ID

5014

Description

ODM derived from http://clinicaltrials.gov/show/NCT00823992

Link

http://clinicaltrials.gov/show/NCT00823992

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
Uploaded on

April 16, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00823992 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 18 Years to 75 Years
Description

age 18 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Adult (person)
Description

adult patients, 18-75 years of age

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks
Description

type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks

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
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
HbA1c >=6.5% and <=9.5% at screening
Description

HbA1c >=6.5% and <=9.5% at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
BMI >=30 and <=50 kg/m2 at screening
Description

BMI >=30 and <=50 kg/m2 at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
UMLS CUI 2011AA
C1409616
stable weight +/-5% for at least 12 weeks prior to screening.
Description

stable weight +/-5% for at least 12 weeks prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
Description

history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
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
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0311400
UMLS CUI 2011AA
C0342257
SNOMED CT 2011_0131
74627003
MedDRA 14.1
10061104
ICD-9-CM Version 2011
250.9
UMLS CUI 2011AA
C0220982
SNOMED CT 2011_0131
56051008
MedDRA 14.1
10023379
UMLS CUI 2011AA
C0020457
SNOMED CT 2011_0131
190329007
MedDRA 14.1
10012669
evidence of clinically significant diabetic complications
Description

evidence of clinically significant diabetic complications

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0342257
SNOMED CT 2011_0131
74627003
MedDRA 14.1
10061104
ICD-9-CM Version 2011
250.9
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
Description

myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0010055
SNOMED CT 2011_0131
232717009
MedDRA 14.1
10011077
ICD-9-CM Version 2011
36.10
UMLS CUI 2011AA
CL411823
SNOMED CT 2011_0131
85898001
MedDRA 14.1
10007636
ICD-10-CM Version 2010
I42.9
ICD-9-CM Version 2011
425
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
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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 18 Years to 75 Years
Item
Age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
adult patients, 18-75 years of age
Item
Adult (person)
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks
Item
type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks
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)
C1514756 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (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)
HbA1c >=6.5% and <=9.5% at screening
Item
HbA1c >=6.5% and <=9.5% at screening
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
BMI >=30 and <=50 kg/m2 at screening
Item
BMI >=30 and <=50 kg/m2 at screening
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
C1409616 (UMLS CUI 2011AA)
stable weight +/-5% for at least 12 weeks prior to screening.
Item
stable weight +/-5% for at least 12 weeks prior to screening.
boolean
C0005910 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
Item
history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0311400 (UMLS CUI 2011AA)
C0342257 (UMLS CUI 2011AA)
74627003 (SNOMED CT 2011_0131)
10061104 (MedDRA 14.1)
250.9 (ICD-9-CM Version 2011)
C0220982 (UMLS CUI 2011AA)
56051008 (SNOMED CT 2011_0131)
10023379 (MedDRA 14.1)
C0020457 (UMLS CUI 2011AA)
190329007 (SNOMED CT 2011_0131)
10012669 (MedDRA 14.1)
evidence of clinically significant diabetic complications
Item
evidence of clinically significant diabetic complications
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0342257 (UMLS CUI 2011AA)
74627003 (SNOMED CT 2011_0131)
10061104 (MedDRA 14.1)
250.9 (ICD-9-CM Version 2011)
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
Item
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
boolean
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0010055 (UMLS CUI 2011AA)
232717009 (SNOMED CT 2011_0131)
10011077 (MedDRA 14.1)
36.10 (ICD-9-CM Version 2011)
CL411823 (UMLS CUI 2011AA)
85898001 (SNOMED CT 2011_0131)
10007636 (MedDRA 14.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
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