ID

17310

Descripción

Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00619697

Link

https://clinicaltrials.gov/show/NCT00619697

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 NCT00619697

Inglés

Eligibility Diabetes NCT00619697

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00619697
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes for at least 6 months
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. short term insulin treatment (7 days or less within the last 6 months) is allowed
Descripción

Insulin Therapy naive | Insulin, Short-Acting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
UMLS CUI [2]
C0356365
previous treatment with oral antidiabetic drugs for at least 4 months
Descripción

Oral hypoglycemic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0359086
judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
Descripción

Indication Insulin regime | Insulin Analogue | Oral hypoglycemic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0557978
UMLS CUI [2]
C2825028
UMLS CUI [3]
C0359086
bmi below 40 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
hba1c between 7-12%
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
able and willing to perform self-plasma glucose monitoring
Descripción

Plasma Glucose Measurement Self Monitoring Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0588436
UMLS CUI [1,3]
C0600109
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
the receipt of any other investigational drug within 4 weeks before screening
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
a history of drug or alcohol abuse within the last 12 months
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
severe, uncontrolled hypertension
Descripción

Uncontrolled hypertension Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
known or suspected allergy to trial products 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 NCT00619697

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00619697
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 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Therapy naive | Insulin, Short-Acting
Item
insulin naive. short term insulin treatment (7 days or less within the last 6 months) is allowed
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0356365 (UMLS CUI [2])
Oral hypoglycemic
Item
previous treatment with oral antidiabetic drugs for at least 4 months
boolean
C0359086 (UMLS CUI [1])
Indication Insulin regime | Insulin Analogue | Oral hypoglycemic
Item
judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
boolean
C3146298 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
C2825028 (UMLS CUI [2])
C0359086 (UMLS CUI [3])
Body mass index
Item
bmi below 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c between 7-12%
boolean
C0019018 (UMLS CUI [1])
Plasma Glucose Measurement Self Monitoring Willing
Item
able and willing to perform self-plasma glucose monitoring
boolean
C0202042 (UMLS CUI [1,1])
C0588436 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
the receipt of any other investigational drug within 4 weeks before screening
boolean
C0013230 (UMLS CUI [1])
Substance Use Disorders
Item
a history of drug or alcohol abuse within the last 12 months
boolean
C0038586 (UMLS CUI [1])
Uncontrolled hypertension Severe
Item
severe, uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs
Item
known or suspected allergy to trial products 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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