ID

43485

Description

ODM derived from http://clinicaltrials.gov/show/NCT00856284

Link

http://clinicaltrials.gov/show/NCT00856284

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - 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 NCT00856284 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 18 Years to 80 Years
Description

age 18 Years to 80 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Has a diagnosis of type 2 diabetes mellitus.
Description

Has a diagnosis of type 2 diabetes mellitus.

Data type

boolean

Alias
UMLS CUI 1
C0011900
UMLS CUI 1*1
C0011860
Must meet one of the following:
Description

Must meet one of the following:

Data type

boolean

Alias
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
Has been inadequately controlled on a stable daily dose of >= 1500 mg (or documented maximum tolerated dose) of metformin for at least 2 months prior to Screening.
Description

Has been inadequately controlled on a stable daily dose of >= 1500 mg (or documented maximum tolerated dose) of metformin for at least 2 months prior to Screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C2348070
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0752079
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Has been inadequately controlled (as defined by a glycosylated hemoglobin 7.5 10%, inclusive) on metformin <1500 mg without documented maximum tolerated dose.
Description

Has been inadequately controlled (as defined by a glycosylated hemoglobin 7.5 10%, inclusive) on metformin <1500 mg without documented maximum tolerated dose.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0017853
SNOMED CT 2011_0131
259689004
LOINC Version 232
MTHU020323
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0752079
No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B).
Description

No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B).

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Has body mass index within 23kg/m2 and 45kg/m2 unless the subject is Asian or of Asian descent, for whom the allowable body mass index will be >= 20 kg/m2 and <= 35 kg/m2, inclusive.
Description

Has body mass index within 23kg/m2 and 45kg/m2 unless the subject is Asian or of Asian descent, for whom the allowable body mass index will be >= 20 kg/m2 and <= 35 kg/m2, inclusive.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0078988
SNOMED CT 2011_0131
413582008
HL7 V3 2006_05
2028-9
UMLS CUI 2011AA
C0680043
Has fasting C-peptide concentration at least 0.8 ng.
Description

Has fasting C-peptide concentration at least 0.8 ng.

Data type

boolean

Alias
UMLS CUI 2011AA
C0015663
HL7 V3 2006_05
FAST
UMLS CUI 2011AA
C0006558
SNOMED CT 2011_0131
39973008
LOINC Version 232
MTHU003747
UMLS CUI 2011AA
C1446561
If regularly using non-excluded medications, must be on a stable dose at least 4 wks prior to Screening/Pre-screening.
Description

If regularly using non-excluded medications, must be on a stable dose at least 4 wks prior to Screening/Pre-screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant, lactating or intends to donate ova 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, lactating or intends to donate ova 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
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
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
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0242812
Must be able and willing to monitor their blood glucose concentrations with a home monitor, and comply with protocol requirements including scheduled clinic appointments.
Description

Must be able and willing to monitor their blood glucose concentrations with a home monitor, and comply with protocol requirements including scheduled clinic appointments.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
CL415337
UMLS CUI 2011AA
C2585282
SNOMED CT 2011_0131
434912009
UMLS CUI 2011AA
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Systolic blood pressure >= 150 mmHg and/or diastolic pressure >= 90.
Description

Systolic blood pressure >= 150 mmHg and/or diastolic pressure >= 90.

Data type

boolean

Alias
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
Hemoglobin <= 12 g/dL for males and <= 10 g/dL for females at Screening Visit.
Description

Hemoglobin <= 12 g/dL for males and <= 10 g/dL for females at Screening Visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
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
C1409616
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Alanine aminotransferase >= 2.5 times the upper limit of normal at Screening Visit.
Description

Alanine aminotransferase >= 2.5 times the upper limit of normal at Screening Visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Serum creatinine >= 1.5 mg/dL for males and 1.4 for females, or calculated creatinine clearance < 60 L/min.
Description

Serum creatinine >= 1.5 mg/dL for males and 1.4 for females, or calculated creatinine clearance < 60 L/min.

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
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
C0444686
SNOMED CT 2011_0131
258090004
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
Males intending to impregnate others or donate sperm before, during or within 1 month after participating in the study.
Description

Males intending to impregnate others or donate sperm before, during or within 1 month after participating in the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0162425
UMLS CUI 2011AA
C0015914
SNOMED CT 2011_0131
55767001
MedDRA 14.1
10016473
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0871414
MedDRA 14.1
10053369
A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 yrs.
Description

A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 yrs.

