ID
43449
Description
ODM derived from http://clinicaltrials.gov/show/NCT00770653
Link
http://clinicaltrials.gov/show/NCT00770653
Keywords
Versions (3)
- 12/9/13 12/9/13 - Martin Dugas
- 4/16/14 4/16/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT00770653 Diabetes Mellitus
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
Type 1 diabetes mellitus.
Data type
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
Insulin-dependent type 2 diabetes mellitus.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1852092
Description
Treatment or history of treatment with any insulin formulation other than emergency for more than 2 weeks.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C0021641
- SNOMED CT 2011_0131
- 67866001
- LOINC Version 232
- MTHU019392
- UMLS CUI 2011AA
- C1705957
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0175673
- SNOMED CT 2011_0131
- 25876001
Description
Treatment with other oral antidiabetic drugs in addition to metformin within the last 12 weeks.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C1527415
- SNOMED CT 2011_0131
- 26643006
- HL7 V3 2006_05
- _OralRoute
- UMLS CUI 2011AA
- C0935929
- SNOMED CT 2011_0131
- 373245004
- UMLS CUI 2011AA
- C1524062
- LOINC Version 232
- MTHU013802
- UMLS CUI 2011AA
- C0025598
- SNOMED CT 2011_0131
- 372567009
- LOINC Version 232
- MTHU016062
Description
Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C2348205
- UMLS CUI 2011AA
- C0220807
Description
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:
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1512806
- UMLS CUI 2011AA
- C1554075
- HL7 V3 2006_05
- NP
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C1521941
- LOINC Version 232
- MTHU034709
- UMLS CUI 2011AA
- C1360419
- 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
Description
Heparin (and heparin-like drugs)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0019134
- SNOMED CT 2011_0131
- 372877000
- LOINC Version 232
- MTHU003766
- UMLS CUI 2011AA
- C2348205
- UMLS CUI 2011AA
- C0013227
Description
coumarin
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0010206
- SNOMED CT 2011_0131
- 373307003
Description
phenprocoumon
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0031444
- SNOMED CT 2011_0131
- 59488002
- LOINC Version 232
- MTHU016364
Description
hirudin
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0019573
- SNOMED CT 2011_0131
- 414407009
- LOINC Version 232
- MTHU026944
Description
Protein C
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0033621
- SNOMED CT 2011_0131
- 25525005
- LOINC Version 232
- MTHU021552
Description
Fondaparinux
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0701492
- SNOMED CT 2011_0131
- 395236007
- LOINC Version 232
- MTHU025935
Description
antithrombin III
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0003438
- SNOMED CT 2011_0131
- 34086003
- LOINC Version 232
- MTHU008554
Description
Peroxisome Proliferation Activating Receptor (gamma) agonists
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0166417
- UMLS CUI 2011AA
- C0243192
Description
Treatment within the last 12 weeks with:
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C1517741
- UMLS CUI 2011AA
- C0205458
- SNOMED CT 2011_0131
- 82809009
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
Description
fibrates
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1449704
Description
gemfibrozil
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0017245
- SNOMED CT 2011_0131
- 35282000
- LOINC Version 232
- MTHU002557
Description
niacin
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0027996
- SNOMED CT 2011_0131
- 273943001
- LOINC Version 232
- MTHU002113
Description
Rifampicin
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0035608
- SNOMED CT 2011_0131
- 387159009
- LOINC Version 232
- MTHU008474
Description
Changes in dosage of any statin treatment to lower low-density lipoprotein within 2 weeks before study entry and during study participation interval.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2347524
- UMLS CUI 2011AA
- C0360714
- SNOMED CT 2011_0131
- 372912004
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C2003888
- UMLS CUI 2011AA
- C0023823
- SNOMED CT 2011_0131
- 22244007
- LOINC Version 232
- MTHU005011
Description
Changes in dosage of any anticoagulant treatment with acetyl salicylic acid and/or clopidogrel within 2 weeks before study entry and during study participation interval.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2347524
- UMLS CUI 2011AA
- C0150457
