age 18 Years to 70 Years
Item
age 18 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria
Item
Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
C0679228 (UMLS CUI 2011AA)
Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
Item
Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
CL420107 (UMLS CUI 2011AA)
C0015787 (UMLS CUI 2011AA)
169549004 (SNOMED CT 2011_0131)
10056199 (MedDRA 14.1)
C0020699 (UMLS CUI 2011AA)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
C0278321 (UMLS CUI 2011AA)
76876009 (SNOMED CT 2011_0131)
10030339 (MedDRA 14.1)
65.51 (ICD-9-CM Version 2011)
C0520483 (UMLS CUI 2011AA)
77543007 (SNOMED CT 2011_0131)
10044722 (MedDRA 14.1)
C0025320 (UMLS CUI 2011AA)
161712005 (SNOMED CT 2011_0131)
10027308 (MedDRA 14.1)
E13750 (CTCAE 1105E)
Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.
Item
Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 mg/day.
Item
Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 mg/day.
boolean
C0556895 (UMLS CUI 2011AA)
229554006 (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)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
Have an HbA1c value of 7.0% to 10.5% , inclusive.
Item
Have an HbA1c value of 7.0% to 10.5% , inclusive.
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
Have a body mass index (BMI) between 25 to 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)
In the opinion of the investigator, are capable and willing to:
Item
In the opinion of the investigator, are capable and willing to:
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C2698977 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
Perform self-monitoring of blood glucose
Item
Perform self-monitoring of blood glucose
boolean
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
Complete a study diary as required for this protocol
Item
Complete a study diary as required for this protocol
boolean
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0376660 (UMLS CUI 2011AA)
C1709747 (UMLS CUI 2011AA)
Maintain consistent dietary, physical activity, and sleeping patterns throughout the duration of the study
Item
Maintain consistent dietary, physical activity, and sleeping patterns throughout the duration of the study
boolean
C0024501 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0026606 (UMLS CUI 2011AA)
68130003 (SNOMED CT 2011_0131)
MTHU017278 (LOINC Version 232)
C0474396 (UMLS CUI 2011AA)
401175000, 404950004 (SNOMED CT 2011_0131)
Comply with treatment regimens
Item
Comply with treatment regimens
boolean
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site.
Item
Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site.
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL415116 (UMLS CUI 2011AA)
C0851285 (UMLS CUI 2011AA)
C0086265 (UMLS CUI 2011AA)
C1948070 (UMLS CUI 2011AA)
Have > 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.
Item
Have > 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.
boolean
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0007004 (UMLS CUI 2011AA)
350544001 (SNOMED CT 2011_0131)
MTHU006866 (LOINC Version 232)
C0017687 (UMLS CUI 2011AA)
10712001 (SNOMED CT 2011_0131)
MTHU005175 (LOINC Version 232)
C0035273 (UMLS CUI 2011AA)
439569004 (SNOMED CT 2011_0131)
10038749 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0853088 (UMLS CUI 2011AA)
10020997 (MedDRA 14.1)
Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
Item
Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
boolean
C1546435 (UMLS CUI 2011AA)
ER (HL7 V3 2006_05)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C2700379 (UMLS CUI 2011AA)
C0726398 (UMLS CUI 2011AA)
Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.
Item
Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.
boolean
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C1280500 (UMLS CUI 2011AA)
253861007 (SNOMED CT 2011_0131)
C0017127 (UMLS CUI 2011AA)
C0232572 (UMLS CUI 2011AA)
36735000 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0017125 (UMLS CUI 2011AA)
442338001 (SNOMED CT 2011_0131)
10061966 (MedDRA 14.1)
C1261985 (UMLS CUI 2011AA)
10060785 (MedDRA 14.1)
C0038895 (UMLS CUI 2011AA)
Have had a previous diagnosis of pancreatitis.
Item
Have had a previous diagnosis of pancreatitis.
boolean
C0332132 (UMLS CUI 2011AA)
48318009 (SNOMED CT 2011_0131)
C0030305 (UMLS CUI 2011AA)
75694006 (SNOMED CT 2011_0131)
10033645 (MedDRA 14.1)
K85.9 (ICD-10-CM Version 2010)
577.0 (ICD-9-CM Version 2011)
E10930 (CTCAE 1105E)
Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
Item
Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
boolean
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (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)
Have a history of myocardial infarction, unstable angina, or a coronary revascularization procedure within 6 months of screening.
