age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Have type 2 diabetes for >= 3 months and <= 5 years based on the disease diagnostic criteria (refer to the World Health Organization's [WHO]Classification of Diabetes).
Item
Have type 2 diabetes for >= 3 months and <= 5 years based on the disease diagnostic criteria (refer to the World Health Organization's [WHO]Classification of Diabetes).
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)
C0679228 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
Are treatment-naive, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones).
Item
Are treatment-naive, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones).
boolean
C0919936 (UMLS CUI 2011AA)
10051259 (MedDRA 14.1)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0359086 (UMLS CUI 2011AA)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
Are able and willing to tolerate a minimum dose of 1500 mg/day or up to 2000 mg/day of metformin.
Item
Are able and willing to tolerate a minimum dose of 1500 mg/day or up to 2000 mg/day of metformin.
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0013220 (UMLS CUI 2011AA)
228432001 (SNOMED CT 2011_0131)
10052804 (MedDRA 14.1)
C1524031 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
Have HbA1c >= 6.5% to <= 9.5%.
Item
Hemoglobin A1c (HbA1c)
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:
Item
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
a)test negative for pregnancy at screening based on a serum pregnancy test, and
Item
a)test negative for pregnancy at screening based on a serum pregnancy test, and
boolean
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
b)agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug, or
Item
b)agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug, or
boolean
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
c)not be breastfeeding.
Item
Not Lactating
boolean
C2826207 (UMLS CUI 2011AA)
Have a stable weight (plus or minus 5%) >= 3 months prior to screening.
Item
Have a stable weight (plus or minus 5%) >= 3 months prior to screening.
boolean
C0005910 (UMLS CUI 2011AA)
Have a body mass index (BMI) between 23 and 45 kg/m2, inclusive.
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Are well-motivated, capable, and willing to:
Item
Are well-motivated, capable, and willing to:
boolean
C0205170 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C0026605 (UMLS CUI 2011AA)
363882003 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
a)perform SMBG testing
Item
a)perform SMBG testing
boolean
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
C0039593 (UMLS CUI 2011AA)
b)learn how to self-inject treatment (LY2189265 or placebo)and
Item
b)learn how to self-inject treatment (LY2189265 or placebo)and
boolean
C0023185 (UMLS CUI 2011AA)
69998004 (SNOMED CT 2011_0131)
C0036588 (UMLS CUI 2011AA)
C1720154 (UMLS CUI 2011AA)
422145002 (SNOMED CT 2011_0131)
C2976495 (UMLS CUI 2011AA)
C0032042 (UMLS CUI 2011AA)
c)maintain a study diary.
Item
c)maintain a study diary.
boolean
C0024501 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0376660 (UMLS CUI 2011AA)
You have type 1 diabetes mellitus
Item
Diabetes Mellitus, Insulin-Dependent
boolean
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
You are being or have been treated with any of the following medications:
Item
You are being or have been treated with any of the following medications:
boolean
CL415147 (UMLS CUI 2011AA)
CL407060 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
a)chronically treated with insulin for the treatment of diabetes in the past, however, a short-term use of > 3 months prior to screening is allowable,
Item
a)chronically treated with insulin for the treatment of diabetes in the past, however, a short-term use of > 3 months prior to screening is allowable,
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
CL433252 (UMLS CUI 2011AA)
b)GLP-1 analogs within 3 months prior to this screening,
Item
b)GLP-1 analogs within 3 months prior to this screening,
boolean
CL430618 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
c)drugs to cause weight loss within 3 months prior to screening,
Item
c)drugs to cause weight loss within 3 months prior to screening,
boolean
C0013227 (UMLS CUI 2011AA)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0043096 (UMLS CUI 2011AA)
89362005 (SNOMED CT 2011_0131)
10047895 (MedDRA 14.1)
MTHU020881 (LOINC Version 232)
783.21 (ICD-9-CM Version 2011)
E12228 (CTCAE 1105E)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
d)thiazolidinediones (TZDs)within 3 months prior to screening,
Item
d)thiazolidinediones (TZDs)within 3 months prior to screening,
boolean
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
e)chronically treated(>= 14 days) an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening,or
Item
e)chronically treated(>= 14 days) an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening,or
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0017710 (UMLS CUI 2011AA)
419933005 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
f)illegal drugs.
Item
Illicit Drugs
boolean
C0086190 (UMLS CUI 2011AA)
77657003 (SNOMED CT 2011_0131)
MTHU035698 (LOINC Version 232)
You have had 1 or more cases of uncontrolled diabetes which required hospitalization in the 6 months prior to screening,
Item
You have had 1 or more cases of uncontrolled diabetes which required hospitalization in the 6 months prior to screening,
boolean
C0860161 (UMLS CUI 2011AA)
10012619 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
You have a problem with your stomach or have chronically taken medication to increase movement in your digestive tract or slow down the emptying of your digestive tract or you have had gastric bypass (bariatric) surgery.
Item
You have a problem with your stomach or have chronically taken medication to increase movement in your digestive tract or slow down the emptying of your digestive tract or you have had gastric bypass (bariatric) surgery.
boolean
C0577027 (UMLS CUI 2011AA)
300306001 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0232459 (UMLS CUI 2011AA)
61578001 (SNOMED CT 2011_0131)
10012980 (MedDRA 14.1)
MTHU013235 (LOINC Version 232)
C0017125 (UMLS CUI 2011AA)
442338001 (SNOMED CT 2011_0131)
10061966 (MedDRA 14.1)
C0038895 (UMLS CUI 2011AA)
C1456587 (UMLS CUI 2011AA)
10068900 (MedDRA 14.1)
You have had problems with your heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion,a heart rhythm problem, or a stroke.
