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 receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks
Item
type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone 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)
C0071097 (UMLS CUI 2011AA)
395828009 (SNOMED CT 2011_0131)
C0289313 (UMLS CUI 2011AA)
395869000 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
HbA1c >=7.0% and <=10% at screening
Item
HbA1c >=7.0% and <=10% at screening
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening
Item
BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
C0078988 (UMLS CUI 2011AA)
413582008 (SNOMED CT 2011_0131)
2028-9 (HL7 V3 2006_05)
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
C0424657 (UMLS CUI 2011AA)
271398006 (SNOMED CT 2011_0131)
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)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
Item
history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
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)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0273163 (UMLS CUI 2011AA)
61823004 (SNOMED CT 2011_0131)
10033627 (MedDRA 14.1)
S36.2 (ICD-10-CM Version 2010)
C0271640 (UMLS CUI 2011AA)
8801005 (SNOMED CT 2011_0131)
249 (ICD-9-CM Version 2011)
history of acute metabolic diabetic complications within the previous 6 months
Item
history of acute metabolic diabetic complications within the previous 6 months
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
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)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
evidence of clinically significant diabetic complications
Item
evidence of clinically significant diabetic complications
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
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)
known proliferative diabetic retinopathy
Item
Proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI 2011AA)
59276001 (SNOMED CT 2011_0131)
10036857 (MedDRA 14.1)
362.02 (ICD-9-CM Version 2011)
myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months
Item
myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) 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)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator
Item
any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator
boolean
C1704258 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
known hemoglobinopathy or chronic anemia
Item
known hemoglobinopathy or chronic anemia
boolean
C0019045 (UMLS CUI 2011AA)
80141007 (SNOMED CT 2011_0131)
10060892 (MedDRA 14.1)
MTHU029621 (LOINC Version 232)
D58.2 (ICD-10-CM Version 2010)
C0581384 (UMLS CUI 2011AA)
191268006 (SNOMED CT 2011_0131)
D53.9 (ICD-10-CM Version 2010)
clinically significant gastrointestinal disease.
Item
clinically significant gastrointestinal disease.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
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