Data type

boolean

Alias
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
A history of laser treatment for diabetic retinopathy within 6 months of screening.
Description

A history of laser treatment for diabetic retinopathy within 6 months of screening.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
CL382917
UMLS CUI 2011AA
C0011884
SNOMED CT 2011_0131
4855003
MedDRA 14.1
10012689
LOINC Version 232
MTHU020818
ICD-9-CM Version 2011
362.0
Treated for diabetic gastric paresis, gastric banding, or gastric bypass.
Description

Treated for diabetic gastric paresis, gastric banding, or gastric bypass.

Data type

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0267176
SNOMED CT 2011_0131
34140002
MedDRA 14.1
10051153
UMLS CUI 2011AA
C1960832
MedDRA 14.1
10060785
UMLS CUI 2011AA
C0017125
SNOMED CT 2011_0131
442338001
MedDRA 14.1
10061966
New York Heart Association Class III or IV heart failure.
Description

New York Heart Association Class III or IV heart failure.

Data type

boolean

Alias
UMLS CUI 2011AA
C1275491
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening.
Description

History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0190211
SNOMED CT 2011_0131
41339005
MedDRA 14.1
10050329
UMLS CUI 2011AA
C0948884
MedDRA 14.1
10052597
UMLS CUI 2011AA
C0010055
SNOMED CT 2011_0131
232717009
MedDRA 14.1
10011077
ICD-9-CM Version 2011
36.10
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
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
Known history of human immunodeficiency virus, hepatitis B or C.
Description

Known history of human immunodeficiency virus, hepatitis B or C.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
UMLS CUI 2011AA
C1997078
SNOMED CT 2011_0131
429721005
Alcohol or substance abuse within 2 years prior to screening.
Description

Alcohol or substance abuse within 2 years prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
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
C0013227
UMLS CUI 2011AA
C0242388
SNOMED CT 2011_0131
414392008
MedDRA 14.1
10063339
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
Any investigational drug within 30 days
Description

Any investigational drug within 30 days

Data type

boolean

Alias
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Any investigational diabetic drug within 3 months
Description

Any investigational diabetic drug within 3 months

Data type

boolean

Alias
UMLS CUI 2011AA
C1517586
UMLS CUI 2011AA
C0241863
MedDRA 14.1
10012641
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening other than metformin
Description

Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening other than metformin

Data type

boolean

Alias
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
C1827106
SNOMED CT 2011_0131
423837000
UMLS CUI 2011AA
CL430618
UMLS CUI 2011AA
C0456387
SNOMED CT 2011_0131
277046005
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
Prior treatment with alogliptin.
Description

Prior treatment with alogliptin.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1958126
Weight-Loss Agents
Description

Weight-loss drugs

Data type

boolean

Alias
UMLS CUI 2011AA
C0376606
Investigational antidiabetics
Description

Investigational antidiabetics

Data type

boolean

Alias
UMLS CUI 2011AA
C1517586
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
Oral or systemically injected glucocorticoids
Description

Oral or systemically injected glucocorticoids

Data type

boolean

Alias
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
UMLS CUI 2011AA
C0017710
SNOMED CT 2011_0131
419933005
A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide.
Description

A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide.

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0002792
SNOMED CT 2011_0131
39579001
MedDRA 14.1
10002199
ICD-10-CM Version 2010
T78.2
CTCAE 1105E
E11254
UMLS CUI 2011AA
C0081937
SNOMED CT 2011_0131
62412007
LOINC Version 232
MTHU007379
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0017642
SNOMED CT 2011_0131
387143009
LOINC Version 232
MTHU001811
Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).
Description

Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).

