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)
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)