ID

39014

Description

Biphasic Insulin Aspart Versus NPH Plus Regular Human Insulin in Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01889095

Link

https://clinicaltrials.gov/show/NCT01889095

Keywords

  1. 11/20/19 11/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 20, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Type 2 NCT01889095

Eligibility Diabetes Type 2 NCT01889095

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetes type 2
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c 8% or higher
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
age 25 to 65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
alteration in insulin sensitivity such as major surgery, infection, renal failure (glomerular filtration rate < 50),
Description

Insulin Sensitivity altered | Major surgery | Communicable Disease | Kidney Failure | Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C0920563
UMLS CUI [1,2]
C0392747
UMLS CUI [2]
C0679637
UMLS CUI [3]
C0009450
UMLS CUI [4]
C0035078
UMLS CUI [5]
C0017654
glucocorticoid treatment,
Description

Glucocorticoid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0744425
recent (within 2 weeks) serious hypoglycemic episode (requires assistance of another),
Description

Hypoglycaemic episode Serious Recent | Assistance Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C1269765
UMLS CUI [2,2]
C1514873
simultaneous participating in another clinical study,
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
using any type of insulin,
Description

Insulin use

Data type

boolean

Alias
UMLS CUI [1]
C0240016
sight or hearing impaired,
Description

Visual Impairment | Hearing impairment

Data type

boolean

Alias
UMLS CUI [1]
C3665347
UMLS CUI [2]
C1384666
active proliferative retinopathy or maculopathy require treatment within 6 months prior to screening,
Description

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
breast feeding,
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
pregnancy or nursing of the intention of becoming pregnant or
Description

Pregnancy | Breast Feeding | Pregnancy intended

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
not using adequate contraceptive measures.
Description

Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332197

Similar models

Eligibility Diabetes Type 2 NCT01889095

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes type 2
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c 8% or higher
boolean
C0474680 (UMLS CUI [1])
Age
Item
age 25 to 65
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin Sensitivity altered | Major surgery | Communicable Disease | Kidney Failure | Glomerular Filtration Rate
Item
alteration in insulin sensitivity such as major surgery, infection, renal failure (glomerular filtration rate < 50),
boolean
C0920563 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C0035078 (UMLS CUI [4])
C0017654 (UMLS CUI [5])
Glucocorticoid therapy
Item
glucocorticoid treatment,
boolean
C0744425 (UMLS CUI [1])
Hypoglycaemic episode Serious Recent | Assistance Required
Item
recent (within 2 weeks) serious hypoglycemic episode (requires assistance of another),
boolean
C0745153 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C1269765 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Study Subject Participation Status
Item
simultaneous participating in another clinical study,
boolean
C2348568 (UMLS CUI [1])
Insulin use
Item
using any type of insulin,
boolean
C0240016 (UMLS CUI [1])
Visual Impairment | Hearing impairment
Item
sight or hearing impaired,
boolean
C3665347 (UMLS CUI [1])
C1384666 (UMLS CUI [2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
active proliferative retinopathy or maculopathy require treatment within 6 months prior to screening,
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Breast Feeding
Item
breast feeding,
boolean
C0006147 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy intended
Item
pregnancy or nursing of the intention of becoming pregnant or
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
Contraceptive methods Absent
Item
not using adequate contraceptive measures.
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])

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