ID
42140
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT01408095
Link
http://clinicaltrials.gov/show/NCT01408095
Palabras clave
Versiones (4)
- 17/4/13 17/4/13 - Martin Dugas
- 20/4/14 20/4/14 - Julian Varghese
- 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
- 20/9/21 20/9/21 -
Subido en
13 de abril de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT01408095 Diabetes Mellitus, Type 2
Eligibility
- StudyEvent: Eligibility
Descripción
Ausschlusskriterien
Descripción
Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0240016
- SNOMED CT 2011_0131
- 246491008
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0935929
- SNOMED CT 2011_0131
- 373245004
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0025598
- SNOMED CT 2011_0131
- 372567009
- LOINC Version 232
- MTHU016062
- UMLS CUI 2011AA
- C0038766
- UMLS CUI 2011AA
- C1579432
Descripción
Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0017178
- SNOMED CT 2011_0131
- 119292006
- MedDRA 14.1
- 10017944
- UMLS CUI 2011AA
- C1280500
- SNOMED CT 2011_0131
- 253861007
- UMLS CUI 2011AA
- C0017127
- UMLS CUI 2011AA
- C0232572
- SNOMED CT 2011_0131
- 36735000
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0017125
- SNOMED CT 2011_0131
- 442338001
- MedDRA 14.1
- 10061966
- UMLS CUI 2011AA
- C1261985
- MedDRA 14.1
- 10060785
- UMLS CUI 2011AA
- C0038895
Descripción
Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0020615
- SNOMED CT 2011_0131
- 302866003
- MedDRA 14.1
- 10020993
- ICD-10-CM Version 2010
- E16.2
- ICD-9-CM Version 2011
- 251.2
- CTCAE 1105E
- E12322
- UMLS CUI 2011AA
- C0853088
- MedDRA 14.1
- 10020997
- UMLS CUI 2011AA
- C1546435
- HL7 V3 2006_05
- ER
- UMLS CUI 2011AA
- C1554196
- HL7 V3 2006_05
- ENC
- UMLS CUI 2011AA
- C0019993
- SNOMED CT 2011_0131
- 394656005
- MedDRA 14.1
- 10054112
- UMLS CUI 2011AA
- CL420107
- UMLS CUI 2011AA
- C0858269
- MedDRA 14.1
- 10024858
Descripción
Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1512806
- UMLS CUI 2011AA
- C0033080
- SNOMED CT 2011_0131
- 16076005
- UMLS CUI 2011AA
- C0013231
- SNOMED CT 2011_0131
- 329505003, 80288002
- UMLS CUI 2011AA
- C0392760
- SNOMED CT 2011_0131
- 247591002
- UMLS CUI 2011AA
- C0005910
- SNOMED CT 2011_0131
- 27113001
- LOINC Version 232
- MTHU001885
Descripción
Have cardiac disease with functional status that is New York Heart Association [NYHA] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- UMLS CUI 2011AA
- C1319794
- SNOMED CT 2011_0131
- 421704003
- MedDRA 14.1
- 10064080
- UMLS CUI 2011AA
- C1319795
- SNOMED CT 2011_0131
- 420913000
- MedDRA 14.1
- 10064081
- UMLS CUI 2011AA
- C1319796
- SNOMED CT 2011_0131
- 422293003
- MedDRA 14.1
- 10064082
- UMLS CUI 2011AA
- C1275835
- SNOMED CT 2011_0131
- 399211009
- UMLS CUI 2011AA
- C0002965
- SNOMED CT 2011_0131
- 4557003
- MedDRA 14.1
- 10002388
- ICD-10-CM Version 2010
- I20.0
- ICD-9-CM Version 2011
- 411.1
- UMLS CUI 2011AA
- C0205434
- SNOMED CT 2011_0131
- 5650002
- UMLS CUI 2011AA
- C0018802
- SNOMED CT 2011_0131
- 42343007
- MedDRA 14.1
- 10007559
- LOINC Version 232
- MTHU020787
- ICD-10-CM Version 2010
- I50.9
- ICD-9-CM Version 2011
- 428.0
Descripción
Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1868885
- MedDRA 14.1
- 10066860
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0020540
- SNOMED CT 2011_0131
- 70272006
- MedDRA 14.1
- 10025600
- UMLS CUI 2011AA
- C0035067
- SNOMED CT 2011_0131
- 302233006
- MedDRA 14.1
- 10038378
- UMLS CUI 2011AA
- C0428895
- SNOMED CT 2011_0131
- 251080003
