ID

17303

Descripción

Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00604396

Link

https://clinicaltrials.gov/show/NCT00604396

Palabras clave

Versiones (1)
  1. 6/9/16 6/9/16 -
Subido en

6 de septiembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT00604396

Inglés

Eligibility Diabetes NCT00604396

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00604396
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes for at least 12 months since diagnosis
Descripción

Non-Insulin-Dependent Diabetes Mellitus disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
insulin naive subjects
Descripción

Insulin Therapy naive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
oad treatment for at least 4 months alone or combined with no more than two oads
Descripción

Oral hypoglycemic Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1265611
body mass index (bmi) below 35.0 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
hba1c between 7.5-10.0%
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
able and willing to use twice a day injections for the entire trial period
Descripción

Injection U/day Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1828121
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C0600109
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or previous treatment with thiazolidiones within the last 6 months
Descripción

Thiazolidinediones

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1257987
oad treatment with three or more oads within the last 6 months
Descripción

Oral hypoglycemic Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1265611
acute insulin treatment for longer than 7 days in a row within the last 6 months
Descripción

Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
secondary diabetes
Descripción

Secondary diabetes mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0271640
known maturity onset of diabetes of young (mody)
Descripción

Maturity onset diabetes mellitus in young

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342276
known or suspected allergy to trial product or related products
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0013230
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Similar models

Eligibility Diabetes NCT00604396

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00604396
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 2 diabetes for at least 12 months since diagnosis
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Therapy naive
Item
insulin naive subjects
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Oral hypoglycemic Quantity
Item
oad treatment for at least 4 months alone or combined with no more than two oads
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Body mass index
Item
body mass index (bmi) below 35.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c between 7.5-10.0%
boolean
C0019018 (UMLS CUI [1])
Injection U/day Willing
Item
able and willing to use twice a day injections for the entire trial period
boolean
C1828121 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones
Item
current or previous treatment with thiazolidiones within the last 6 months
boolean
C1257987 (UMLS CUI [1])
Oral hypoglycemic Quantity
Item
oad treatment with three or more oads within the last 6 months
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Insulin regime
Item
acute insulin treatment for longer than 7 days in a row within the last 6 months
boolean
C0557978 (UMLS CUI [1])
Secondary diabetes mellitus
Item
secondary diabetes
boolean
C0271640 (UMLS CUI [1])
Maturity onset diabetes mellitus in young
Item
known maturity onset of diabetes of young (mody)
boolean
C0342276 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Volver a la parte superior de la página 

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