ID

43448

Description

ODM derived from http://clinicaltrials.gov/show/NCT00770445

Link

http://clinicaltrials.gov/show/NCT00770445

Keywords

  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 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 NCT00770445 Diabetes Mellitus

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 30 Years to 75 Years
Description

age 30 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Has Diabetes Mellitus type 2.
Description

Has Diabetes Mellitus type 2.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
Hemoglobin, Glycosylated
Description

A glycosylated hemoglobin level >= 6.5% and < 8.5%.

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
259689004
LOINC Version 232
MTHU020323
Treatment with the following insulins with or without Oral Antidiabetic Therapy since 3 months:
Description

Treatment with the following insulins with or without Oral Antidiabetic Therapy since 3 months:

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
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
C0039798
Long acting basal insulin analogs
Description

Long acting basal insulin analogs

Data type

boolean

Alias
UMLS CUI 2011AA
C0205112
SNOMED CT 2011_0131
57195005
UMLS CUI 2011AA
C0304870
SNOMED CT 2011_0131
25305005
UMLS CUI 2011AA
C0243071
Neutral protamine hagedorn insulin
Description

NPH insulin

Data type

boolean

Alias
UMLS CUI 2011AA
C0021658
SNOMED CT 2011_0131
66384003
LOINC Version 232
MTHU019391
Combination insulin with 1-2 daily doses except intensified insulin therapies.
Description

Combination insulin with 1-2 daily doses except intensified insulin therapies.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C0556895
SNOMED CT 2011_0131
229554006
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0522510
SNOMED CT 2011_0131
103370009
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C0039798
Body mass index
Description

A body mass index >= 25.

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Description

Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0232973
SNOMED CT 2011_0131
60001007
UMLS CUI 2011AA
C2826207
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Has a history of type 1 diabetes mellitus.
Description

Has a history of type 1 diabetes mellitus.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011854
Has uncontrolled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 95mmHg) or change of antihypertensive treatment within the last 2 weeks.
Description

Has uncontrolled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 95mmHg) or change of antihypertensive treatment within the last 2 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C0585941
SNOMED CT 2011_0131
308116003
Acute infection
Description

Has acute infections.

Data type

boolean

Alias
UMLS CUI 2011AA
C0275518
SNOMED CT 2011_0131
63171007
Has anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure.
Description

Has anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure.

Data type

boolean

Alias
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Has a history of severe or multiple allergies.
Description

Has a 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
C0455609
SNOMED CT 2011_0131
161614004
History of drug or alcohol abuse in the past 5 years
Description

History of drug or alcohol abuse in the past 5 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0085762
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (Alanine Aminotransferase and/or Aspartate Aminotransferase > 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
Description

A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (Alanine Aminotransferase and/or Aspartate Aminotransferase > 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

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
History of macular edema.
Description

History of macular edema.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0271051
SNOMED CT 2011_0131
37231002
MedDRA 14.1
10025415
State after kidney transplantation.
Description

State after kidney transplantation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0022671
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
Serum Potassium Measurement
Description

Serum potassium > 5.5 mmol/L.

Data type

boolean

Alias
UMLS CUI 2011AA
C0302353
SNOMED CT 2011_0131
271236005
MedDRA 14.1
10040376
History of primary hyperaldosteronism.
Description

History of primary hyperaldosteronism.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1384514
SNOMED CT 2011_0131
190507007
MedDRA 14.1
10036692
ICD-10-CM Version 2010
E26.01
ICD-9-CM Version 2011
255.12
Acute myocardial infarction, open heart surgery or cerebral event (stroke/ Transitory Ischemic Attack) within the previous 12 months.
Description

Acute myocardial infarction, open heart surgery or cerebral event (stroke/ Transitory Ischemic Attack) within the previous 12 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0155626
SNOMED CT 2011_0131
57054005
MedDRA 14.1
10000891
ICD-10-CM Version 2010
I21
ICD-9-CM Version 2011
410
UMLS CUI 2011AA
C0189745
SNOMED CT 2011_0131
2598006
MedDRA 14.1
10048935
UMLS CUI 2011AA
C0228174
SNOMED CT 2011_0131
372073000
UMLS CUI 2011AA
C0441471
SNOMED CT 2011_0131
272379006
LOINC Version 232
MTHU019184
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
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:
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
C1554075
HL7 V3 2006_05
NP
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
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
Pre-treatment with gemfibrozil within the last 12 weeks.
Description

Pre-treatment with gemfibrozil within the last 12 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C1882440
UMLS CUI 2011AA
C0017245
SNOMED CT 2011_0131
35282000
LOINC Version 232
MTHU002557
Pre-treatment with rifampicin within the last 12 weeks.
Description

Pre-treatment with rifampicin within the last 12 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C1882440
UMLS CUI 2011AA
C0035608
SNOMED CT 2011_0131
387159009
LOINC Version 232
MTHU008474
Treatment with thiazolidinediones within the past 3 months.
Description

Treatment with thiazolidinediones within the past 3 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1257987
SNOMED CT 2011_0131
109086001
If statin therapy applicable: Change of medication within the last 4 weeks.
Description

If statin therapy applicable: Change of medication within the last 4 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0360714
SNOMED CT 2011_0131
372912004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1706839
UMLS CUI 2011AA
C0580105
SNOMED CT 2011_0131
182838006
Has used non-steroidal anti-inflammatory agents including low dose ASA or Cox-2-inhibitors if therapy has been initiated within the last 4 weeks.
Description

Has used non-steroidal anti-inflammatory agents including low dose ASA or Cox-2-inhibitors if therapy has been initiated within the last 4 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
UMLS CUI 2011AA
C0721444
UMLS CUI 2011AA
C1257954
SNOMED CT 2011_0131
387050005
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Treatment with any other investigational drug within 4 weeks before trial entry.
Description

Treatment with any other investigational drug within 4 weeks before trial entry.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
Any elective surgery during study participation.
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
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.
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
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
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
History of dehydration, precoma diabeticorum or shock or diabetic ketoacidosis within the past year prior to screening visit.
Description

History of dehydration, precoma diabeticorum or shock or diabetic ketoacidosis within the past year prior to screening visit.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0011175
SNOMED CT 2011_0131
34095006
MedDRA 14.1
10012174
LOINC Version 232
MTHU020843
ICD-10-CM Version 2010
E86.0
ICD-9-CM Version 2011
276.51
CTCAE 1105E
E12258
UMLS CUI 2011AA
C0241863
MedDRA 14.1
10012641
UMLS CUI 2011AA
C1142529
MedDRA 14.1
10058705
UMLS CUI 2011AA
C0851302
SNOMED CT 2011_0131
360546002
MedDRA 14.1
10040576
UMLS CUI 2011AA
C0011880
SNOMED CT 2011_0131
420422005
MedDRA 14.1
10012671
ICD-9-CM Version 2011
250.1
Acute or scheduled investigation with iodine containing radiopaque material.
Description

Acute or scheduled investigation with iodine containing radiopaque material.

Data type

boolean

Alias
UMLS CUI 2011AA
C0430007
UMLS CUI 2011AA
C0021968
SNOMED CT 2011_0131
325330005
LOINC Version 232
MTHU009375
UMLS CUI 2011AA
C0332256
SNOMED CT 2011_0131
42504009
UMLS CUI 2011AA
C0302587
UMLS CUI 2011AA
C0520510
SNOMED CT 2011_0131
260769002
LOINC Version 232
MTHU013790
HL7 V3 2006_05
MAT
Uncontrolled unstable angina pectoris.
Description

Uncontrolled unstable angina pectoris.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
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
Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm.
Description

Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm.

Data type

boolean

Alias
UMLS CUI 2011AA
C0262926
SNOMED CT 2011_0131
417662000
LOINC Version 232
MTHU027722
UMLS CUI 2011AA
C0031046
SNOMED CT 2011_0131
3238004
MedDRA 14.1
10034484
CTCAE 1105E
E10180
UMLS CUI 2011AA
C0027059
SNOMED CT 2011_0131
50920009
MedDRA 14.1
10028606
ICD-10-CM Version 2010
I51.4
ICD-9-CM Version 2011
429.0
CTCAE 1105E
E10157
UMLS CUI 2011AA
C0014118
SNOMED CT 2011_0131
56819008
MedDRA 14.1
10014665
ICD-9-CM Version 2011
424.90
UMLS CUI 2011AA
C0034065
SNOMED CT 2011_0131
59282003
MedDRA 14.1
10037377
ICD-10-CM Version 2010
I26
ICD-9-CM Version 2011
415.1
UMLS CUI 2011AA
C0003507
SNOMED CT 2011_0131
60573004
MedDRA 14.1
10002918
UMLS CUI 2011AA
C0003486
SNOMED CT 2011_0131
67362008
MedDRA 14.1
10002882
ICD-10-CM Version 2010
I71.9

