ID

5083

Description

ODM derived from http://clinicaltrials.gov/show/NCT01107886

Link

http://clinicaltrials.gov/show/NCT01107886

Keywords

Versions (2)
  1. 12/6/13 12/6/13 - 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 NCT01107886 Type 2 Diabetes Mellitus

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 40 Years
Description

age at least 40 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with type 2 diabetes mellitus
Description

Patients with type 2 diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
HbA1c >=6.5%. (based on the last measured and documented laboratory measurement within 6 months)
Description

HbA1c >=6.5%. (based on the last measured and documented laboratory measurement within 6 months)

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C1705938
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0681902
High risk for CV events -Established cardiovascular disease and/or multiple risk factors
Description

High risk for CV events -Established cardiovascular disease and/or multiple risk factors

Data type

boolean

Alias
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C1320716
SNOMED CT 2011_0131
405617006
UMLS CUI 2011AA
C0443211
SNOMED CT 2011_0131
263748003
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0439064
SNOMED CT 2011_0131
255204007
UMLS CUI 2011AA
C0035648
SNOMED CT 2011_0131
80943009
LOINC Version 232
MTHU028018
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
Description

Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1827106
SNOMED CT 2011_0131
423837000
UMLS CUI 2011AA
CL430618
Acute vascular event <2months prior to randomisation
Description

Acute vascular event <2months prior to randomisation

Data type

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C1801960
UMLS CUI 2011AA
C0441471
SNOMED CT 2011_0131
272379006
LOINC Version 232
MTHU019184
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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 40 Years
Item
age at least 40 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with type 2 diabetes mellitus
Item
Patients with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI 2011AA)
HbA1c >=6.5%. (based on the last measured and documented laboratory measurement within 6 months)
Item
HbA1c >=6.5%. (based on the last measured and documented laboratory measurement within 6 months)
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C1705938 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0681902 (UMLS CUI 2011AA)
High risk for CV events -Established cardiovascular disease and/or multiple risk factors
Item
High risk for CV events -Established cardiovascular disease and/or multiple risk factors
boolean
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C1320716 (UMLS CUI 2011AA)
405617006 (SNOMED CT 2011_0131)
C0443211 (UMLS CUI 2011AA)
263748003 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0035648 (UMLS CUI 2011AA)
80943009 (SNOMED CT 2011_0131)
MTHU028018 (LOINC Version 232)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
Item
Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
boolean
C0039798 (UMLS CUI 2011AA)
C1827106 (UMLS CUI 2011AA)
423837000 (SNOMED CT 2011_0131)
CL430618 (UMLS CUI 2011AA)
Acute vascular event <2months prior to randomisation
Item
Acute vascular event <2months prior to randomisation
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C1801960 (UMLS CUI 2011AA)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
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