- MedDRA 14.1
- 10023533
- UMLS CUI 2011AA
- C0020651
- SNOMED CT 2011_0131
- 28651003
- MedDRA 14.1
- 10031127
- ICD-10-CM Version 2010
- I95.1
- ICD-9-CM Version 2011
- 458.0
- UMLS CUI 2011AA
- C0205360
- SNOMED CT 2011_0131
- 58158008
- LOINC Version 232
- MTHU015276
- UMLS CUI 2011AA
- C0178602
- SNOMED CT 2011_0131
- 260911001
- UMLS CUI 2011AA
- C0003364
- SNOMED CT 2011_0131
- 372586001
Descripción
Have a QTcB (Bazett's-corrected QT interval) interval > 450 msec for men or > 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1882512
- UMLS CUI 2011AA
- C1272706
- SNOMED CT 2011_0131
- 385673002
- UMLS CUI 2011AA
- C0025266
- SNOMED CT 2011_0131
- 339947000
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0042514
- SNOMED CT 2011_0131
- 25569003
- MedDRA 14.1
- 10047302
- ICD-10-CM Version 2010
- I47.2
- CTCAE 1105E
- E10239
- UMLS CUI 2011AA
- C0039070
- SNOMED CT 2011_0131
- 272030005
- MedDRA 14.1
- 10042772
- LOINC Version 232
- MTHU020851
- ICD-10-CM Version 2010
- R55
- ICD-9-CM Version 2011
- 780.2
- CTCAE 1105E
- E12832
- UMLS CUI 2011AA
- C1705492
- UMLS CUI 2011AA
- C0681841
- LOINC Version 232
- MTHU013812
Descripción
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0037088
- SNOMED CT 2011_0131
- 404684003
- 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
- C0267797
- SNOMED CT 2011_0131
- 37871000
- MedDRA 14.1
- 10019727
- ICD-10-CM Version 2010
- B17.9
- UMLS CUI 2011AA
- C0019189
- SNOMED CT 2011_0131
- 76783007
- MedDRA 14.1
- 10008909
- ICD-10-CM Version 2010
- K73.9
- ICD-9-CM Version 2011
- 571.40
- UMLS CUI 2011AA
- C0877359
- MedDRA 14.1
- 10048557
Descripción
Are currently receiving renal dialysis, have a serum creatinine > 2.0 mg/dL (177 micromol/L) or a calculated creatinine clearance of < 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0917873
- SNOMED CT 2011_0131
- 265764009
- MedDRA 14.1
- 10049051
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
- UMLS CUI 2011AA
- C1441506
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- C0025598
- SNOMED CT 2011_0131
- 372567009
- LOINC Version 232
- MTHU016062
- UMLS CUI 2011AA
- C0039798
Descripción
Have fasting state hypertriglyceridemia (defined as > 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1976106
- LOINC Version 232
- MTHU026462
- UMLS CUI 2011AA
- C0020557
- SNOMED CT 2011_0131
- 302870006
- MedDRA 14.1
- 10020869
- CTCAE 1105E
- E12299
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C0750557
- UMLS CUI 2011AA
- C1512806
- UMLS CUI 2011AA
- C0003367
- SNOMED CT 2011_0131
- 57952007
- UMLS CUI 2011AA
- C0178602
- SNOMED CT 2011_0131
- 260911001
- UMLS CUI 2011AA
- C0027552
- SNOMED CT 2011_0131
- 410525008
- UMLS CUI 2011AA
- C0205360
- SNOMED CT 2011_0131
- 58158008
- LOINC Version 232
- MTHU015276
Descripción
Are receiving chronic (for > 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- C0744425
- MedDRA 14.1
- 10071104
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0360289
- SNOMED CT 2011_0131
- 350088003
- UMLS CUI 2011AA
- C0556393
- SNOMED CT 2011_0131
- 228376009
Descripción
Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for < 5 years
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- CL415147
- 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
- C0687702
- MedDRA 14.1
- 10065305
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007, 254701007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0553723
- SNOMED CT 2011_0131
- 254651007
- MedDRA 14.1
- 10041834
- UMLS CUI 2011AA
- C0851140
