ID

34289

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01713530

Nyckelord

  1. 2019-01-16 2019-01-16 -
Rättsinnehavare

see on clinicaltrials.gov

Uppladdad den

16 januari 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Diabetes NCT01713530

Eligibility Diabetes NCT01713530

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

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)
Beskrivning

ID.1

Datatyp

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
Beskrivning

ID.2

Datatyp

boolean

hba1c 7.0% - 10.0%
Beskrivning

ID.3

Datatyp

boolean

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

ID.4

Datatyp

boolean

Exclusion Criteria
Beskrivning

Exclusion Criteria

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

ID.5

Datatyp

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
Beskrivning

ID.6

Datatyp

boolean

chronic disorder or disease which might jeopardise safety or compliance
Beskrivning

ID.7

Datatyp

boolean

malignant neoplasms
Beskrivning

ID.8

Datatyp

boolean

recurrent severe hypoglycaemia
Beskrivning

ID.9

Datatyp

boolean

Similar models

Eligibility Diabetes NCT01713530

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