ID

33714

Beschreibung

A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01135927

Link

https://clinicaltrials.gov/show/NCT01135927

Stichworte

Versionen (1)
  1. 20.12.18 20.12.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. Dezember 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT01135927

Englisch

Eligibility Diabetes NCT01135927

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01135927
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Beschreibung

Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (csii) for at least 12 months
Beschreibung

Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C0393124
current daily basal insulin requirement above or equal to 0.3 (i)u/kg/day
Beschreibung

Insulin Basal Dose Daily

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0205112
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0332173
glycosylated haemoglobin a1c (hba1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening
Beschreibung

Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount

Datentyp

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0005794
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0032105
UMLS CUI [4,2]
C0005794
UMLS CUI [4,3]
C1265611
surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to screening
Beschreibung

Operative Surgical Procedures Blood Loss Amount | Trauma Blood Loss Amount

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C3163616
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3714660
UMLS CUI [2,2]
C3163616
UMLS CUI [2,3]
C1265611
smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
Beschreibung

Tobacco use Number of cigarettes per day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period (only clamp period)
Beschreibung

Refrain from Smoking Unable | Refrain from Smoking Unwilling | Nicotine Gum Unable to discontinue | Nicotine Transdermal Patch Unable to discontinue | Nicotine Gum Discontinue Unwilling | Nicotine Transdermal Patch Discontinue Unwilling

Datentyp

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]
C0599654
UMLS CUI [3,2]
C1548265
UMLS CUI [4,1]
C0358855
UMLS CUI [4,2]
C1548265
UMLS CUI [5,1]
C0599654
UMLS CUI [5,2]
C1444662
UMLS CUI [5,3]
C0558080
UMLS CUI [6,1]
C0358855
UMLS CUI [6,2]
C1444662
UMLS CUI [6,3]
C0558080
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Ähnliche Modelle

Eligibility Diabetes NCT01135927

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01135927
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin
Item
treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (csii) for at least 12 months
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0393124 (UMLS CUI [2])
Insulin Basal Dose Daily
Item
current daily basal insulin requirement above or equal to 0.3 (i)u/kg/day
boolean
C0021641 (UMLS CUI [1,1])
C0205112 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin a1c (hba1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount
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])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0005794 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Operative Surgical Procedures Blood Loss Amount | Trauma Blood Loss Amount
Item
surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to screening
boolean
C0543467 (UMLS CUI [1,1])
C3163616 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3714660 (UMLS CUI [2,1])
C3163616 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Tobacco use Number of cigarettes per day
Item
smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Refrain from Smoking Unable | Refrain from Smoking Unwilling | Nicotine Gum Unable to discontinue | Nicotine Transdermal Patch Unable to discontinue | Nicotine Gum Discontinue Unwilling | 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 (only clamp period)
boolean
C4086797 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0599654 (UMLS CUI [3,1])
C1548265 (UMLS CUI [3,2])
C0358855 (UMLS CUI [4,1])
C1548265 (UMLS CUI [4,2])
C0599654 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
C0358855 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
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