ID

15277

Beschrijving

Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01620424

Link

https://clinicaltrials.gov/show/NCT01620424

Trefwoorden

  1. 24-05-16 24-05-16 -
Geüploaded op

24 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Diabetes NCT01620424

Eligibility Diabetes NCT01620424

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01620424
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Beschrijving

type 2 diabetes

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
duration of diabetes for at least 1 year
Beschrijving

duration of diabetes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0872146
UMLS CUI [1,2]
C0011860
body mass index (bmi) maximum 30.0 kg/m^2
Beschrijving

BMI

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
hba1c maximum 10.0%
Beschrijving

hba1c

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
recurrent severe hypoglycaemia
Beschrijving

hypoglycaemia

Datatype

boolean

Alias
UMLS CUI [1]
C0020615
proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks
Beschrijving

retinopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0035309
impaired hepatic function
Beschrijving

impaired hepatic function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
impaired renal function
Beschrijving

impaired renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
cardiac problems
Beschrijving

cardiac problems

Datatype

boolean

Alias
UMLS CUI [1]
C0262402
uncontrolled treated / untreated hypertension
Beschrijving

hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0020538
hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive
Beschrijving

hepatitis antigens

Datatype

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0166049
UMLS CUI [3]
C0019686
total daily insulin dose exceeding 40 iu
Beschrijving

insulin dose

Datatype

boolean

Alias
UMLS CUI [1]
C0021641
treatment with ohas (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day
Beschrijving

ohas

Datatype

boolean

Alias
UMLS CUI [1]
C0359086
treatment with ohas or insulin preparations once a day later than noon
Beschrijving

ohas or insulin preparations

Datatype

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C0021641
subjects who smoke more than 15 cigarettes per day
Beschrijving

smoking

Datatype

boolean

Alias
UMLS CUI [1]
C0543414

Similar models

Eligibility Diabetes NCT01620424

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01620424
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
type 2 diabetes
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
duration of diabetes
Item
duration of diabetes for at least 1 year
boolean
C0872146 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
BMI
Item
body mass index (bmi) maximum 30.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
hba1c
Item
hba1c maximum 10.0%
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hypoglycaemia
Item
recurrent severe hypoglycaemia
boolean
C0020615 (UMLS CUI [1])
retinopathy
Item
proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks
boolean
C0035309 (UMLS CUI [1])
impaired hepatic function
Item
impaired hepatic function
boolean
C0232741 (UMLS CUI [1])
impaired renal function
Item
impaired renal function
boolean
C0232804 (UMLS CUI [1])
cardiac problems
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
hypertension
Item
uncontrolled treated / untreated hypertension
boolean
C0020538 (UMLS CUI [1])
hepatitis antigens
Item
hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive
boolean
C0019168 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0019686 (UMLS CUI [3])
insulin dose
Item
total daily insulin dose exceeding 40 iu
boolean
C0021641 (UMLS CUI [1])
ohas
Item
treatment with ohas (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day
boolean
C0359086 (UMLS CUI [1])
ohas or insulin preparations
Item
treatment with ohas or insulin preparations once a day later than noon
boolean
C0359086 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
smoking
Item
subjects who smoke more than 15 cigarettes per day
boolean
C0543414 (UMLS CUI [1])

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