Item
You have had problems with your heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion,a heart rhythm problem, or a stroke.
boolean
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)
C0008031 (UMLS CUI 2011AA)
29857009 (SNOMED CT 2011_0131)
10008479 (MedDRA 14.1)
MTHU035552 (LOINC Version 232)
R07.9 (ICD-10-CM Version 2010)
786.5 (ICD-9-CM Version 2011)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0010055 (UMLS CUI 2011AA)
232717009 (SNOMED CT 2011_0131)
10011077 (MedDRA 14.1)
36.10 (ICD-9-CM Version 2011)
C0190211 (UMLS CUI 2011AA)
41339005 (SNOMED CT 2011_0131)
10050329 (MedDRA 14.1)
C0521232 (UMLS CUI 2011AA)
36969009 (SNOMED CT 2011_0131)
10052086 (MedDRA 14.1)
36.06 (ICD-9-CM Version 2011)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
You have a serum creatinine result which shows a >= 1.5 mg/dL for men or >= 1.4 mg/dL for women.
Item
You have a serum creatinine result which shows a >= 1.5 mg/dL for men or >= 1.4 mg/dL for women.
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
You have a problem with your liver or pancreas.
Item
You have a problem with your liver or pancreas.
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)
C0030286 (UMLS CUI 2011AA)
3855007 (SNOMED CT 2011_0131)
10033616 (MedDRA 14.1)
K86.9 (ICD-10-CM Version 2010)
577.9 (ICD-9-CM Version 2011)
You have creatinine clearance result which shows < 60 mL/minute, evidence of a significant active, uncontrolled endocrine (hormone) or active autoimmune abnormality.
Item
You have creatinine clearance result which shows < 60 mL/minute, evidence of a significant active, uncontrolled endocrine (hormone) or active autoimmune abnormality.
boolean
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0014130 (UMLS CUI 2011AA)
362969004 (SNOMED CT 2011_0131)
10014695 (MedDRA 14.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (ICD-9-CM Version 2011)
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
You have a serum calcitonin test and it shows a >= 20 pcg/mL at the time of screening.
Item
You have a serum calcitonin test and it shows a >= 20 pcg/mL at the time of screening.
boolean
C0863135 (UMLS CUI 2011AA)
271230004 (SNOMED CT 2011_0131)
10040167 (MedDRA 14.1)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
You have or have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
Item
You have or have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1392158 (UMLS CUI 2011AA)
10070569 (MedDRA 14.1)
C0025268 (UMLS CUI 2011AA)
61808009 (SNOMED CT 2011_0131)
10028191 (MedDRA 14.1)
E31.22 (ICD-10-CM Version 2010)
258.02 (ICD-9-CM Version 2011)
C0025269 (UMLS CUI 2011AA)
61530001 (SNOMED CT 2011_0131)
10056420 (MedDRA 14.1)
You have cancer (except for skin cancer) or have been in remission from cancer for < 5 years.
Item
You have cancer (except for skin cancer) or have been in remission from cancer for < 5 years.
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007114 (UMLS CUI 2011AA)
372130007 (SNOMED CT 2011_0131)
10040808 (MedDRA 14.1)
C44.9 (ICD-10-CM Version 2010)
C0687702 (UMLS CUI 2011AA)
10065305 (MedDRA 14.1)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
You have had an organ transplant except for corneal transplant.
Item
You have had an organ transplant except for corneal transplant.
boolean
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0010042 (UMLS CUI 2011AA)
60656008 (SNOMED CT 2011_0131)
10054846 (MedDRA 14.1)
11.60 (ICD-9-CM Version 2011)
You have received treatment within the last 30 days with a drug which has not been regulatory approved.
Item
You have received treatment within the last 30 days with a drug which has not been regulatory approved.
boolean
C0039798 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1704735 (UMLS CUI 2011AA)
C0205540 (UMLS CUI 2011AA)
9571008 (SNOMED CT 2011_0131)
You have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed on you within 30 days prior to screening.
Item
You have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed on you within 30 days prior to screening.
boolean
C0021430 (UMLS CUI 2011AA)
You have any condition that is a contraindication to or would interfere with medications provided for this study to treat your diabetes.
Item
You have any condition that is a contraindication to or would interfere with medications provided for this study to treat your diabetes.
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
You have a blood disorder that would interfere with us drawing blood glucose measurement or lab samples.
Item
You have a blood disorder that would interfere with us drawing blood glucose measurement or lab samples.
boolean
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)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0392201 (UMLS CUI 2011AA)
33747003 (SNOMED CT 2011_0131)
10005553 (MedDRA 14.1)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
CL423120 (UMLS CUI 2011AA)
You have previously participated or signed an informed consent document for this same type of study and study drug.
Item
You have previously participated or signed an informed consent document for this same type of study and study drug.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C2348583 (UMLS CUI 2011AA)
C0445247 (UMLS CUI 2011AA)
262126009 (SNOMED CT 2011_0131)
C0035171 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)