Eligibility NCT00355849 Diabetes Mellitus, Type 2

ODM derived from http://clinicaltrials.gov/show/NCT00355849

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age >=18 Years
Item
age >=18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
type 2 diabetes mellitus
Item
Diabetes Mellitus, Non-Insulin-Dependent
boolean
C0011860 (UMLS CUI 2011AA)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
one or more oral antihyperglycemic medications
Item
one or more oral antihyperglycemic medications
boolean
C0013227 (UMLS CUI 1)
C0359086 (UMLS CUI 2)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
once-daily insulin glargine
Item
once-daily insulin glargine
boolean
C0907402 (UMLS CUI 1)
411529005 (SNOMED CT 1)
C0556983 (UMLS CUI 3)
229797004 (SNOMED CT 2)
HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
Item
HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Non-smoker
Item
Non-smoker
boolean
C0337672 (UMLS CUI 2011AA)
8392000 (SNOMED CT 2011_0131)
10029560 (MedDRA 14.1)
Item Group
Exclusion Criteria
taking a TZD dose greater than what is indicated
Item
taking a TZD dose greater than what is indicated
boolean
C1257987 (UMLS CUI 1)
109086001 (SNOMED CT 1)
C0178602 (UMLS CUI 2)
260911001 (SNOMED CT 2)
more than two episodes of severe hypoglycemia during the 6 months prior
Item
more than two episodes of severe hypoglycemia during the 6 months prior
boolean
C0020615 (UMLS CUI 1)
302866003 (SNOMED CT 1)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C0205082 (UMLS CUI 2)
24484000 (SNOMED CT 2011_0131)
C0332189 (UMLS CUI 3)
272128006 (SNOMED CT 3)
Have had a lower respiratory infection in the 3 months prior
Item
Have had a lower respiratory infection in the 3 months prior
boolean
C0149725 (UMLS CUI 2011AA)
50417007 (SNOMED CT 2011_0131)
10024968 (MedDRA 14.1)
systemic glucocorticoid therapy
Item
systemic Steroid Therapy
boolean
CL383594 (UMLS CUI 2011AA)
clinical signs or symptoms of liver disease, acute or chronic hepatitis
Item
clinical signs or symptoms of liver disease, acute or chronic hepatitis
boolean
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
history of renal transplantation
Item
history of renal transplantation
boolean
C0262926 (UMLS CUI 1)
417662000 (SNOMED CT 1)
MTHU027722 (LOINC Version 232)
C0022671 (UMLS CUI 2)
70536003 (SNOMED CT 2)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
Have an active or untreated malignancy
Item
active or untreated malignancy
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Require more than 150 U/day of insulin glargine
Item
Require more than 150 U/day of insulin glargine
boolean
C0907402 (UMLS CUI 1)
411529005 (SNOMED CT 1)
C0178602 (UMLS CUI 2)
260911001 (SNOMED CT 2)

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