ID
44635
Description
ODM derived from http://clinicaltrials.gov/show/NCT01126580
Lien
http://clinicaltrials.gov/show/NCT01126580
Mots-clés
Versions (3)
- 06/12/2013 06/12/2013 - Martin Dugas
- 17/04/2014 17/04/2014 - Julian Varghese
- 27/09/2021 27/09/2021 -
Téléchargé le
27 septembre 2021
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY 4.0
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Eligibility NCT01126580 Diabetes Mellitus, Type 2
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Description
You have type 1 diabetes mellitus
Type de données
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
Description
You are being or have been treated with any of the following medications:
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- CL407060
- UMLS CUI 2011AA
- C0332282
- SNOMED CT 2011_0131
- 255260001
- UMLS CUI 2011AA
- C0013227
Description
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,
Type de données
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
Description
b)GLP-1 analogs within 3 months prior to this screening,
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL430618
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Description
c)drugs to cause weight loss within 3 months prior to screening,
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0678227
- SNOMED CT 2011_0131
- 23981006
- 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
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Description
d)thiazolidinediones (TZDs)within 3 months prior to screening,
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1257987
- SNOMED CT 2011_0131
- 109086001
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Description
e)chronically treated(>= 14 days) an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening,or
Type de données
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
Description
f)illegal drugs.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0086190
- SNOMED CT 2011_0131
- 77657003
- LOINC Version 232
- MTHU035698
Description
You have had 1 or more cases of uncontrolled diabetes which required hospitalization in the 6 months prior to screening,
Type de données
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
Description
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.
Type de données
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
Description
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.
Type de données
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
Description
You have a serum creatinine result which shows a >= 1.5 mg/dL for men or >= 1.4 mg/dL for women.
Type de données
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
Description
You have a problem with your liver or pancreas.
Type de données
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
Description
You have creatinine clearance result which shows < 60 mL/minute, evidence of a significant active, uncontrolled endocrine (hormone) or active autoimmune abnormality.
Type de données
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
Description
You have a serum calcitonin test and it shows a >= 20 pcg/mL at the time of screening.
Type de données
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
Description
You have or have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0342190
- 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
Description
You have cancer (except for skin cancer) or have been in remission from cancer for < 5 years.
Type de données
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
Description
You have had an organ transplant except for corneal transplant.
Type de données
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
Description
You have received treatment within the last 30 days with a drug which has not been regulatory approved.
Type de données
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
Description
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.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0021430
Description
You have any condition that is a contraindication to or would interfere with medications provided for this study to treat your diabetes.
Type de données
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
Description
You have a blood disorder that would interfere with us drawing blood glucose measurement or lab samples.
Type de données
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
Description
You have previously participated or signed an informed consent document for this same type of study and study drug.
Type de données
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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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
44054006 (SNOMED CT 2011_0131)
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410525008 (SNOMED CT 2011_0131)
166435006 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
20572008 (SNOMED CT 2011_0131)
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C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
398166005 (SNOMED CT 2011_0131)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
C0039593 (UMLS CUI 2011AA)
69998004 (SNOMED CT 2011_0131)
C0036588 (UMLS CUI 2011AA)
C1720154 (UMLS CUI 2011AA)
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C2976495 (UMLS CUI 2011AA)
C0032042 (UMLS CUI 2011AA)
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783.21 (ICD-9-CM Version 2011)
E12228 (CTCAE 1105E)
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288556008 (SNOMED CT 2011_0131)
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109086001 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
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C1456587 (UMLS CUI 2011AA)
10068900 (MedDRA 14.1)
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10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
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E10152 (CTCAE 1105E)
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113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
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235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
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3855007 (SNOMED CT 2011_0131)
10033616 (MedDRA 14.1)
K86.9 (ICD-10-CM Version 2010)
577.9 (ICD-9-CM Version 2011)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
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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)
C0342190 (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)
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