ID

43520

Description

ODM derived from http://clinicaltrials.gov/show/NCT00974740

Link

http://clinicaltrials.gov/show/NCT00974740

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - 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 NCT00974740 Type 1 Diabetes

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 39 Years
Description

age 18 Years to 39 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment
Description

Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0455628
SNOMED CT 2011_0131
161649006
UMLS CUI 2011AA
C1518321
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C1705019
UMLS CUI 2011AA
CL414621
Male patient or female patient using adequate contraceptive methods
Description

Male patient or female patient using adequate contraceptive methods

Data type

boolean

Alias
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
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA
Description

Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA

Data type

boolean

Alias
UMLS CUI 2011AA
C1335447
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0004358
SNOMED CT 2011_0131
30621004
LOINC Version 232
MTHU031562
UMLS CUI 2011AA
C1414926
UMLS CUI 2011AA
C1419119
UMLS CUI 2011AA
C0201519
SNOMED CT 2011_0131
64135003
MedDRA 14.1
10050516
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
History of neoplastic disease
Description

History of a malignancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0006826
Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated > ten percent above the upper limit of normal, elevation of AST or ALT > 3 times the upper limit of normal
Description

Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated > ten percent above the upper limit of normal, elevation of AST or ALT > 3 times the upper limit of normal

Data type

boolean

Alias
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
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
CL414623
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator
Description

Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0521982
SNOMED CT 2011_0131
182985004
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0205217
HL7 V3 2006_05
U
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin
Description

Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
UMLS CUI 2011AA
C0005525
UMLS CUI 2011AA
C0003364
SNOMED CT 2011_0131
372586001
UMLS CUI 2011AA
C0086440
SNOMED CT 2011_0131
57952007
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
Pregnant or nursing women or women intending to become pregnant
Description

Pregnant or nursing women or women intending to become pregnant

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
Known or suspected allergy to atorvastatin or any component of the trial product
Description

Known or suspected allergy to atorvastatin or any component of the trial product

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0286651
SNOMED CT 2011_0131
373444002
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Known myopathy, myalgia or myositis with a serum-CPK > 3 times the upper limit of normal
Description

Known myopathy, myalgia or myositis with a serum-CPK > 3 times the upper limit of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C0026848
SNOMED CT 2011_0131
129565002
MedDRA 14.1
10028641
ICD-10-CM Version 2010
G72.9
ICD-9-CM Version 2011
359.9
UMLS CUI 2011AA
C0231528
SNOMED CT 2011_0131
68962001
MedDRA 14.1
10028323
LOINC Version 232
MTHU013523
ICD-10-CM Version 2010
M79.1
CTCAE 1105E
E12485
UMLS CUI 2011AA
C0027121
SNOMED CT 2011_0131
26889001
MedDRA 14.1
10028653
ICD-10-CM Version 2010
M60.9
CTCAE 1105E
E12489
UMLS CUI 2011AA
C0750860
MedDRA 14.1
10040222
UMLS CUI 2011AA
C1519815
Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2
Description

Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
CL353706
UMLS CUI 2011AA
C0005794
SNOMED CT 2011_0131
25179006
Any significant laboratory abnormality
Description

Any significant laboratory abnormality

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
A serum LDL-cholesterol > 150 mg/dL at time of screening
Description

A serum LDL-cholesterol > 150 mg/dL at time of screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0428474
SNOMED CT 2011_0131
166833005
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C1409616
Unwillingness to comply with study procedures
Description

Unwillingness to comply with study procedures

Data type

boolean

Alias
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0680734
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 39 Years
Item
age 18 Years to 39 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment
Item
Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment
boolean
C0455628 (UMLS CUI 2011AA)
161649006 (SNOMED CT 2011_0131)
C1518321 (UMLS CUI 2011AA)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1704788 (UMLS CUI 2011AA)
C1705019 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
Male patient or female patient using adequate contraceptive methods
Item
Male patient or female patient using adequate contraceptive methods
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA
Item
Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA
boolean
C1335447 (UMLS CUI 2011AA)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0004358 (UMLS CUI 2011AA)
30621004 (SNOMED CT 2011_0131)
MTHU031562 (LOINC Version 232)
C1414926 (UMLS CUI 2011AA)
C1419119 (UMLS CUI 2011AA)
C0201519 (UMLS CUI 2011AA)
64135003 (SNOMED CT 2011_0131)
10050516 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
History of a malignancy
Item
History of neoplastic disease
boolean
C0006826 (UMLS CUI 2011AA)
Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated > ten percent above the upper limit of normal, elevation of AST or ALT > 3 times the upper limit of normal
Item
Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated > ten percent above the upper limit of normal, elevation of AST or ALT > 3 times the upper limit of normal
boolean
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)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
CL414623 (UMLS CUI 2011AA)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator
Item
Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0521982 (UMLS CUI 2011AA)
182985004 (SNOMED CT 2011_0131)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin
Item
Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0005525 (UMLS CUI 2011AA)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
C0086440 (UMLS CUI 2011AA)
57952007 (SNOMED CT 2011_0131)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
Pregnant or nursing women or women intending to become pregnant
Item
Pregnant or nursing women or women intending to become pregnant
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
Known or suspected allergy to atorvastatin or any component of the trial product
Item
Known or suspected allergy to atorvastatin or any component of the trial product
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0286651 (UMLS CUI 2011AA)
373444002 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Known myopathy, myalgia or myositis with a serum-CPK > 3 times the upper limit of normal
Item
Known myopathy, myalgia or myositis with a serum-CPK > 3 times the upper limit of normal
boolean
C0026848 (UMLS CUI 2011AA)
129565002 (SNOMED CT 2011_0131)
10028641 (MedDRA 14.1)
G72.9 (ICD-10-CM Version 2010)
359.9 (ICD-9-CM Version 2011)
C0231528 (UMLS CUI 2011AA)
68962001 (SNOMED CT 2011_0131)
10028323 (MedDRA 14.1)
MTHU013523 (LOINC Version 232)
M79.1 (ICD-10-CM Version 2010)
E12485 (CTCAE 1105E)
C0027121 (UMLS CUI 2011AA)
26889001 (SNOMED CT 2011_0131)
10028653 (MedDRA 14.1)
M60.9 (ICD-10-CM Version 2010)
E12489 (CTCAE 1105E)
C0750860 (UMLS CUI 2011AA)
10040222 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2
Item
Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
CL353706 (UMLS CUI 2011AA)
C0005794 (UMLS CUI 2011AA)
25179006 (SNOMED CT 2011_0131)
Any significant laboratory abnormality
Item
Any significant laboratory abnormality
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
A serum LDL-cholesterol > 150 mg/dL at time of screening
Item
A serum LDL-cholesterol > 150 mg/dL at time of screening
boolean
C0428474 (UMLS CUI 2011AA)
166833005 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Unwillingness to comply with study procedures
Item
Unwillingness to comply with study procedures
boolean
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0680734 (UMLS CUI 2011AA)
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