ID

34289

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01713530

Trefwoorden

  1. 16-01-19 16-01-19 -
Houder van rechten

see on clinicaltrials.gov

Geüploaded op

16 januari 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes NCT01713530

Eligibility Diabetes NCT01713530

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01713530
Inclusion Criteria
Beschrijving

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)
Beschrijving

ID.1

Datatype

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
Beschrijving

ID.2

Datatype

boolean

hba1c 7.0% - 10.0%
Beschrijving

ID.3

Datatype

boolean

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

ID.4

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

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

ID.5

Datatype

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
Beschrijving

ID.6

Datatype

boolean

chronic disorder or disease which might jeopardise safety or compliance
Beschrijving

ID.7

Datatype

boolean

malignant neoplasms
Beschrijving

ID.8

Datatype

boolean

recurrent severe hypoglycaemia
Beschrijving

ID.9

Datatype

boolean

Similar models

Eligibility Diabetes NCT01713530

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01713530
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial