ID
44667
Description
ODM derived from http://clinicaltrials.gov/show/NCT01206647
Link
http://clinicaltrials.gov/show/NCT01206647
Keywords
Versions (3)
- 12/7/13 12/7/13 - Martin Dugas
- 4/19/14 4/19/14 - Julian Varghese
- 9/27/21 9/27/21 -
Uploaded on
September 27, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01206647 Diabetes Mellitus, Type 2
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
History of drug or alcohol abuse within the last five years prior to screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0085762
Description
History of severe or multiple allergies
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0439064
- SNOMED CT 2011_0131
- 255204007
Description
Progressive fatal disease
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1302234
- SNOMED CT 2011_0131
- 399166001
- UMLS CUI 2011AA
- C1335499
Description
History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator
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
- 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
- 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
- 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
- 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
Description
Renal insufficiency or history of significant renal diseases (creatinine clearance < 60 ml/min determined using the Cockroft-Goult equation).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1565489
- MedDRA 14.1
- 10038474
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0022658
- SNOMED CT 2011_0131
- 90708001
- MedDRA 14.1
- 10029151
- ICD-10-CM Version 2010
- N18.9
- UMLS CUI 2011AA
- C2711451
- SNOMED CT 2011_0131
- 442407001
Description
Contra-indications for study drugs including contraindications for the rescue drugs
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- C0175673
- SNOMED CT 2011_0131
- 25876001
- UMLS CUI 2011AA
- C0013227
Description
Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0021055
- SNOMED CT 2011_0131
- 940000
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C2348205
- UMLS CUI 2011AA
- C0220807
Description
Pregnancy or breast feeding
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0032961
- SNOMED CT 2011_0131
- 289908002
- MedDRA 14.1
- 10036556
- LOINC Version 232
- MTHU035048
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Description
Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0241028
- SNOMED CT 2011_0131
- 228453005
- MedDRA 14.1
- 10066098
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0420844
- SNOMED CT 2011_0131
- 169450001
- UMLS CUI 2011AA
- CL424925
- UMLS CUI 2011AA
- C1262153
- MedDRA 14.1
- 10062577
- UMLS CUI 2011AA
- C0457572
- SNOMED CT 2011_0131
- 268458002
- UMLS CUI 2011AA
- C3164761
- SNOMED CT 2011_0131
- 449038007
- UMLS CUI 2011AA
- C0036899
- SNOMED CT 2011_0131
- 47037006
- MedDRA 14.1
- 10029805
- UMLS CUI 2011AA
- C0420842
- SNOMED CT 2011_0131
- 268457007
Description
Treatment with any other investigational drug within 3 months prior to screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0013230
Description
Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0457432
- SNOMED CT 2011_0131
- 258143003
- UMLS CUI 2011AA
- C2348205
- UMLS CUI 2011AA
- C0392360
- SNOMED CT 2011_0131
- 410666004 230165009
- LOINC Version 232
- MTHU008862
- UMLS CUI 2011AA
- C0332196
- SNOMED CT 2011_0131
- 77765009
- UMLS CUI 2011AA
- C1272703
- SNOMED CT 2011_0131
- 385669000
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
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