ID
43485
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00856284
Link
http://clinicaltrials.gov/show/NCT00856284
Palabras clave
Versiones (3)
- 9/12/13 9/12/13 - Martin Dugas
- 16/4/14 16/4/14 - Julian Varghese
- 20/9/21 20/9/21 -
Subido en
20 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT00856284 Type 2 Diabetes Mellitus
Eligibility
- StudyEvent: Eligibility
Descripción
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
Systolic blood pressure >= 150 mmHg and/or diastolic pressure >= 90.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0871470
- SNOMED CT 2011_0131
- 271649006
- UMLS CUI 2011AA
- C0428883
- SNOMED CT 2011_0131
- 271650006
Descripción
Hemoglobin <= 12 g/dL for males and <= 10 g/dL for females at Screening Visit.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0019046
- SNOMED CT 2011_0131
- 38082009
- MedDRA 14.1
- 10019481
- LOINC Version 232
- LP14449-0
- UMLS CUI 2011AA
- C0086582
- SNOMED CT 2011_0131
- 248153007
- HL7 V3 2006_05
- M
- UMLS CUI 2011AA
- C0086287
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1512346
- HL7 V3 2006_05
- ENC
Descripción
Alanine aminotransferase >= 2.5 times the upper limit of normal at Screening Visit.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C1519815
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1512346
- HL7 V3 2006_05
- ENC
Descripción
Serum creatinine >= 1.5 mg/dL for males and 1.4 for females, or calculated creatinine clearance < 60 L/min.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
- UMLS CUI 2011AA
- C0086582
- SNOMED CT 2011_0131
- 248153007
- HL7 V3 2006_05
- M
- UMLS CUI 2011AA
- C0086287
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
- UMLS CUI 2011AA
- C0444686
- SNOMED CT 2011_0131
- 258090004
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
Descripción
Males intending to impregnate others or donate sperm before, during or within 1 month after participating in the study.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0086582
- SNOMED CT 2011_0131
- 248153007
- HL7 V3 2006_05
- M
- UMLS CUI 2011AA
- C0162425
- UMLS CUI 2011AA
- C0015914
- SNOMED CT 2011_0131
- 55767001
- MedDRA 14.1
- 10016473
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0871414
- MedDRA 14.1
- 10053369
Descripción
A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 yrs.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C2735088
- LOINC Version 232
- MTHU034770
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0553723
- SNOMED CT 2011_0131
- 254651007
- MedDRA 14.1
- 10041834
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0677874
- SNOMED CT 2011_0131
- 103338009
Descripción
A history of laser treatment for diabetic retinopathy within 6 months of screening.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- CL382917
- UMLS CUI 2011AA
- C0011884
- SNOMED CT 2011_0131
- 4855003
- MedDRA 14.1
- 10012689
- LOINC Version 232
- MTHU020818
- ICD-9-CM Version 2011
- 362.0
Descripción
Treated for diabetic gastric paresis, gastric banding, or gastric bypass.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0267176
- SNOMED CT 2011_0131
- 34140002
- MedDRA 14.1
- 10051153
- UMLS CUI 2011AA
- C1960832
- MedDRA 14.1
- 10060785
- UMLS CUI 2011AA
- C0017125
- SNOMED CT 2011_0131
- 442338001
- MedDRA 14.1
- 10061966
Descripción
New York Heart Association Class III or IV heart failure.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1275491
Descripción
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0190211
- SNOMED CT 2011_0131
- 41339005
- MedDRA 14.1
- 10050329
- UMLS CUI 2011AA
- C0948884
- MedDRA 14.1
- 10052597
- UMLS CUI 2011AA
- C0010055
- SNOMED CT 2011_0131
- 232717009
- MedDRA 14.1
- 10011077
- ICD-9-CM Version 2011
- 36.10
- 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
- C0038454
- SNOMED CT 2011_0131
- 230690007
- MedDRA 14.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE 1105E
- E12826
- UMLS CUI 2011AA
- C0007787
- SNOMED CT 2011_0131
- 266257000
- MedDRA 14.1
- 10044390
- LOINC Version 232
- MTHU020810
- ICD-10-CM Version 2010
- G45.9
- ICD-9-CM Version 2011
- 435.9
- CTCAE 1105E
- E12834
Descripción
Known history of human immunodeficiency virus, hepatitis B or C.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0019682
- SNOMED CT 2011_0131
- 19030005
- UMLS CUI 2011AA
- C0019196
- SNOMED CT 2011_0131
- 50711007
- MedDRA 14.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
- UMLS CUI 2011AA
- C1997078
- SNOMED CT 2011_0131
- 429721005
Descripción
Alcohol or substance abuse within 2 years prior to screening.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0085762
- SNOMED CT 2011_0131
- 15167005
- MedDRA 14.1
- 10001584
- LOINC Version 232
- LP36309-0
- ICD-10-CM Version 2010
- F10.1
- ICD-9-CM Version 2011
- 305.0
- UMLS CUI 2011AA
- C0740858
- SNOMED CT 2011_0131
- 66214007
- MedDRA 14.1
- 10066169
- LOINC Version 232
- MTHU019364
Descripción
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1554075
- HL7 V3 2006_05
- NP
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0033080
- SNOMED CT 2011_0131
- 16076005
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0242388