Data type

boolean

Alias
UMLS CUI 2011AA
C0040128
SNOMED CT 2011_0131
14304000
MedDRA 14.1
10043709
ICD-10-CM Version 2010
E00-E07
ICD-9-CM Version 2011
240-246.99
UMLS CUI 2011AA
C0178468
UMLS CUI 2011AA
C0018213
SNOMED CT 2011_0131
353295004
MedDRA 14.1
10018706
ICD-10-CM Version 2010
E05.0
UMLS CUI 2011AA
C0677607
SNOMED CT 2011_0131
21983002
MedDRA 14.1
10019167
ICD-10-CM Version 2010
E06.3
ICD-9-CM Version 2011
245.2
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0040137
SNOMED CT 2011_0131
237495005
MedDRA 14.1
10043751
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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 80 Years
Item
age 18 Years to 80 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Has a diagnosis of type 2 diabetes mellitus.
Item
Has a diagnosis of type 2 diabetes mellitus.
boolean
C0011900 (UMLS CUI 1)
C0011860 (UMLS CUI 1*1)
Must meet one of the following:
Item
Must meet one of the following:
boolean
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
Has been inadequately controlled on a stable daily dose of >= 1500 mg (or documented maximum tolerated dose) of metformin for at least 2 months prior to Screening.
Item
Has been inadequately controlled on a stable daily dose of >= 1500 mg (or documented maximum tolerated dose) of metformin for at least 2 months prior to Screening.
boolean
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C2348070 (UMLS CUI 2011AA)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0752079 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Has been inadequately controlled (as defined by a glycosylated hemoglobin 7.5 10%, inclusive) on metformin <1500 mg without documented maximum tolerated dose.
Item
Has been inadequately controlled (as defined by a glycosylated hemoglobin 7.5 10%, inclusive) on metformin <1500 mg without documented maximum tolerated dose.
boolean
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0017853 (UMLS CUI 2011AA)
259689004 (SNOMED CT 2011_0131)
MTHU020323 (LOINC Version 232)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0752079 (UMLS CUI 2011AA)
No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B).
Item
No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B).
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Has body mass index within 23kg/m2 and 45kg/m2 unless the subject is Asian or of Asian descent, for whom the allowable body mass index will be >= 20 kg/m2 and <= 35 kg/m2, inclusive.
Item
Has body mass index within 23kg/m2 and 45kg/m2 unless the subject is Asian or of Asian descent, for whom the allowable body mass index will be >= 20 kg/m2 and <= 35 kg/m2, inclusive.
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0078988 (UMLS CUI 2011AA)
413582008 (SNOMED CT 2011_0131)
2028-9 (HL7 V3 2006_05)
C0680043 (UMLS CUI 2011AA)
Has fasting C-peptide concentration at least 0.8 ng.
Item
Has fasting C-peptide concentration at least 0.8 ng.
boolean
C0015663 (UMLS CUI 2011AA)
FAST (HL7 V3 2006_05)
C0006558 (UMLS CUI 2011AA)
39973008 (SNOMED CT 2011_0131)
MTHU003747 (LOINC Version 232)
C1446561 (UMLS CUI 2011AA)
If regularly using non-excluded medications, must be on a stable dose at least 4 wks prior to Screening/Pre-screening.
Item
If regularly using non-excluded medications, must be on a stable dose at least 4 wks prior to Screening/Pre-screening.
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant, lactating or intends to donate ova 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, lactating or intends to donate ova 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)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
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)
C1518422 (UMLS CUI 2011AA)
C0242812 (UMLS CUI 2011AA)
Must be able and willing to monitor their blood glucose concentrations with a home monitor, and comply with protocol requirements including scheduled clinic appointments.
Item
Must be able and willing to monitor their blood glucose concentrations with a home monitor, and comply with protocol requirements including scheduled clinic appointments.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
CL415337 (UMLS CUI 2011AA)
C2585282 (UMLS CUI 2011AA)
434912009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Systolic blood pressure >= 150 mmHg and/or diastolic pressure >= 90.
Item
Systolic blood pressure >= 150 mmHg and/or diastolic pressure >= 90.
boolean
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
Hemoglobin <= 12 g/dL for males and <= 10 g/dL for females at Screening Visit.
Item
Hemoglobin <= 12 g/dL for males and <= 10 g/dL for females at Screening Visit.
boolean
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
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)
C1409616 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Alanine aminotransferase >= 2.5 times the upper limit of normal at Screening Visit.
Item
Alanine aminotransferase >= 2.5 times the upper limit of normal at Screening Visit.
boolean
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1409616 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Serum creatinine >= 1.5 mg/dL for males and 1.4 for females, or calculated creatinine clearance < 60 L/min.
Item
Serum creatinine >= 1.5 mg/dL for males and 1.4 for females, or calculated creatinine clearance < 60 L/min.
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
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)
