ID

43345

Description

ODM derived from http://clinicaltrials.gov/show/NCT00359762

Link

http://clinicaltrials.gov/show/NCT00359762

Keywords

Versions (3)
  1. 3/22/12 3/22/12 -
  2. 4/14/14 4/14/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00359762 Type 2 Diabetes Mellitus

German English

Eligibility

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

Inclusion Criteria

age 18 Years to 85 Years
Description

age 18 Years to 85 Years

Data type

boolean

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

Diagnosed with type 2 diabetes mellitus.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
Description

Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0012155
SNOMED CT 2011_0131
41829006
UMLS CUI 2011AA
C0015259
SNOMED CT 2011_0131
256235009
MedDRA 14.1
10015634
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
HbA1c >=6.5% and <=9.0%.
Description

HbA1c >=6.5% and <=9.0%.

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
Body Mass Index (BMI) >=25 kg/m2 and <40 kg/m2.
Description

Body Mass Index (BMI) >=25 kg/m2 and <40 kg/m2.

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

Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
Description

Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
Characteristics contraindicating metformin or glimepiride use.
Description

Characteristics contraindicating metformin or glimepiride use.

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0061323
SNOMED CT 2011_0131
386966003
LOINC Version 232
MTHU018302
Receiving drugs that directly affect gastrointestinal motility.
Description

Receiving drugs that directly affect gastrointestinal motility.

Data type

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0017184
Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
Description

Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
CL383594
Have used any prescription drug to promote weight loss within 3 months prior to screening.
Description

Have used any prescription drug to promote weight loss within 3 months prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1262477
SNOMED CT 2011_0131
89362005
MedDRA 14.1
10047895
LOINC Version 232
MTHU020881
ICD-9-CM Version 2011
783.21
CTCAE 1105E
E12228
Description

Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: insulin, thiazolidinediones, alpha-glucosidase inhibitors, sulfonylurea, meglitinides

Data type

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C1257987
SNOMED CT 2011_0131
109086001
UMLS CUI 2011AA
C2267008
UMLS CUI 2011AA
C0038766
UMLS CUI 2011AA
C1579432
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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 18 Years to 85 Years
Item
age 18 Years to 85 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosed with type 2 diabetes mellitus.
Item
Diagnosed with type 2 diabetes mellitus.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
Item
Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
boolean
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0013227 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
HbA1c >=6.5% and <=9.0%.
Item
HbA1c >=6.5% and <=9.0%.
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Body Mass Index (BMI) >=25 kg/m2 and <40 kg/m2.
Item
Body Mass Index (BMI) >=25 kg/m2 and <40 kg/m2.
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Item Group
Exclusion Criteria
Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
Item
Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
boolean
C2348568 (UMLS CUI 2011AA)
Characteristics contraindicating metformin or glimepiride use.
Item
Characteristics contraindicating metformin or glimepiride use.
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0061323 (UMLS CUI 2011AA)
386966003 (SNOMED CT 2011_0131)
MTHU018302 (LOINC Version 232)
Receiving drugs that directly affect gastrointestinal motility.
Item
Receiving drugs that directly affect gastrointestinal motility.
boolean
C0013227 (UMLS CUI 2011AA)
C0017184 (UMLS CUI 2011AA)
Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
Item
Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
CL383594 (UMLS CUI 2011AA)
Have used any prescription drug to promote weight loss within 3 months prior to screening.
Item
Have used any prescription drug to promote weight loss within 3 months prior to screening.
boolean
C0013227 (UMLS CUI 2011AA)
C1262477 (UMLS CUI 2011AA)
89362005 (SNOMED CT 2011_0131)
10047895 (MedDRA 14.1)
MTHU020881 (LOINC Version 232)
783.21 (ICD-9-CM Version 2011)
E12228 (CTCAE 1105E)
Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: insulin, thiazolidinediones, alpha-glucosidase inhibitors, sulfonylurea, meglitinides
Item
boolean
C0013227 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
C2267008 (UMLS CUI 2011AA)
C0038766 (UMLS CUI 2011AA)
C1579432 (UMLS CUI 2011AA)
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