ID

15277

Description

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

Keywords

  1. 5/24/16 5/24/16 -
Uploaded on

May 24, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes NCT01620424

Eligibility Diabetes NCT01620424

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

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Description

type 2 diabetes

Data type

boolean

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

duration of diabetes

Data type

boolean

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

BMI

Data type

boolean

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

hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
recurrent severe hypoglycaemia
Description

hypoglycaemia

Data type

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
Description

retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0035309
impaired hepatic function
Description

impaired hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
impaired renal function
Description

impaired renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
cardiac problems
Description

cardiac problems

Data type

boolean

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

hypertension

Data type

boolean

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

hepatitis antigens

Data type

boolean

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

insulin dose

Data type

boolean

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

ohas

Data type

boolean

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

ohas or insulin preparations

Data type

boolean

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

smoking

Data type

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)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial