ID

17301

Description

Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00600366

Link

https://clinicaltrials.gov/show/NCT00600366

Keywords

Versions (1)
  1. 9/5/16 9/5/16 -
Uploaded on

September 5, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00600366

English

Eligibility Diabetes NCT00600366

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00600366
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
insulin naive diabetes
Description

Insulin Therapy naive Diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
UMLS CUI [1,3]
C0011847
current treatment with oha, secondary failure
Description

Oral hypoglycemic Therapeutic procedure failed secondary

Data type

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0231175
UMLS CUI [1,4]
C0205436
body mass index (bmi) below 40 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c over 8.5%
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
willing and able to start with insulin therapy and to perform self-blood glucose monitoring
Description

Insulin regime Willing | Blood Glucose Self-Monitoring Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0005803
UMLS CUI [2,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of drug or alcohol abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
receipt of the investigational drug within the last month prior to this trial
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
known or suspected allergy to trial products or related products
Description

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

Data type

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
severe uncontrolled hypertension
Description

Uncontrolled hypertension Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
any disease or condition, which the investigator feels, would interfere with the trial
Description

Disease Interferes with Clinical Trial | Condition Interferes with Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
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Similar models

Eligibility Diabetes NCT00600366

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00600366
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Insulin Therapy naive Diabetes
Item
insulin naive diabetes
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0011847 (UMLS CUI [1,3])
Oral hypoglycemic Therapeutic procedure failed secondary
Item
current treatment with oha, secondary failure
boolean
C0359086 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0205436 (UMLS CUI [1,4])
Body mass index
Item
body mass index (bmi) below 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c over 8.5%
boolean
C0019018 (UMLS CUI [1])
Insulin regime Willing | Blood Glucose Self-Monitoring Willing
Item
willing and able to start with insulin therapy and to perform self-blood glucose monitoring
boolean
C0557978 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Investigational New Drugs
Item
receipt of the investigational drug within the last month prior to this trial
boolean
C0013230 (UMLS CUI [1])
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])
Uncontrolled hypertension Severe
Item
severe uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Disease Interferes with Clinical Trial | Condition Interferes with Clinical Trial
Item
any disease or condition, which the investigator feels, would interfere with the trial
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
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