ID

23994

Description

Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00530309

Link

https://clinicaltrials.gov/show/NCT00530309

Keywords

Versions (1)
  1. 7/20/17 7/20/17 -
Uploaded on

July 20, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Type 2 Diabetes Mellitus NCT00530309

English

Eligibility Type 2 Diabetes Mellitus NCT00530309

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus diagnosed at least 3 months with fpg level <=240mg/dl and hba1c between 6.5% and 10% inclusive.
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0019018
must be diet controlled - or - taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study.
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1,1]
C0743195
UMLS CUI [1,2]
C0935929
must have a bmi:<=35kg/m2, 20 to 70 years of age inclusive.
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C1305855
woman must be of non-childbearing potential.
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive test result for either syphilis, hbs antigen, hcv antibody, hiv antigen/antibody, or htlv-1 antibody.
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1,1]
C0039128
UMLS CUI [1,2]
C0019168
UMLS CUI [1,3]
C0166049
UMLS CUI [1,4]
C0369498
UMLS CUI [1,5]
C0019683
UMLS CUI [1,6]
C0020095
clinically significant hepatic enzyme elevation.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C0235996
history of metabolic disease other than t2dm.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0025517
previous use of insulin as a treatment for diabetes within 3 months.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0557978
history of severe gastrointestinal disease.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0017178
clinically significant cardiovascular disease.
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C0007222
significant renal disease as defined by screening lab test.
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1]
C0022658
history of drug (including albumin or albumin containing agents) allergy.
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1]
C0013182
history of alcohol or drug abuse.
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0013146
donation of blood in excess of 400ml within previous 4 months.
Description

ID.14

Data type

boolean

Alias
UMLS CUI [1]
C0005794
previously received any glp-1 mimetic or any other albumin-containing products.
Description

ID.15

Data type

boolean

Alias
UMLS CUI [1,1]
C0061355
UMLS CUI [1,2]
C0001924
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00530309

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
type 2 diabetes mellitus diagnosed at least 3 months with fpg level <=240mg/dl and hba1c between 6.5% and 10% inclusive.
boolean
C0011860 (UMLS CUI [1,1])
C0019018 (UMLS CUI [1,2])
ID.2
Item
must be diet controlled - or - taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study.
boolean
C0743195 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
ID.3
Item
must have a bmi:<=35kg/m2, 20 to 70 years of age inclusive.
boolean
C1305855 (UMLS CUI [1])
ID.4
Item
woman must be of non-childbearing potential.
boolean
C0032961 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.5
Item
positive test result for either syphilis, hbs antigen, hcv antibody, hiv antigen/antibody, or htlv-1 antibody.
boolean
C0039128 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
C0166049 (UMLS CUI [1,3])
C0369498 (UMLS CUI [1,4])
C0019683 (UMLS CUI [1,5])
C0020095 (UMLS CUI [1,6])
ID.6
Item
clinically significant hepatic enzyme elevation.
boolean
C0235996 (UMLS CUI [1])
ID.7
Item
history of metabolic disease other than t2dm.
boolean
C0025517 (UMLS CUI [1])
ID.8
Item
previous use of insulin as a treatment for diabetes within 3 months.
boolean
C0557978 (UMLS CUI [1])
ID.9
Item
history of severe gastrointestinal disease.
boolean
C0017178 (UMLS CUI [1])
ID.10
Item
clinically significant cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
ID.11
Item
significant renal disease as defined by screening lab test.
boolean
C0022658 (UMLS CUI [1])
ID.12
Item
history of drug (including albumin or albumin containing agents) allergy.
boolean
C0013182 (UMLS CUI [1])
ID.13
Item
history of alcohol or drug abuse.
boolean
C0085762 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
ID.14
Item
donation of blood in excess of 400ml within previous 4 months.
boolean
C0005794 (UMLS CUI [1])
ID.15
Item
previously received any glp-1 mimetic or any other albumin-containing products.
boolean
C0061355 (UMLS CUI [1,1])
C0001924 (UMLS CUI [1,2])
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