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 30 Years to 75 Years
Item
age 30 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Has Diabetes Mellitus type 2.
Item
Has Diabetes Mellitus type 2.
boolean
C0011860 (UMLS CUI 2011AA)
A glycosylated hemoglobin level >= 6.5% and < 8.5%.
Item
Hemoglobin, Glycosylated
boolean
C0019018 (UMLS CUI 2011AA)
259689004 (SNOMED CT 2011_0131)
MTHU020323 (LOINC Version 232)
Treatment with the following insulins with or without Oral Antidiabetic Therapy since 3 months:
Item
Treatment with the following insulins with or without Oral Antidiabetic Therapy since 3 months:
boolean
C0039798 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Long acting basal insulin analogs
Item
Long acting basal insulin analogs
boolean
C0205112 (UMLS CUI 2011AA)
57195005 (SNOMED CT 2011_0131)
C0304870 (UMLS CUI 2011AA)
25305005 (SNOMED CT 2011_0131)
C0243071 (UMLS CUI 2011AA)
NPH insulin
Item
Neutral protamine hagedorn insulin
boolean
C0021658 (UMLS CUI 2011AA)
66384003 (SNOMED CT 2011_0131)
MTHU019391 (LOINC Version 232)
Combination insulin with 1-2 daily doses except intensified insulin therapies.
Item
Combination insulin with 1-2 daily doses except intensified insulin therapies.
boolean
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
A body mass index >= 25.
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Item
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C2826207 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Has a history of type 1 diabetes mellitus.
Item
Has a history of type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI 2011AA)
Has uncontrolled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 95mmHg) or change of antihypertensive treatment within the last 2 weeks.
Item
Has uncontrolled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 95mmHg) or change of antihypertensive treatment within the last 2 weeks.
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0585941 (UMLS CUI 2011AA)
308116003 (SNOMED CT 2011_0131)
Has acute infections.
Item
Acute infection
boolean
C0275518 (UMLS CUI 2011AA)
63171007 (SNOMED CT 2011_0131)
Has anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure.
Item
Has anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure.
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Has a history of severe or multiple allergies.
Item
Has a history of severe or multiple allergies.
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0455609 (UMLS CUI 2011AA)
161614004 (SNOMED CT 2011_0131)
History of drug or alcohol abuse in the past 5 years
Item
History of drug or alcohol abuse in the past 5 years
boolean
C0085762 (UMLS CUI 2011AA)
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (Alanine Aminotransferase and/or Aspartate Aminotransferase > 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
Item
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (Alanine Aminotransferase and/or Aspartate Aminotransferase > 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
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C1319793 (UMLS CUI 2011AA)
420300004 (SNOMED CT 2011_0131)
10064079 (MedDRA 14.1)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0035204 (UMLS CUI 2011AA)
50043002 (SNOMED CT 2011_0131)
10038683 (MedDRA 14.1)
J98.9 (ICD-10-CM Version 2010)
519.9 (ICD-9-CM Version 2011)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C1869009 (UMLS CUI 2011AA)
20000005 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0017654 (UMLS CUI 2011AA)
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)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
History of macular edema.
Item
History of macular edema.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0271051 (UMLS CUI 2011AA)
37231002 (SNOMED CT 2011_0131)
10025415 (MedDRA 14.1)
State after kidney transplantation.
Item
State after kidney transplantation.
boolean
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
Serum potassium > 5.5 mmol/L.
Item
Serum Potassium Measurement
boolean
C0302353 (UMLS CUI 2011AA)
271236005 (SNOMED CT 2011_0131)
10040376 (MedDRA 14.1)
History of primary hyperaldosteronism.
Item
History of primary hyperaldosteronism.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1384514 (UMLS CUI 2011AA)
190507007 (SNOMED CT 2011_0131)
10036692 (MedDRA 14.1)
E26.01 (ICD-10-CM Version 2010)
255.12 (ICD-9-CM Version 2011)
Acute myocardial infarction, open heart surgery or cerebral event (stroke/ Transitory Ischemic Attack) within the previous 12 months.
Item
Acute myocardial infarction, open heart surgery or cerebral event (stroke/ Transitory Ischemic Attack) within the previous 12 months.
boolean
C0155626 (UMLS CUI 2011AA)
57054005 (SNOMED CT 2011_0131)
10000891 (MedDRA 14.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
C0189745 (UMLS CUI 2011AA)
