ID

34290

Description

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

Lien

https://clinicaltrials.gov/show/NCT01831765

Mots-clés

  1. 16/01/2019 16/01/2019 -
Détendeur de droits

see on clinicaltrials.gov

Téléchargé le

16 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

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Eligibility Diabetes NCT01831765

Eligibility Diabetes NCT01831765

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

Inclusion Criteria

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

ID.1

Type de données

boolean

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

ID.2

Type de données

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)
Description

ID.3

Type de données

boolean

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

ID.4

Type de données

boolean

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

ID.5

Type de données

boolean

Exclusion Criteria
Description

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)
Description

ID.6

Type de données

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)
Description

ID.7

Type de données

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
Description

ID.8

Type de données

boolean

Similar models

Eligibility Diabetes NCT01831765

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01831765
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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