- SNOMED CT 2011_0131
- 182764009
- MedDRA 14.1
- 10053468
- UMLS CUI 2011AA
- C0004057
- SNOMED CT 2011_0131
- 7947003
- UMLS CUI 2011AA
- C0070166
- SNOMED CT 2011_0131
- 386952008
Description
Start of statin and/or anticoagulant treatment during study participation interval.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0360714
- SNOMED CT 2011_0131
- 372912004
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0150457
- SNOMED CT 2011_0131
- 182764009
- MedDRA 14.1
- 10053468
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
Description
History of severe or multiple allergies and/ or acute severe infections.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0455609
- SNOMED CT 2011_0131
- 161614004
- UMLS CUI 2011AA
- C0275518
- SNOMED CT 2011_0131
- 63171007
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
Description
Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0332189
- SNOMED CT 2011_0131
- 272128006
- 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
Description
Progressive fatal disease.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C1335499
Description
Any elective surgery during study participation.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0206058
- SNOMED CT 2011_0131
- 274075007
- MedDRA 14.1
- 10058829
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
Description
History of drug or alcohol abuse within the last 5 years.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0085762
Description
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase and/or aspartate aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, glomerular filtration rate < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator, history of macular edema.
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0007222
- SNOMED CT 2011_0131
- 105980002
- MedDRA 14.1
- 10007649
- ICD-9-CM Version 2011
- 429.2
- UMLS CUI 2011AA
- C1319793
- SNOMED CT 2011_0131
- 420300004
- MedDRA 14.1
- 10064079
- 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
- C0035204
- SNOMED CT 2011_0131
- 50043002
- MedDRA 14.1
- 10038683
- ICD-10-CM Version 2010
- J98.9
- ICD-9-CM Version 2011
- 519.9
- UMLS CUI 2011AA
- C0017178
- SNOMED CT 2011_0131
- 119292006
- MedDRA 14.1
- 10017944
- UMLS CUI 2011AA
- C1869009
- MedDRA 14.1
- 20000005
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C0022658
- SNOMED CT 2011_0131
- 90708001
- MedDRA 14.1
- 10029151
- ICD-10-CM Version 2010
- N18.9
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
- UMLS CUI 2011AA
- C0017654
- SNOMED CT 2011_0131
- 80274001
- MedDRA 14.1
- 10018355
- UMLS CUI 2011AA
- C2711451
- SNOMED CT 2011_0131
- 442407001
- UMLS CUI 2011AA
- C0027765
- SNOMED CT 2011_0131
- 118940003
- MedDRA 14.1
- 10029202
- ICD-10-CM Version 2010
- G98.8
- ICD-9-CM Version 2011
- 349.9
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
- 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
- C0271051
- SNOMED CT 2011_0131
- 37231002
- MedDRA 14.1
- 10025415
Description
Blood donation within the last 30 days.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0005794
- SNOMED CT 2011_0131
- 25179006
- UMLS CUI 2011AA
- C0332285
- SNOMED CT 2011_0131
- 18720000
- UMLS CUI 2011AA
- C1517741
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
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Eligibility
- StudyEvent: Eligibility
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C0013227 (UMLS CUI 2011AA)
C2348205 (UMLS CUI 2011AA)
C0220807 (UMLS CUI 2011AA)
C1554075 (UMLS CUI 2011AA)
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C1521941 (UMLS CUI 2011AA)
MTHU034709 (LOINC Version 232)
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372912004 (SNOMED CT 2011_0131)
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E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
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24484000 (SNOMED CT 2011_0131)
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274075007 (SNOMED CT 2011_0131)
10058829 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
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10029151 (MedDRA 14.1)
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10040230 (MedDRA 14.1)
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80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
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191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C0271051 (UMLS CUI 2011AA)
37231002 (SNOMED CT 2011_0131)
10025415 (MedDRA 14.1)
25179006 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)