2598006 (SNOMED CT 2011_0131)
10048935 (MedDRA 14.1)
C0228174 (UMLS CUI 2011AA)
372073000 (SNOMED CT 2011_0131)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
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:
Item
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:
boolean
C1554075 (UMLS CUI 2011AA)
NP (HL7 V3 2006_05)
C0013227 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C1360419 (UMLS CUI 2011AA)
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)
Pre-treatment with gemfibrozil within the last 12 weeks.
Item
Pre-treatment with gemfibrozil within the last 12 weeks.
boolean
C1882440 (UMLS CUI 2011AA)
C0017245 (UMLS CUI 2011AA)
35282000 (SNOMED CT 2011_0131)
MTHU002557 (LOINC Version 232)
Pre-treatment with rifampicin within the last 12 weeks.
Item
Pre-treatment with rifampicin within the last 12 weeks.
boolean
C1882440 (UMLS CUI 2011AA)
C0035608 (UMLS CUI 2011AA)
387159009 (SNOMED CT 2011_0131)
MTHU008474 (LOINC Version 232)
Treatment with thiazolidinediones within the past 3 months.
Item
Treatment with thiazolidinediones within the past 3 months.
boolean
C0039798 (UMLS CUI 2011AA)
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
If statin therapy applicable: Change of medication within the last 4 weeks.
Item
If statin therapy applicable: Change of medication within the last 4 weeks.
boolean
C0750557 (UMLS CUI 2011AA)
C0360714 (UMLS CUI 2011AA)
372912004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1706839 (UMLS CUI 2011AA)
C0580105 (UMLS CUI 2011AA)
182838006 (SNOMED CT 2011_0131)
Has used non-steroidal anti-inflammatory agents including low dose ASA or Cox-2-inhibitors if therapy has been initiated within the last 4 weeks.
Item
Has used non-steroidal anti-inflammatory agents including low dose ASA or Cox-2-inhibitors if therapy has been initiated within the last 4 weeks.
boolean
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0721444 (UMLS CUI 2011AA)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Treatment with any other investigational drug within 4 weeks before trial entry.
Item
Treatment with any other investigational drug within 4 weeks before trial entry.
boolean
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Any elective surgery during study participation.
Item
Any elective surgery during study participation.
boolean
C0206058 (UMLS CUI 2011AA)
274075007 (SNOMED CT 2011_0131)
10058829 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
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.
Item
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.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
History of dehydration, precoma diabeticorum or shock or diabetic ketoacidosis within the past year prior to screening visit.
Item
History of dehydration, precoma diabeticorum or shock or diabetic ketoacidosis within the past year prior to screening visit.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0011175 (UMLS CUI 2011AA)
34095006 (SNOMED CT 2011_0131)
10012174 (MedDRA 14.1)
MTHU020843 (LOINC Version 232)
E86.0 (ICD-10-CM Version 2010)
276.51 (ICD-9-CM Version 2011)
E12258 (CTCAE 1105E)
C0241863 (UMLS CUI 2011AA)
10012641 (MedDRA 14.1)
C1142529 (UMLS CUI 2011AA)
10058705 (MedDRA 14.1)
C0851302 (UMLS CUI 2011AA)
360546002 (SNOMED CT 2011_0131)
10040576 (MedDRA 14.1)
C0011880 (UMLS CUI 2011AA)
420422005 (SNOMED CT 2011_0131)
10012671 (MedDRA 14.1)
250.1 (ICD-9-CM Version 2011)
Acute or scheduled investigation with iodine containing radiopaque material.
Item
Acute or scheduled investigation with iodine containing radiopaque material.
boolean
C0430007 (UMLS CUI 2011AA)
C0021968 (UMLS CUI 2011AA)
325330005 (SNOMED CT 2011_0131)
MTHU009375 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0302587 (UMLS CUI 2011AA)
C0520510 (UMLS CUI 2011AA)
260769002 (SNOMED CT 2011_0131)
MTHU013790 (LOINC Version 232)
MAT (HL7 V3 2006_05)
Uncontrolled unstable angina pectoris.
Item
Uncontrolled unstable angina pectoris.
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm.
Item
Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm.
boolean
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0031046 (UMLS CUI 2011AA)
3238004 (SNOMED CT 2011_0131)
10034484 (MedDRA 14.1)
E10180 (CTCAE 1105E)
C0027059 (UMLS CUI 2011AA)
50920009 (SNOMED CT 2011_0131)
10028606 (MedDRA 14.1)
I51.4 (ICD-10-CM Version 2010)
429.0 (ICD-9-CM Version 2011)
E10157 (CTCAE 1105E)
C0014118 (UMLS CUI 2011AA)
56819008 (SNOMED CT 2011_0131)
10014665 (MedDRA 14.1)
424.90 (ICD-9-CM Version 2011)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
C0003507 (UMLS CUI 2011AA)
60573004 (SNOMED CT 2011_0131)
10002918 (MedDRA 14.1)
C0003486 (UMLS CUI 2011AA)
67362008 (SNOMED CT 2011_0131)
10002882 (MedDRA 14.1)
I71.9 (ICD-10-CM Version 2010)

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