ID
5086
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT01126580
Link
http://clinicaltrials.gov/show/NCT01126580
Palabras clave
Versiones (3)
- 6/12/13 6/12/13 - Martin Dugas
- 17/4/14 17/4/14 - Julian Varghese
- 27/9/21 27/9/21 -
Subido en
17 de abril de 2014
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT01126580 Diabetes Mellitus, Type 2
Eligibility
- StudyEvent: Eligibility
Descripción
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
You have type 1 diabetes mellitus
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0011854
- SNOMED CT 2011_0131
- 46635009
- MedDRA 14.1
- 10067584
- LOINC Version 232
- MTHU020217
- ICD-10-CM Version 2010
- E10
Descripción
You are being or have been treated with any of the following medications:
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- CL407060
- UMLS CUI 2011AA
- C0332282
- SNOMED CT 2011_0131
- 255260001
- UMLS CUI 2011AA
- C0013227
Descripción
a)chronically treated with insulin for the treatment of diabetes in the past, however, a short-term use of > 3 months prior to screening is allowable,
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0021641
- SNOMED CT 2011_0131
- 67866001
- LOINC Version 232
- MTHU019392
- UMLS CUI 2011AA
- CL433252
Descripción
b)GLP-1 analogs within 3 months prior to this screening,
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL430618
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Descripción
c)drugs to cause weight loss within 3 months prior to screening,
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0678227
- SNOMED CT 2011_0131
- 23981006
- UMLS CUI 2011AA
- C0043096
- SNOMED CT 2011_0131
- 89362005
- MedDRA 14.1
- 10047895
- LOINC Version 232
- MTHU020881
- ICD-9-CM Version 2011
- 783.21
- CTCAE 1105E
- E12228
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Descripción
d)thiazolidinediones (TZDs)within 3 months prior to screening,
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1257987
- SNOMED CT 2011_0131
- 109086001
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Descripción
e)chronically treated(>= 14 days) an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening,or
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C1527415
- SNOMED CT 2011_0131
- 26643006
- HL7 V3 2006_05
- _OralRoute
- UMLS CUI 2011AA
- C0017710
- SNOMED CT 2011_0131
- 419933005
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Descripción
f)illegal drugs.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0086190
- SNOMED CT 2011_0131
- 77657003
- LOINC Version 232
- MTHU035698
Descripción
You have had 1 or more cases of uncontrolled diabetes which required hospitalization in the 6 months prior to screening,
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0860161
- MedDRA 14.1
- 10012619
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0019993
- SNOMED CT 2011_0131
- 394656005
- MedDRA 14.1
- 10054112
Descripción
You have a problem with your stomach or have chronically taken medication to increase movement in your digestive tract or slow down the emptying of your digestive tract or you have had gastric bypass (bariatric) surgery.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0577027
- SNOMED CT 2011_0131
- 300306001
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C1512806
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0232459
- SNOMED CT 2011_0131
- 61578001
- MedDRA 14.1
- 10012980
- LOINC Version 232
- MTHU013235
- UMLS CUI 2011AA
- C0017125
- SNOMED CT 2011_0131
- 442338001
- MedDRA 14.1
- 10061966
- UMLS CUI 2011AA
- C0038895
- UMLS CUI 2011AA
- C1456587
- MedDRA 14.1
- 10068900
Descripción
You have had problems with your heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion,a heart rhythm problem, or a stroke.
Tipo de datos
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
- C0008031
- SNOMED CT 2011_0131
- 29857009
- MedDRA 14.1
- 10008479
- LOINC Version 232
- MTHU035552
- ICD-10-CM Version 2010
- R07.9
- ICD-9-CM Version 2011
- 786.5
- UMLS CUI 2011AA
- C0018801
- SNOMED CT 2011_0131
- 155374007
- MedDRA 14.1
- 10019279
- ICD-9-CM Version 2011
- 428
- CTCAE 1105E
- E10124
- UMLS CUI 2011AA
- C0010055
- SNOMED CT 2011_0131
- 232717009
- MedDRA 14.1
- 10011077
- ICD-9-CM Version 2011
- 36.10
- UMLS CUI 2011AA
- C0190211
- SNOMED CT 2011_0131
- 41339005
- MedDRA 14.1
- 10050329
- UMLS CUI 2011AA
- C0521232
- SNOMED CT 2011_0131
- 36969009
- MedDRA 14.1
- 10052086
- ICD-9-CM Version 2011
- 36.06
- UMLS CUI 2011AA
- C0003811
- SNOMED CT 2011_0131
- 44808001
- MedDRA 14.1
- 10003119
- ICD-9-CM Version 2011
- 427.9
- UMLS CUI 2011AA
- C0038454
- SNOMED CT 2011_0131
- 230690007
- MedDRA 14.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE 1105E
- E12826
Descripción
You have a serum creatinine result which shows a >= 1.5 mg/dL for men or >= 1.4 mg/dL for women.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
- UMLS CUI 2011AA
- C1274040
- SNOMED CT 2011_0131
- 79409006
- UMLS CUI 2011AA
- C0025266
- SNOMED CT 2011_0131
- 339947000
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
Descripción
You have a problem with your liver or pancreas.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0023895
- SNOMED CT 2011_0131
- 235856003
- MedDRA 14.1
- 10024670
- ICD-10-CM Version 2010
- K76.9
- ICD-9-CM Version 2011
- 573.9
- UMLS CUI 2011AA
- C0030286
- SNOMED CT 2011_0131
- 3855007
- MedDRA 14.1
- 10033616
- ICD-10-CM Version 2010