- SNOMED CT 2011_0131
- 414392008
- MedDRA 14.1
- 10063339
- UMLS CUI 2011AA
- C0013231
- SNOMED CT 2011_0131
- 329505003, 80288002
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0013175
- SNOMED CT 2011_0131
- 185922005
Descripción
Any investigational drug within 30 days
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0332285
- SNOMED CT 2011_0131
- 18720000
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
Descripción
Any investigational diabetic drug within 3 months
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1517586
- UMLS CUI 2011AA
- C0241863
- MedDRA 14.1
- 10012641
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0332285
- SNOMED CT 2011_0131
- 18720000
- UMLS CUI 2011AA
- C0205449
- SNOMED CT 2011_0131
- 421291004
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
Descripción
Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening other than metformin
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0935929
- SNOMED CT 2011_0131
- 373245004
- UMLS CUI 2011AA
- C1827106
- SNOMED CT 2011_0131
- 423837000
- UMLS CUI 2011AA
- CL430618
- UMLS CUI 2011AA
- C0456387
- SNOMED CT 2011_0131
- 277046005
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0025598
- SNOMED CT 2011_0131
- 372567009
- LOINC Version 232
- MTHU016062
Descripción
Prior treatment with alogliptin.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C1958126
Descripción
Weight-loss drugs
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0376606
Descripción
Investigational antidiabetics
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1517586
- UMLS CUI 2011AA
- C0935929
- SNOMED CT 2011_0131
- 373245004
Descripción
Oral or systemically injected glucocorticoids
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1527415
- SNOMED CT 2011_0131
- 26643006
- HL7 V3 2006_05
- _OralRoute
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- C1533685
- SNOMED CT 2011_0131
- 59108006
- MedDRA 14.1
- 10052995
- UMLS CUI 2011AA
- C0017710
- SNOMED CT 2011_0131
- 419933005
Descripción
A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0002792
- SNOMED CT 2011_0131
- 39579001
- MedDRA 14.1
- 10002199
- ICD-10-CM Version 2010
- T78.2
- CTCAE 1105E
- E11254
- UMLS CUI 2011AA
- C0081937
- SNOMED CT 2011_0131
- 62412007
- LOINC Version 232
- MTHU007379
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0025598
- SNOMED CT 2011_0131
- 372567009
- LOINC Version 232
- MTHU016062
- UMLS CUI 2011AA
- C0017642
- SNOMED CT 2011_0131
- 387143009
- LOINC Version 232
- MTHU001811
Descripción
Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0040128
- SNOMED CT 2011_0131
- 14304000
- MedDRA 14.1
- 10043709
- ICD-10-CM Version 2010
- E00-E07
- ICD-9-CM Version 2011
- 240-246.99
- UMLS CUI 2011AA
- C0178468
- UMLS CUI 2011AA
- C0018213
- SNOMED CT 2011_0131
- 353295004
- MedDRA 14.1
- 10018706
- ICD-10-CM Version 2010
- E05.0
- UMLS CUI 2011AA
- C0677607
- SNOMED CT 2011_0131
- 21983002
- MedDRA 14.1
- 10019167
- ICD-10-CM Version 2010
- E06.3
- ICD-9-CM Version 2011
- 245.2
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0040137
- SNOMED CT 2011_0131
- 237495005
- MedDRA 14.1
- 10043751
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- StudyEvent: Eligibility
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C0013227 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0242388 (UMLS CUI 2011AA)
414392008 (SNOMED CT 2011_0131)
10063339 (MedDRA 14.1)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0013175 (UMLS CUI 2011AA)
185922005 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0241863 (UMLS CUI 2011AA)
10012641 (MedDRA 14.1)
C0013227 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (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)
373245004 (SNOMED CT 2011_0131)
C1827106 (UMLS CUI 2011AA)
423837000 (SNOMED CT 2011_0131)
CL430618 (UMLS CUI 2011AA)
C0456387 (UMLS CUI 2011AA)
277046005 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C1958126 (UMLS CUI 2011AA)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0017710 (UMLS CUI 2011AA)
419933005 (SNOMED CT 2011_0131)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0002792 (UMLS CUI 2011AA)
39579001 (SNOMED CT 2011_0131)
10002199 (MedDRA 14.1)
T78.2 (ICD-10-CM Version 2010)
E11254 (CTCAE 1105E)
C0081937 (UMLS CUI 2011AA)
62412007 (SNOMED CT 2011_0131)
MTHU007379 (LOINC Version 232)
C0013227 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0017642 (UMLS CUI 2011AA)
387143009 (SNOMED CT 2011_0131)
MTHU001811 (LOINC Version 232)
14304000 (SNOMED CT 2011_0131)
10043709 (MedDRA 14.1)
E00-E07 (ICD-10-CM Version 2010)
240-246.99 (ICD-9-CM Version 2011)
C0178468 (UMLS CUI 2011AA)
C0018213 (UMLS CUI 2011AA)
353295004 (SNOMED CT 2011_0131)
10018706 (MedDRA 14.1)
E05.0 (ICD-10-CM Version 2010)
C0677607 (UMLS CUI 2011AA)
21983002 (SNOMED CT 2011_0131)
10019167 (MedDRA 14.1)
E06.3 (ICD-10-CM Version 2010)
245.2 (ICD-9-CM Version 2011)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0040137 (UMLS CUI 2011AA)
237495005 (SNOMED CT 2011_0131)
10043751 (MedDRA 14.1)
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