ID

12953

Description

Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01467323

Link

https://clinicaltrials.gov/show/NCT01467323

Keywords

  1. 1/7/16 1/7/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 7, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Diabetes NCT01467323

Eligibility Diabetes NCT01467323

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01467323
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
Description

insulin requiring type 1 or type 2 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011849
current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
Description

insulin

Data type

boolean

Alias
UMLS CUI [1]
C0021641
body mass index (bmi) below or equal to 35.0 kg/m^2
Description

body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c below or equal to 11.0%
Description

hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
total daily insulin dose at least 1.4 iu/kg
Description

total daily insulin dose at least 1.4 iu/kg

Data type

boolean

Alias
UMLS CUI [1]
C0021641
treatment with oral hypoglycaemic agents within the month prior to inclusion
Description

oral hypoglycaemic agents

Data type

boolean

Alias
UMLS CUI [1]
C0359086
recurrent severe hypoglycaemia (as judged by the investigator)
Description

hypoglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0020615
active proliferative retinopathy
Description

proliferative retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0339467
impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
Description

impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)

Data type

boolean

Alias
UMLS CUI [1]
C0201976
history of pancreatitis
Description

pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305

Similar models

Eligibility Diabetes NCT01467323

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01467323
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
insulin requiring type 1 or type 2 diabetes
Item
subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
boolean
C0011849 (UMLS CUI [1])
insulin
Item
current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
boolean
C0021641 (UMLS CUI [1])
body mass index
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
hba1c
Item
hba1c below or equal to 11.0%
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
total daily insulin dose at least 1.4 iu/kg
Item
total daily insulin dose at least 1.4 iu/kg
boolean
C0021641 (UMLS CUI [1])
oral hypoglycaemic agents
Item
treatment with oral hypoglycaemic agents within the month prior to inclusion
boolean
C0359086 (UMLS CUI [1])
hypoglycemia
Item
recurrent severe hypoglycaemia (as judged by the investigator)
boolean
C0020615 (UMLS CUI [1])
proliferative retinopathy
Item
active proliferative retinopathy
boolean
C0339467 (UMLS CUI [1])
impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
Item
impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
boolean
C0201976 (UMLS CUI [1])
pancreatitis
Item
history of pancreatitis
boolean
C0030305 (UMLS CUI [1])

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