- SNOMED CT 2011_0131
- 92564006
- MedDRA 14.1
- 10061809
- ICD-10-CM Version 2010
- D06.9
- ICD-9-CM Version 2011
- 233.1
- UMLS CUI 2011AA
- C0154088
- SNOMED CT 2011_0131
- 92691004
- MedDRA 14.1
- 10036912
- ICD-10-CM Version 2010
- D07.5
- ICD-9-CM Version 2011
- 233.4
Descripción
Have a history of seizure disorder
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0014544
- SNOMED CT 2011_0131
- 84757009, 313307000
- MedDRA 14.1
- 10015037
- LOINC Version 232
- MTHU020586
- ICD-10-CM Version 2010
- G40.9
- ICD-9-CM Version 2011
- 345.9
Descripción
Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C1283828
- SNOMED CT 2011_0131
- 363703001
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C2962753
Descripción
Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1512806
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0332324
- SNOMED CT 2011_0131
- 83185005
- UMLS CUI 2011AA
- C0178623
- UMLS CUI 2011AA
- C1142644
- SNOMED CT 2011_0131
- 422741004
- UMLS CUI 2011AA
- C1706062
- UMLS CUI 2011AA
- CL407604
- UMLS CUI 2011AA
- C0678793
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392521001 (SNOMED CT 2011_0131)
C0042514 (UMLS CUI 2011AA)
25569003 (SNOMED CT 2011_0131)
10047302 (MedDRA 14.1)
I47.2 (ICD-10-CM Version 2010)
E10239 (CTCAE 1105E)
C0039070 (UMLS CUI 2011AA)
272030005 (SNOMED CT 2011_0131)
10042772 (MedDRA 14.1)
MTHU020851 (LOINC Version 232)
R55 (ICD-10-CM Version 2010)
780.2 (ICD-9-CM Version 2011)
E12832 (CTCAE 1105E)
C1705492 (UMLS CUI 2011AA)
C0681841 (UMLS CUI 2011AA)
MTHU013812 (LOINC Version 232)
404684003 (SNOMED CT 2011_0131)
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)
C0267797 (UMLS CUI 2011AA)
37871000 (SNOMED CT 2011_0131)
10019727 (MedDRA 14.1)
B17.9 (ICD-10-CM Version 2010)
C0019189 (UMLS CUI 2011AA)
76783007 (SNOMED CT 2011_0131)
10008909 (MedDRA 14.1)
K73.9 (ICD-10-CM Version 2010)
571.40 (ICD-9-CM Version 2011)
C0877359 (UMLS CUI 2011AA)
10048557 (MedDRA 14.1)
C0917873 (UMLS CUI 2011AA)
265764009 (SNOMED CT 2011_0131)
10049051 (MedDRA 14.1)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1441506 (UMLS CUI 2011AA)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
MTHU026462 (LOINC Version 232)
C0020557 (UMLS CUI 2011AA)
302870006 (SNOMED CT 2011_0131)
10020869 (MedDRA 14.1)
E12299 (CTCAE 1105E)
C1409616 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C1512806 (UMLS CUI 2011AA)
C0003367 (UMLS CUI 2011AA)
57952007 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0744425 (UMLS CUI 2011AA)
10071104 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0360289 (UMLS CUI 2011AA)
350088003 (SNOMED CT 2011_0131)
C0556393 (UMLS CUI 2011AA)
228376009 (SNOMED CT 2011_0131)
55561003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0687702 (UMLS CUI 2011AA)
10065305 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0154088 (UMLS CUI 2011AA)
92691004 (SNOMED CT 2011_0131)
10036912 (MedDRA 14.1)
D07.5 (ICD-10-CM Version 2010)
233.4 (ICD-9-CM Version 2011)
392521001 (SNOMED CT 2011_0131)
C0014544 (UMLS CUI 2011AA)
84757009, 313307000 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
15240007 (SNOMED CT 2011_0131)
C1283828 (UMLS CUI 2011AA)
363703001 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2962753 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0332324 (UMLS CUI 2011AA)
83185005 (SNOMED CT 2011_0131)
C0178623 (UMLS CUI 2011AA)
C1142644 (UMLS CUI 2011AA)
422741004 (SNOMED CT 2011_0131)
C1706062 (UMLS CUI 2011AA)
CL407604 (UMLS CUI 2011AA)
C0678793 (UMLS CUI 2011AA)