ID

12003

Beschreibung

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02500706

Link

https://clinicaltrials.gov/show/NCT02500706

Stichworte

  1. 31.08.15 31.08.15 -
Rechteinhaber

ODM derived from: https://clinicaltrials.gov/show/NCT02500706

Hochgeladen am

31. August 2015

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Diabetes NCT02500706

Eligibility Diabetes NCT02500706

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02500706
Inclusion Criteria
Beschreibung

Inclusion Criteria

male or female, age greater than or equal to 18 years (for japan and taiwan: age greater than or equal to 20 years) at the time of signing informed consent
Beschreibung

age greater than or equal to 60 years; informed consent; female; taiwan; japan; time

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0682069
type 1 diabetes mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening
Beschreibung

type 1 diabetes mellitus; laboratory; screening; clinical; local; per

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (visit 1)
Beschreibung

screening; insulin; regimen; visit

Datentyp

boolean

Alias
UMLS CUI [1]
C0021641
currently treated with a basal insulin analogue for at least 4 months prior to screening (visit 1)
Beschreibung

screening; insulin; visit

Datentyp

boolean

Alias
UMLS CUI [1]
C0650607
hba1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
Beschreibung

laboratory; hba1c; both

Datentyp

boolean

Alias
UMLS CUI [1]
C0019018
body mass index less than or equal to 35.0 kg/m^2
Beschreibung

body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack
Beschreibung

myocardial infarction; unstable angina; hospitalization; stroke

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0038454
subjects presently classified as being in new york heart association (nyha) class iv currently planned coronary, carotid or peripheral artery revascularisation
Beschreibung

new york heart association classification; class iv; planned

Datentyp

boolean

Alias
UMLS CUI [1]
C1882087
UMLS CUI [2]
C3203629
diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (visit 1)
Beschreibung

ketoacidosis; screening; diabetic; visit; last

Datentyp

boolean

Alias
UMLS CUI [1]
C0011880
Inclusion Criteria
Beschreibung

Inclusion Criteria

Ähnliche Modelle

Eligibility Diabetes NCT02500706

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02500706
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
age greater than or equal to 60 years; informed consent; female; taiwan; japan; time
Item
male or female, age greater than or equal to 18 years (for japan and taiwan: age greater than or equal to 20 years) at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0682069 (UMLS CUI [2])
type 1 diabetes mellitus; laboratory; screening; clinical; local; per
Item
type 1 diabetes mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening
boolean
C0011854 (UMLS CUI [1])
screening; insulin; regimen; visit
Item
currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (visit 1)
boolean
C0021641 (UMLS CUI [1])
screening; insulin; visit
Item
currently treated with a basal insulin analogue for at least 4 months prior to screening (visit 1)
boolean
C0650607 (UMLS CUI [1])
laboratory; hba1c; both
Item
hba1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
boolean
C0019018 (UMLS CUI [1])
body mass index
Item
body mass index less than or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
myocardial infarction; unstable angina; hospitalization; stroke
Item
within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
new york heart association classification; class iv; planned
Item
subjects presently classified as being in new york heart association (nyha) class iv currently planned coronary, carotid or peripheral artery revascularisation
boolean
C1882087 (UMLS CUI [1])
C3203629 (UMLS CUI [2])
ketoacidosis; screening; diabetic; visit; last
Item
diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (visit 1)
boolean
C0011880 (UMLS CUI [1])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video