ID

44643

Description

ODM derived from http://clinicaltrials.gov/show/NCT01144338

Link

http://clinicaltrials.gov/show/NCT01144338

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01144338 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 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patient has type 2 diabetes mellitus
Description

Patient has type 2 diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
Patient has an HbA1c of >= 7.0 % and <= 10.0% on stable doses of up to three oral antihyperglycemic agents for at least 3 months (i.e. no oral antihyperglycemic agent adjustments in the past 3 months)
Description

Patient has an HbA1c of >= 7.0 % and <= 10.0% on stable doses of up to three oral antihyperglycemic agents for at least 3 months (i.e. no oral antihyperglycemic agent adjustments in the past 3 months)

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0359086
SNOMED CT 2011_0131
346597008
LOINC Version 232
MTHU003326
Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
Description

Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C2826207
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
Description

Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0220982
SNOMED CT 2011_0131
56051008
MedDRA 14.1
10023379
Patient has taken insulin within 2 weeks of screening visit or for > 1 week within 3 months of screening visit.
Description

Patient has taken insulin within 2 weeks of screening visit or for > 1 week within 3 months of screening visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), Exenatide Once Weekly, VICTOZA (liraglutide), or taspoglutide.
Description

Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), Exenatide Once Weekly, VICTOZA (liraglutide), or taspoglutide.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332293
SNOMED CT 2011_0131
28995006
UMLS CUI 2011AA
C2917359
UMLS CUI 2011AA
C0167117
SNOMED CT 2011_0131
416859008
UMLS CUI 2011AA
C0558293
SNOMED CT 2011_0131
225769003
UMLS CUI 2011AA
C1456408
SNOMED CT 2011_0131
444907006
UMLS CUI 2011AA
C2716826
Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
Description

Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.

Data type

boolean

Alias
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0681814
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C1948041
SNOMED CT 2011_0131
71388002
MedDRA 14.1
10042613
LOINC Version 232
MTHU006237
ICD-9-CM Version 2011
00-99.99
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0681872
Patient has a planned or anticipated revascularization procedure.
Description

Patient has a planned or anticipated revascularization procedure.

Data type

boolean

Alias
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0679106
UMLS CUI 2011AA
C0581603
SNOMED CT 2011_0131
297183000
Pregnancy or planned pregnancy during the trial period.
Description

Pregnancy or planned pregnancy during the trial period.

Data type

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
Patient has previously been enrolled in EXenatide Study of Cardiovascular Event Lowering (EXSCEL).
Description

Patient has previously been enrolled in EXenatide Study of Cardiovascular Event Lowering (EXSCEL).

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0167117
SNOMED CT 2011_0131
416859008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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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)
Patient has type 2 diabetes mellitus
Item
Patient has type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI 2011AA)
Patient has an HbA1c of >= 7.0 % and <= 10.0% on stable doses of up to three oral antihyperglycemic agents for at least 3 months (i.e. no oral antihyperglycemic agent adjustments in the past 3 months)
Item
Patient has an HbA1c of >= 7.0 % and <= 10.0% on stable doses of up to three oral antihyperglycemic agents for at least 3 months (i.e. no oral antihyperglycemic agent adjustments in the past 3 months)
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0359086 (UMLS CUI 2011AA)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
Item
Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C2826207 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
Item
Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0220982 (UMLS CUI 2011AA)
56051008 (SNOMED CT 2011_0131)
10023379 (MedDRA 14.1)
Patient has taken insulin within 2 weeks of screening visit or for > 1 week within 3 months of screening visit.
Item
Patient has taken insulin within 2 weeks of screening visit or for > 1 week within 3 months of screening visit.
boolean
C1512806 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), Exenatide Once Weekly, VICTOZA (liraglutide), or taspoglutide.
Item
Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), Exenatide Once Weekly, VICTOZA (liraglutide), or taspoglutide.
boolean
C0332293 (UMLS CUI 2011AA)
28995006 (SNOMED CT 2011_0131)
C2917359 (UMLS CUI 2011AA)
C0167117 (UMLS CUI 2011AA)
416859008 (SNOMED CT 2011_0131)
C0558293 (UMLS CUI 2011AA)
225769003 (SNOMED CT 2011_0131)
C1456408 (UMLS CUI 2011AA)
444907006 (SNOMED CT 2011_0131)
C2716826 (UMLS CUI 2011AA)
Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
Item
Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
boolean
C1516879 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0681814 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C1948041 (UMLS CUI 2011AA)
71388002 (SNOMED CT 2011_0131)
10042613 (MedDRA 14.1)
MTHU006237 (LOINC Version 232)
00-99.99 (ICD-9-CM Version 2011)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0681872 (UMLS CUI 2011AA)
Patient has a planned or anticipated revascularization procedure.
Item
Patient has a planned or anticipated revascularization procedure.
boolean
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0679106 (UMLS CUI 2011AA)
C0581603 (UMLS CUI 2011AA)
297183000 (SNOMED CT 2011_0131)
Pregnancy or planned pregnancy during the trial period.
Item
Pregnancy or planned pregnancy during the trial period.
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
Patient has previously been enrolled in EXenatide Study of Cardiovascular Event Lowering (EXSCEL).
Item
Patient has previously been enrolled in EXenatide Study of Cardiovascular Event Lowering (EXSCEL).
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0167117 (UMLS CUI 2011AA)
416859008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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