ID

4376

Description

ODM derived from http://clinicaltrials.gov/show/NCT00960661

Link

http://clinicaltrials.gov/show/NCT00960661

Keywords

Versions (1)
  1. 12/7/13 12/7/13 - Martin Dugas
Uploaded on

December 7, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00960661 Type 2 Diabetes Mellitus

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Type 2 Diabetes Mellitus
Description

Type 2 Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Have been taking a basal insulin Glargine, at dose of >= 20 units/day, for at least 3 months prior to study start.
Description

Have been taking a basal insulin Glargine, at dose of >= 20 units/day, for at least 3 months prior to study start.

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0205112
SNOMED CT 2011_0131
57195005
UMLS CUI 2011AA
C0907402
SNOMED CT 2011_0131
411529005
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
Have been taking basal insulin Glargine at dose of >= 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
Description

Have been taking basal insulin Glargine at dose of >= 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0205112
SNOMED CT 2011_0131
57195005
UMLS CUI 2011AA
C0907402
SNOMED CT 2011_0131
411529005
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
Description

Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no < 500 mg/day for at least 6 weeks prior to study start, or

Data type

boolean

Alias
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C1708470
UMLS CUI 2011AA
C1707968
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no < 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
Description

Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no < 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.

Data type

boolean

Alias
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C1708470
UMLS CUI 2011AA
C1707968
UMLS CUI 2011AA
C1550557
HL7 V3 2006_05
AND
UMLS CUI 2011AA
C0038766
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
Hemoglobin A1c (HbA1c)
Description

Have an HbA1C > 7.0% and <= 10.0%.

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
Body mass index
Description

Have a body mass index (BMI) between >= 25 and <= 45 kg/m2.

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
Description

Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
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
C1518422
UMLS CUI 2011AA
C1552738
HL7 V3 2006_05
KIND
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C1554075
HL7 V3 2006_05
NP
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
Description

Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C0017725
SNOMED CT 2011_0131
67079006
LOINC Version 232
MTHU001675
UMLS CUI 2011AA
C2003888
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0376606
UMLS CUI 2011AA
C0732649
SNOMED CT 2011_0131
387007000
UMLS CUI 2011AA
C0074493
SNOMED CT 2011_0131
386838007
LOINC Version 232
MTHU035870
UMLS CUI 2011AA
C0031495
SNOMED CT 2011_0131
387464001
LOINC Version 232
MTHU005032
UMLS CUI 2011AA
C1142933
SNOMED CT 2011_0131
422794008
Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
Description

Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0907402
SNOMED CT 2011_0131
411529005
Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
Description

Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.

Data type

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
C0017710
SNOMED CT 2011_0131
419933005
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0360289
SNOMED CT 2011_0131
350088003
UMLS CUI 2011AA
CL429484
UMLS CUI 2011AA
CL426883
UMLS CUI 2011AA
C0013227
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Description

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

Data type

boolean

Alias
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1096117
MedDRA 14.1
10053762
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C0079816
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1524057
SNOMED CT 2011_0131
7883008
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Have previously completed or been withdrawn from this study after enrollment.
Description

Have previously completed or been withdrawn from this study after enrollment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1556116
HL7 V3 2006_05
completed
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0422727
SNOMED CT 2011_0131
185924006
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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 at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Type 2 Diabetes Mellitus
Item
Type 2 Diabetes Mellitus
boolean
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Have been taking a basal insulin Glargine, at dose of >= 20 units/day, for at least 3 months prior to study start.
Item
Have been taking a basal insulin Glargine, at dose of >= 20 units/day, for at least 3 months prior to study start.
boolean
C1512806 (UMLS CUI 2011AA)
C0205112 (UMLS CUI 2011AA)
57195005 (SNOMED CT 2011_0131)
C0907402 (UMLS CUI 2011AA)
411529005 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Have been taking basal insulin Glargine at dose of >= 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
Item
Have been taking basal insulin Glargine at dose of >= 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
boolean
C1512806 (UMLS CUI 2011AA)
C0205112 (UMLS CUI 2011AA)
57195005 (SNOMED CT 2011_0131)
C0907402 (UMLS CUI 2011AA)
411529005 (SNOMED CT 2011_0131)
C1947911 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no < 500 mg/day for at least 6 weeks prior to study start, or
Item
boolean
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C1708470 (UMLS CUI 2011AA)
C1707968 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no < 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
Item
Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no < 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
boolean
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C1708470 (UMLS CUI 2011AA)
C1707968 (UMLS CUI 2011AA)
C1550557 (UMLS CUI 2011AA)
AND (HL7 V3 2006_05)
C0038766 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
Have an HbA1C > 7.0% and <= 10.0%.
Item
Hemoglobin A1c (HbA1c)
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Have a body mass index (BMI) between >= 25 and <= 45 kg/m2.
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
Item
Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
boolean
C1512806 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1552738 (UMLS CUI 2011AA)
KIND (HL7 V3 2006_05)
CL384738 (UMLS CUI 2011AA)
C1554075 (UMLS CUI 2011AA)
NP (HL7 V3 2006_05)
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
Item
Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
boolean
C1512806 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
CL384738 (UMLS CUI 2011AA)
C0017725 (UMLS CUI 2011AA)
67079006 (SNOMED CT 2011_0131)
MTHU001675 (LOINC Version 232)
C2003888 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0376606 (UMLS CUI 2011AA)
C0732649 (UMLS CUI 2011AA)
387007000 (SNOMED CT 2011_0131)
C0074493 (UMLS CUI 2011AA)
386838007 (SNOMED CT 2011_0131)
MTHU035870 (LOINC Version 232)
C0031495 (UMLS CUI 2011AA)
387464001 (SNOMED CT 2011_0131)
MTHU005032 (LOINC Version 232)
C1142933 (UMLS CUI 2011AA)
422794008 (SNOMED CT 2011_0131)
Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
Item
Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
boolean
C1512806 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0907402 (UMLS CUI 2011AA)
411529005 (SNOMED CT 2011_0131)
Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
Item
Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
boolean
C1514756 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0017710 (UMLS CUI 2011AA)
419933005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0360289 (UMLS CUI 2011AA)
350088003 (SNOMED CT 2011_0131)
CL429484 (UMLS CUI 2011AA)
CL426883 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Item
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
boolean
C1516879 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1096117 (UMLS CUI 2011AA)
10053762 (MedDRA 14.1)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C0079816 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1524057 (UMLS CUI 2011AA)
7883008 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Have previously completed or been withdrawn from this study after enrollment.
Item
Have previously completed or been withdrawn from this study after enrollment.
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0422727 (UMLS CUI 2011AA)
185924006 (SNOMED CT 2011_0131)
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