ID

44608

Description

ODM derived from http://clinicaltrials.gov/show/NCT01043029

Link

http://clinicaltrials.gov/show/NCT01043029

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - 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 NCT01043029 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
Adult (person)
Description

Adult patients >/= 18 years of age

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
Diabetes mellitus, Type 2
Description

Diabetes mellitus, Type 2

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
Moderately impaired kidney function
Description

Moderately impaired kidney function

Data type

boolean

Alias
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening
Description

Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0020616
SNOMED CT 2011_0131
312064005
LOINC Version 232
MTHU016642
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
C1409616
Body mass index
Description

BMI 25-35

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Current or previous treatment with a thiazolidinedione
Description

Current or previous treatment with a thiazolidinedione

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1257987
SNOMED CT 2011_0131
109086001
Current or previous treatment with insulin
Description

Current or previous treatment with insulin

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
Treatment with fibrates <3 months prior to screening
Description

Treatment with fibrates <3 months prior to screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1449704
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
History of renal disease other than diabetic nephropathy
Description

History of renal disease other than diabetic nephropathy

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0011881
SNOMED CT 2011_0131
127013003
MedDRA 14.1
10061835
ICD-9-CM Version 2011
250.4
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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)
Adult patients >/= 18 years of age
Item
Adult (person)
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
Diabetes mellitus, Type 2
Item
Diabetes mellitus, Type 2
boolean
C0011860 (UMLS CUI 2011AA)
Moderately impaired kidney function
Item
Moderately impaired kidney function
boolean
C1881878 (UMLS CUI 2011AA)
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening
Item
Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening
boolean
C0020616 (UMLS CUI 2011AA)
312064005 (SNOMED CT 2011_0131)
MTHU016642 (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)
C1409616 (UMLS CUI 2011AA)
BMI 25-35
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Current or previous treatment with a thiazolidinedione
Item
Current or previous treatment with a thiazolidinedione
boolean
C0039798 (UMLS CUI 2011AA)
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
Current or previous treatment with insulin
Item
Current or previous treatment with insulin
boolean
C0039798 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
Treatment with fibrates <3 months prior to screening
Item
Treatment with fibrates <3 months prior to screening
boolean
C0039798 (UMLS CUI 2011AA)
C1449704 (UMLS CUI 2011AA)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
History of renal disease other than diabetic nephropathy
Item
History of renal disease other than diabetic nephropathy
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0011881 (UMLS CUI 2011AA)
127013003 (SNOMED CT 2011_0131)
10061835 (MedDRA 14.1)
250.4 (ICD-9-CM Version 2011)
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