ID

34290

Beschreibung

Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01831765

Link

https://clinicaltrials.gov/show/NCT01831765

Stichworte

  1. 16.01.19 16.01.19 -
Rechteinhaber

see on clinicaltrials.gov

Hochgeladen am

16. Januar 2019

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Diabetes NCT01831765

Eligibility Diabetes NCT01831765

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01831765
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (visit 1)
Beschreibung

ID.1

Datentyp

boolean

currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (visit 1)
Beschreibung

ID.2

Datentyp

boolean

currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (visit 1)
Beschreibung

ID.3

Datentyp

boolean

hba1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
Beschreibung

ID.4

Datentyp

boolean

body mass index (bmi) below or equal to 35.0 kg/m^2
Beschreibung

ID.5

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (visit 1)
Beschreibung

ID.6

Datentyp

boolean

recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1)
Beschreibung

ID.7

Datentyp

boolean

cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as stroke, decompensated heart failure new york heart association (nyha) class iii or iv, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty
Beschreibung

ID.8

Datentyp

boolean

Ähnliche Modelle

Eligibility Diabetes NCT01831765

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01831765
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (visit 1)
boolean
ID.2
Item
currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (visit 1)
boolean
ID.3
Item
currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (visit 1)
boolean
ID.4
Item
hba1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
boolean
ID.5
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
Item Group
C0680251 (UMLS CUI)
ID.6
Item
use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (visit 1)
boolean
ID.7
Item
recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1)
boolean
ID.8
Item
cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as stroke, decompensated heart failure new york heart association (nyha) class iii or iv, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty
boolean

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