Item
Have a history of myocardial infarction, unstable angina, or a coronary revascularization procedure within 6 months of screening.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
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)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0877341 (UMLS CUI 2011AA)
10049887 (MedDRA 14.1)
Have a history of supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia.
Item
Have a history of supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0039240 (UMLS CUI 2011AA)
6456007 (SNOMED CT 2011_0131)
10042604 (MedDRA 14.1)
I47.1 (ICD-10-CM Version 2010)
E10218 (CTCAE 1105E)
C0042514 (UMLS CUI 2011AA)
25569003 (SNOMED CT 2011_0131)
10047302 (MedDRA 14.1)
I47.2 (ICD-10-CM Version 2010)
E10239 (CTCAE 1105E)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
Have a history of transient ischemic attack (TIA) or stroke within 6 months of screening.
Item
Have a history of transient ischemic attack (TIA) or stroke within 6 months of screening.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
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)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
Have poorly controlled hypertension (systolic blood pressure >= 150 mm Hg or diastolic blood pressure >= 90 mm Hg) as determined by the mean of three separate measurements.
Item
Have poorly controlled hypertension (systolic blood pressure >= 150 mm Hg or diastolic blood pressure >= 90 mm Hg) as determined by the mean of three separate measurements.
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0242485 (UMLS CUI 2011AA)
122869004 (SNOMED CT 2011_0131)
MTHU003137 (LOINC Version 232)
Show evidence of labile blood pressure, including symptomatic postural hypotension.
Item
Show evidence of labile blood pressure, including symptomatic postural hypotension.
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0428895 (UMLS CUI 2011AA)
251080003 (SNOMED CT 2011_0131)
10023533 (MedDRA 14.1)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0020651 (UMLS CUI 2011AA)
28651003 (SNOMED CT 2011_0131)
10031127 (MedDRA 14.1)
I95.1 (ICD-10-CM Version 2010)
458.0 (ICD-9-CM Version 2011)
Have any abnormality of the ECG that would impact patient safety or data interpretation.
Item
Have any abnormality of the ECG that would impact patient safety or data interpretation.
boolean
C0522055 (UMLS CUI 2011AA)
102594003 (SNOMED CT 2011_0131)
10014363 (MedDRA 14.1)
C1280500 (UMLS CUI 2011AA)
253861007 (SNOMED CT 2011_0131)
C1113679 (UMLS CUI 2011AA)
C1511726 (UMLS CUI 2011AA)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
Show clinical signs or symptoms of liver disease, or liver function tests (LFTs, aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening.
Item
Show clinical signs or symptoms of liver disease, or liver function tests (LFTs, aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening.
boolean
C0037088 (UMLS CUI 2011AA)
404684003 (SNOMED CT 2011_0131)
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)
C0877359 (UMLS CUI 2011AA)
10048557 (MedDRA 14.1)
C2825579 (UMLS CUI 2011AA)
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)
Have a current or previous diagnosis of Gilbert's disease.
Item
Have a current or previous diagnosis of Gilbert's disease.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0017551 (UMLS CUI 2011AA)
27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
E80.4 (ICD-10-CM Version 2010)
Have previous or current diagnosis of Hepatitis B or C
Item
Have previous or current diagnosis of Hepatitis B or C
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
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)
Have a serum creatinine >2 mg/dL or, in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country.
Item
Have a serum creatinine >2 mg/dL or, in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country.
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
CL415147 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Show evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined by the central laboratory at screening. Patients receiving dose-stable thyroid replacement therapy for at least 3 months prior to screening will be allowed to participate in the study.
Item
Show evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined by the central laboratory at screening. Patients receiving dose-stable thyroid replacement therapy for at least 3 months prior to screening will be allowed to participate in the study.
