ID

3711

Description

ODM derived from http://clinicaltrials.gov/show/NCT01243424

Link

http://clinicaltrials.gov/show/NCT01243424

Keywords

Versions (2)
  1. 2/22/13 2/22/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
Uploaded on

February 22, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01243424 Diabetes Mellitus, Type 2

German English

Eligibility

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

Inclusion Criteria

age 40 Years to 85 Years
Description

age 40 Years to 85 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Type 2 diabetes
Description

Type 2 diabetes

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Elevated glycosylated heamoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)
Description

Elevated glycosylated heamoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)

Data type

boolean

Alias
UMLS CUI 2011AA
CL414623
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C0919936
MedDRA 14.1
10051259
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C2267008
UMLS CUI 2011AA
C2316111
SNOMED CT 2011_0131
432955007
UMLS CUI 2011AA
C2266929
Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor
Description

Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor

Data type

boolean

Alias
UMLS CUI 2011AA
C2347662
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C0444930
SNOMED CT 2011_0131
261782000
UMLS CUI 2011AA
C0178784
LOINC Version 232
MTHU020170
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
CL025435
Exclusion Criteria
Description

Exclusion Criteria

Diabetes Mellitus, Insulin-Dependent
Description

Type 1 diabetes

Data type

boolean

Alias
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)
Description

Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
C0289313
SNOMED CT 2011_0131
395869000
UMLS CUI 2011AA
C0071097
SNOMED CT 2011_0131
395828009
UMLS CUI 2011AA
CL430618
UMLS CUI 2011AA
C2916791
UMLS CUI 2011AA
C1827106
SNOMED CT 2011_0131
423837000
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
Description

Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information

Data type

boolean

Alias
UMLS CUI 2011AA
C1548788
UMLS CUI 2011AA
C0061323
SNOMED CT 2011_0131
386966003
LOINC Version 232
MTHU018302
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0022646
SNOMED CT 2011_0131
64033007
LOINC Version 232
MTHU002935
UMLS CUI 2011AA
C2911688
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
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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
age 40 Years to 85 Years
Item
age 40 Years to 85 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Type 2 diabetes
Item
Type 2 diabetes
boolean
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Elevated glycosylated heamoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)
Item
Elevated glycosylated heamoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)
boolean
CL414623 (UMLS CUI 2011AA)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0919936 (UMLS CUI 2011AA)
10051259 (MedDRA 14.1)
C0039798 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C2267008 (UMLS CUI 2011AA)
C2316111 (UMLS CUI 2011AA)
432955007 (SNOMED CT 2011_0131)
C2266929 (UMLS CUI 2011AA)
Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor
Item
Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor
boolean
C2347662 (UMLS CUI 2011AA)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0444930 (UMLS CUI 2011AA)
261782000 (SNOMED CT 2011_0131)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
CL025435 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Type 1 diabetes
Item
Diabetes Mellitus, Insulin-Dependent
boolean
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)
Item
Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)
boolean
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C0289313 (UMLS CUI 2011AA)
395869000 (SNOMED CT 2011_0131)
C0071097 (UMLS CUI 2011AA)
395828009 (SNOMED CT 2011_0131)
CL430618 (UMLS CUI 2011AA)
C2916791 (UMLS CUI 2011AA)
C1827106 (UMLS CUI 2011AA)
423837000 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
Item
Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
boolean
C1548788 (UMLS CUI 2011AA)
C0061323 (UMLS CUI 2011AA)
386966003 (SNOMED CT 2011_0131)
MTHU018302 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
C2911688 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
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