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Males intending to impregnate others or donate sperm before, during or within 1 month after participating in the study.
Item
Males intending to impregnate others or donate sperm before, during or within 1 month after participating in the study.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0162425 (UMLS CUI 2011AA)
C0015914 (UMLS CUI 2011AA)
55767001 (SNOMED CT 2011_0131)
10016473 (MedDRA 14.1)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0871414 (UMLS CUI 2011AA)
10053369 (MedDRA 14.1)
A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 yrs.
Item
A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 yrs.
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C1518422 (UMLS CUI 2011AA)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
A history of laser treatment for diabetic retinopathy within 6 months of screening.
Item
A history of laser treatment for diabetic retinopathy within 6 months of screening.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
CL382917 (UMLS CUI 2011AA)
C0011884 (UMLS CUI 2011AA)
4855003 (SNOMED CT 2011_0131)
10012689 (MedDRA 14.1)
MTHU020818 (LOINC Version 232)
362.0 (ICD-9-CM Version 2011)
Treated for diabetic gastric paresis, gastric banding, or gastric bypass.
Item
Treated for diabetic gastric paresis, gastric banding, or gastric bypass.
boolean
CL415147 (UMLS CUI 2011AA)
C0267176 (UMLS CUI 2011AA)
34140002 (SNOMED CT 2011_0131)
10051153 (MedDRA 14.1)
C1960832 (UMLS CUI 2011AA)
10060785 (MedDRA 14.1)
C0017125 (UMLS CUI 2011AA)
442338001 (SNOMED CT 2011_0131)
10061966 (MedDRA 14.1)
New York Heart Association Class III or IV heart failure.
Item
New York Heart Association Class III or IV heart failure.
boolean
C1275491 (UMLS CUI 2011AA)
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening.
Item
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0190211 (UMLS CUI 2011AA)
41339005 (SNOMED CT 2011_0131)
10050329 (MedDRA 14.1)
C0948884 (UMLS CUI 2011AA)
10052597 (MedDRA 14.1)
C0010055 (UMLS CUI 2011AA)
232717009 (SNOMED CT 2011_0131)
10011077 (MedDRA 14.1)
36.10 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
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)
Known history of human immunodeficiency virus, hepatitis B or C.
Item
Known history of human immunodeficiency virus, hepatitis B or C.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
C1997078 (UMLS CUI 2011AA)
429721005 (SNOMED CT 2011_0131)
Alcohol or substance abuse within 2 years prior to screening.
Item
Alcohol or substance abuse within 2 years prior to screening.
boolean
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
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)
C0013227 (UMLS CUI 2011AA)
C0242388 (UMLS CUI 2011AA)
414392008 (SNOMED CT 2011_0131)
10063339 (MedDRA 14.1)
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)
Any investigational drug within 30 days
Item
Any investigational drug within 30 days
boolean
C0013230 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Any investigational diabetic drug within 3 months
Item
Any investigational diabetic drug within 3 months
boolean
C1517586 (UMLS CUI 2011AA)
C0241863 (UMLS CUI 2011AA)
10012641 (MedDRA 14.1)
C0013227 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening other than metformin
Item
Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening other than metformin
boolean
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C1827106 (UMLS CUI 2011AA)
423837000 (SNOMED CT 2011_0131)
CL430618 (UMLS CUI 2011AA)
C0456387 (UMLS CUI 2011AA)
277046005 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
Prior treatment with alogliptin.
Item
Prior treatment with alogliptin.
boolean
C1514463 (UMLS CUI 2011AA)
C1958126 (UMLS CUI 2011AA)
Weight-loss drugs
Item
Weight-Loss Agents
boolean
C0376606 (UMLS CUI 2011AA)
Investigational antidiabetics
Item
Investigational antidiabetics
boolean
C1517586 (UMLS CUI 2011AA)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
Oral or systemically injected glucocorticoids
Item
Oral or systemically injected glucocorticoids
boolean
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0017710 (UMLS CUI 2011AA)
419933005 (SNOMED CT 2011_0131)
A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide.
Item
A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide.
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0002792 (UMLS CUI 2011AA)
39579001 (SNOMED CT 2011_0131)
10002199 (MedDRA 14.1)
T78.2 (ICD-10-CM Version 2010)
E11254 (CTCAE 1105E)
C0081937 (UMLS CUI 2011AA)
62412007 (SNOMED CT 2011_0131)
MTHU007379 (LOINC Version 232)
C0013227 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0017642 (UMLS CUI 2011AA)
387143009 (SNOMED CT 2011_0131)
MTHU001811 (LOINC Version 232)
Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).
Item
Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).
boolean
C0040128 (UMLS CUI 2011AA)
14304000 (SNOMED CT 2011_0131)
10043709 (MedDRA 14.1)
E00-E07 (ICD-10-CM Version 2010)
240-246.99 (ICD-9-CM Version 2011)
C0178468 (UMLS CUI 2011AA)
C0018213 (UMLS CUI 2011AA)
353295004 (SNOMED CT 2011_0131)
10018706 (MedDRA 14.1)
E05.0 (ICD-10-CM Version 2010)
C0677607 (UMLS CUI 2011AA)
21983002 (SNOMED CT 2011_0131)
10019167 (MedDRA 14.1)
E06.3 (ICD-10-CM Version 2010)
245.2 (ICD-9-CM Version 2011)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0040137 (UMLS CUI 2011AA)
237495005 (SNOMED CT 2011_0131)
10043751 (MedDRA 14.1)
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