- K86.9
- ICD-9-CM Version 2011
- 577.9
Descripción
You have creatinine clearance result which shows < 60 mL/minute, evidence of a significant active, uncontrolled endocrine (hormone) or active autoimmune abnormality.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
- UMLS CUI 2011AA
- C1274040
- SNOMED CT 2011_0131
- 79409006
- UMLS CUI 2011AA
- C0332120
- SNOMED CT 2011_0131
- 18669006
- UMLS CUI 2011AA
- C0014130
- SNOMED CT 2011_0131
- 362969004
- MedDRA 14.1
- 10014695
- LOINC Version 232
- MTHU021570
- ICD-10-CM Version 2010
- E34.9
- ICD-9-CM Version 2011
- 259.9
- UMLS CUI 2011AA
- C0004364
- SNOMED CT 2011_0131
- 85828009
- MedDRA 14.1
- 10061664
- ICD-10-CM Version 2010
- M30-M36
- CTCAE 1105E
- E11258
Descripción
You have a serum calcitonin test and it shows a >= 20 pcg/mL at the time of screening.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0863135
- SNOMED CT 2011_0131
- 271230004
- MedDRA 14.1
- 10040167
- UMLS CUI 2011AA
- C0392366
- SNOMED CT 2011_0131
- 272393004
- UMLS CUI 2011AA
- C1409616
Descripción
You have or have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1392158
- MedDRA 14.1
- 10070569
- UMLS CUI 2011AA
- C0025268
- SNOMED CT 2011_0131
- 61808009
- MedDRA 14.1
- 10028191
- ICD-10-CM Version 2010
- E31.22
- ICD-9-CM Version 2011
- 258.02
- UMLS CUI 2011AA
- C0025269
- SNOMED CT 2011_0131
- 61530001
- MedDRA 14.1
- 10056420
Descripción
You have cancer (except for skin cancer) or have been in remission from cancer for < 5 years.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0007114
- SNOMED CT 2011_0131
- 372130007
- MedDRA 14.1
- 10040808
- ICD-10-CM Version 2010
- C44.9
- UMLS CUI 2011AA
- C0687702
- MedDRA 14.1
- 10065305
- UMLS CUI 2011AA
- C0439092
- SNOMED CT 2011_0131
- 276139006
- HL7 V3 2006_05
- LT
- UMLS CUI 2011AA
- C0205451
- SNOMED CT 2011_0131
- 34001005
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
Descripción
You have had an organ transplant except for corneal transplant.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0029216
- MedDRA 14.1
- 10061890
- LOINC Version 232
- MTHU000173
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0010042
- SNOMED CT 2011_0131
- 60656008
- MedDRA 14.1
- 10054846
- ICD-9-CM Version 2011
- 11.60
Descripción
You have received treatment within the last 30 days with a drug which has not been regulatory approved.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C1704735
- UMLS CUI 2011AA
- C0205540
- SNOMED CT 2011_0131
- 9571008
Descripción
You have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed on you within 30 days prior to screening.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0021430
Descripción
You have any condition that is a contraindication to or would interfere with medications provided for this study to treat your diabetes.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0011849
- SNOMED CT 2011_0131
- 191044006
Descripción
You have a blood disorder that would interfere with us drawing blood glucose measurement or lab samples.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0018939
- SNOMED CT 2011_0131
- 191124002
- MedDRA 14.1
- 10061590
- ICD-10-CM Version 2010
- D75.9
- ICD-9-CM Version 2011
- 289.9
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0392201
- SNOMED CT 2011_0131
- 33747003
- MedDRA 14.1
- 10005553
- UMLS CUI 2011AA
- C0022877
- SNOMED CT 2011_0131
- 261904005
- LOINC Version 232
- MTHU029808
- UMLS CUI 2011AA
- CL423120
Descripción
You have previously participated or signed an informed consent document for this same type of study and study drug.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C2348583
- UMLS CUI 2011AA
- C0445247
- SNOMED CT 2011_0131
- 262126009
- UMLS CUI 2011AA
- C0035171
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
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167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0014130 (UMLS CUI 2011AA)
362969004 (SNOMED CT 2011_0131)
10014695 (MedDRA 14.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (ICD-9-CM Version 2011)
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
271230004 (SNOMED CT 2011_0131)
10040167 (MedDRA 14.1)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1392158 (UMLS CUI 2011AA)
10070569 (MedDRA 14.1)
C0025268 (UMLS CUI 2011AA)
61808009 (SNOMED CT 2011_0131)
10028191 (MedDRA 14.1)
E31.22 (ICD-10-CM Version 2010)
258.02 (ICD-9-CM Version 2011)
C0025269 (UMLS CUI 2011AA)
61530001 (SNOMED CT 2011_0131)
10056420 (MedDRA 14.1)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007114 (UMLS CUI 2011AA)
372130007 (SNOMED CT 2011_0131)
10040808 (MedDRA 14.1)
C44.9 (ICD-10-CM Version 2010)
C0687702 (UMLS CUI 2011AA)
10065305 (MedDRA 14.1)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0010042 (UMLS CUI 2011AA)
60656008 (SNOMED CT 2011_0131)
10054846 (MedDRA 14.1)
11.60 (ICD-9-CM Version 2011)
C0013227 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1704735 (UMLS CUI 2011AA)
C0205540 (UMLS CUI 2011AA)
9571008 (SNOMED CT 2011_0131)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0392201 (UMLS CUI 2011AA)
33747003 (SNOMED CT 2011_0131)
10005553 (MedDRA 14.1)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
CL423120 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C2348583 (UMLS CUI 2011AA)
C0445247 (UMLS CUI 2011AA)
262126009 (SNOMED CT 2011_0131)
C0035171 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)