ID

5056

Description

ODM derived from http://clinicaltrials.gov/show/NCT00968708

Link

http://clinicaltrials.gov/show/NCT00968708

Keywords

Versions (2)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
Uploaded on

April 17, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00968708 Diabetes Mellitus, Type 2

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosis of type 2 diabetes mellitus
Description

Diagnosis of type 2 diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
ICD-10-CM Version 2010
E08-E13
Subject is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the subject's antidiabetic regimen includes insulin)
Description

Subject is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the subject's antidiabetic regimen includes insulin)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0556895
SNOMED CT 2011_0131
229554006
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C1319284
SNOMED CT 2011_0131
408254005
UMLS CUI 2011AA
C1409616
Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization
Description

Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0948089
SNOMED CT 2011_0131
394659003
MedDRA 14.1
10051592
CTCAE 1105E
E10066
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Signs of type 1 diabetes mellitus
Description

Signs of type 1 diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011854
Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
Description

Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0061355
SNOMED CT 2011_0131
43004008
UMLS CUI 2011AA
C0243071
UMLS CUI 2011AA
C0005802
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C1409616
Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening
Description

Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1827106
SNOMED CT 2011_0131
423837000
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis of type 2 diabetes mellitus
Item
Diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI 2011AA)
E08-E13 (ICD-10-CM Version 2010)
Subject is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the subject's antidiabetic regimen includes insulin)
Item
Subject is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the subject's antidiabetic regimen includes insulin)
boolean
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C1319284 (UMLS CUI 2011AA)
408254005 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization
Item
Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0948089 (UMLS CUI 2011AA)
394659003 (SNOMED CT 2011_0131)
10051592 (MedDRA 14.1)
E10066 (CTCAE 1105E)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Signs of type 1 diabetes mellitus
Item
Signs of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI 2011AA)
Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
Item
Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
boolean
C1514756 (UMLS CUI 2011AA)
C0061355 (UMLS CUI 2011AA)
43004008 (SNOMED CT 2011_0131)
C0243071 (UMLS CUI 2011AA)
C0005802 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C1409616 (UMLS CUI 2011AA)
Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening
Item
Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening
boolean
C1514756 (UMLS CUI 2011AA)
C1827106 (UMLS CUI 2011AA)
423837000 (SNOMED CT 2011_0131)
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