japanese-born parents
boolean
C0030551 (UMLS CUI [1,1])
C1556094 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin regime
Item
treated with insulin for at least 3 months
boolean
C0557978 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) maximum 33.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin a1c (hba1c) maximum 10.0%
boolean
C0474680 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting c-peptide below 1.0 nmol/l
boolean
C2208720 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | GLP-1 Receptor Agonist | exenatide | liraglutide
Item
use of oral antidiabetic drugs (oads) and/or glucagon like peptide-1 (glp-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2917359 (UMLS CUI [2])
C0167117 (UMLS CUI [3])
C1456408 (UMLS CUI [4])
Blood Donation Recent | Plasma Donation Recent | Blood Donation Amount Timespan | Plasma Donation Amount Timespan
Item
subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening
boolean
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0872291 (UMLS CUI [3,3])
C0032105 (UMLS CUI [4,1])
C0680854 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0872291 (UMLS CUI [4,4])
Refrain from Smoking Unable | Refrain from Smoking Unwilling | Use of Nicotine Chewing Gum Discontinue Unable | Use of Nicotine Chewing Gum Discontinue Unwilling | Use of Nicotine Transdermal Patch Discontinue Unable | Use of Nicotine Transdermal Patch Discontinue Unwilling
Item
not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
boolean
C4086797 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C1524063 (UMLS CUI [3,1])
C0599654 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
C1524063 (UMLS CUI [4,1])
C0599654 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
C0558080 (UMLS CUI [4,4])
C1524063 (UMLS CUI [5,1])
C0358855 (UMLS CUI [5,2])
C1444662 (UMLS CUI [5,3])
C1299582 (UMLS CUI [5,4])
C1524063 (UMLS CUI [6,1])
C0358855 (UMLS CUI [6,2])
C1444662 (UMLS CUI [6,3])
C0558080 (UMLS CUI [6,4])
Lying systolic blood pressure | Lying diastolic blood pressure | Status post Resting Number of minutes
Item
supine blood pressure at screening (after resting for 5 min) minimum 180 mmhg for systolic and/or minimum 100 mmhg for diastolic
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0035253 (UMLS CUI [3,2])
C1562039 (UMLS CUI [3,3])
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