ID

16834

Descripción

Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00184613

Link

https://clinicaltrials.gov/show/NCT00184613

Palabras clave

Versiones (1)
  1. 9/8/16 9/8/16 -
Subido en

9 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT00184613

Inglés

Eligibility Diabetes NCT00184613

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00184613
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 diabetes for more than 2 years
Descripción

Type 2 diabetes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2 weeks
Descripción

insulin glargine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0907402
subjects currently treated with unchanged dose(s) for at least 1 month on one or two oral anti-diabetic drugs
Descripción

oral anti-diabetic drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0359086
bmi 25 - 40 kg/m2
Descripción

BMI

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
hba1c < 9.5 %
Descripción

HbA1C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to trial product(s) or related products
Descripción

allergy to trial product(s) or related products

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0907402
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0123677
previous randomisation in this trial
Descripción

previous randomisation in this trial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures (only sterilisation, intra uterine devices and contraceptive pills are considered adequate contraceptive methods)
Descripción

pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C2081645
UMLS CUI [4]
C0700589
mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation.
Descripción

mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
any other significant illness such as endocrine, cardiac, neurological, malignant or other pancreatic illness judged by investigator
Descripción

other significant illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
participation in other studies within the last three months
Descripción

participation in other studies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Diabetes NCT00184613

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00184613
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Type 2 diabetes
Item
subjects with type 2 diabetes for more than 2 years
boolean
C0011860 (UMLS CUI [1])
insulin glargine
Item
subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2 weeks
boolean
C0907402 (UMLS CUI [1])
oral anti-diabetic drugs
Item
subjects currently treated with unchanged dose(s) for at least 1 month on one or two oral anti-diabetic drugs
boolean
C0359086 (UMLS CUI [1])
BMI
Item
bmi 25 - 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
HbA1C
Item
hba1c < 9.5 %
boolean
C0202054 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
allergy to trial product(s) or related products
Item
known or suspected allergy to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0907402 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0123677 (UMLS CUI [2,2])
previous randomisation in this trial
Item
previous randomisation in this trial
boolean
C2348568 (UMLS CUI [1])
pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures
Item
pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures (only sterilisation, intra uterine devices and contraceptive pills are considered adequate contraceptive methods)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C2081645 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation
Item
mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
other significant illness
Item
any other significant illness such as endocrine, cardiac, neurological, malignant or other pancreatic illness judged by investigator
boolean
C0009488 (UMLS CUI [1])
participation in other studies
Item
participation in other studies within the last three months
boolean
C2348568 (UMLS CUI [1])
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