ID

34289

Description

A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT01713530

Lien

https://clinicaltrials.gov/show/NCT01713530

Mots-clés

Versions (1)
  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 NCT01713530

Anglais

Eligibility Diabetes NCT01713530

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01713530
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
Description

ID.1

Type de données

boolean

treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (su)/glinide, dpp-4 inhibitors, alfa-glucosidase-inhibitors
Description

ID.2

Type de données

boolean

hba1c 7.0% - 10.0%
Description

ID.3

Type de données

boolean

body mass index (bmi) less than or equal to 40.0 kg/m^2
Description

ID.4

Type de données

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
Description

ID.5

Type de données

boolean

stroke; heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Description

ID.6

Type de données

boolean

chronic disorder or disease which might jeopardise safety or compliance
Description

ID.7

Type de données

boolean

malignant neoplasms
Description

ID.8

Type de données

boolean

recurrent severe hypoglycaemia
Description

ID.9

Type de données

boolean

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Similar models

Eligibility Diabetes NCT01713530

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01713530
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
diagnosis of type 2 diabetes mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
boolean
ID.2
Item
treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (su)/glinide, dpp-4 inhibitors, alfa-glucosidase-inhibitors
boolean
ID.3
Item
hba1c 7.0% - 10.0%
boolean
ID.4
Item
body mass index (bmi) less than or equal to 40.0 kg/m^2
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
boolean
ID.6
Item
stroke; heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
boolean
ID.7
Item
chronic disorder or disease which might jeopardise safety or compliance
boolean
ID.8
Item
malignant neoplasms
boolean
ID.9
Item
recurrent severe hypoglycaemia
boolean
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