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0205202 (UMLS CUI 2011AA)
33714007 (SNOMED CT 2011_0131)
C0020676 (UMLS CUI 2011AA)
40930008 (SNOMED CT 2011_0131)
10021114 (MedDRA 14.1)
MTHU020783 (LOINC Version 232)
E03.9 (ICD-10-CM Version 2010)
244.9 (ICD-9-CM Version 2011)
E10334 (CTCAE 1105E)
C0020550 (UMLS CUI 2011AA)
34486009 (SNOMED CT 2011_0131)
10020850 (MedDRA 14.1)
MTHU020782 (LOINC Version 232)
E05.9 (ICD-10-CM Version 2010)
242.9 (ICD-9-CM Version 2011)
E10322 (CTCAE 1105E)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0040160 (UMLS CUI 2011AA)
65428006 (SNOMED CT 2011_0131)
MTHU002328 (LOINC Version 232)
Have any other abnormal laboratory value that, in the opinion of the investigator, precludes the patient from participation in the study. Laboratory abnormalities consistent with type 2 diabetes mellitus and all other eligibility criteria are acceptable: for example, abnormalities of blood glucose, hemoglobin A1C (HbA1c), urinary glucose, and urinary protein (with a range of trace to 1+ on dipstick).
Item
Have any other abnormal laboratory value that, in the opinion of the investigator, precludes the patient from participation in the study. Laboratory abnormalities consistent with type 2 diabetes mellitus and all other eligibility criteria are acceptable: for example, abnormalities of blood glucose, hemoglobin A1C (HbA1c), urinary glucose, and urinary protein (with a range of trace to 1+ on dipstick).
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1879533 (UMLS CUI 2011AA)
C1704258 (UMLS CUI 2011AA)
C0005802 (UMLS CUI 2011AA)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0429236 (UMLS CUI 2011AA)
251396006 (SNOMED CT 2011_0131)
C1325413 (UMLS CUI 2011AA)
Have a currently suspected or treated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Item
Have a currently suspected or treated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
boolean
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0687702 (UMLS CUI 2011AA)
10065305 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0154088 (UMLS CUI 2011AA)
92691004 (SNOMED CT 2011_0131)
10036912 (MedDRA 14.1)
D07.5 (ICD-10-CM Version 2010)
233.4 (ICD-9-CM Version 2011)
Have a personal or family history of pancreatic neoplasia.
Item
Have a personal or family history of pancreatic neoplasia.
boolean
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0030297 (UMLS CUI 2011AA)
126859007 (SNOMED CT 2011_0131)
10061902 (MedDRA 14.1)
C1997382 (UMLS CUI 2011AA)
429000004 (SNOMED CT 2011_0131)
Have non-fasting triglycerides >600 mg/dL.
Item
Have non-fasting triglycerides >600 mg/dL.
boolean
C2347359 (UMLS CUI 2011AA)
C0041004 (UMLS CUI 2011AA)
85600001 (SNOMED CT 2011_0131)
MTHU003166 (LOINC Version 232)
Use or have used insulin or GLP-1 agonists (for more than 1 week within the 3-month period prior to screening), or any oral antihyperglycemic medication (OAM) other than metformin within the 3-month period prior to screening.
Item
Use or have used insulin or GLP-1 agonists (for more than 1 week within the 3-month period prior to screening), or any oral antihyperglycemic medication (OAM) other than metformin within the 3-month period prior to screening.
boolean
C0240016 (UMLS CUI 2011AA)
246491008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2916791 (UMLS CUI 2011AA)
C0359086 (UMLS CUI 2011AA)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
Currently use or intend to use prescription or over-the-counter medications, including herbal supplements, to promote weight loss or to regulate blood glucose.
Item
Currently use or intend to use prescription or over-the-counter medications, including herbal supplements, to promote weight loss or to regulate blood glucose.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
CL425124 (UMLS CUI 2011AA)
C1572271 (UMLS CUI 2011AA)
C1874587 (UMLS CUI 2011AA)
Have current chronic (>2 weeks) systemic glucocorticoid therapy (excluding ocular topical, other topical, inhaled preparations)or have received such therapy within 8 weeks prior to screening.
Item
Have current chronic (>2 weeks) systemic glucocorticoid therapy (excluding ocular topical, other topical, inhaled preparations)or have received such therapy within 8 weeks prior to screening.
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
CL428886 (UMLS CUI 2011AA)
10071104 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C1299003 (UMLS CUI 2011AA)
C0360289 (UMLS CUI 2011AA)
350088003 (SNOMED CT 2011_0131)
C0556393 (UMLS CUI 2011AA)
228376009 (SNOMED CT 2011_0131)
Currently use hyperglycemia-causing agents, hypoglycemia-causing agents (other than metformin), class II and III antiarrythmic agents, agents that reduce gastrointestinal motility,central nervous system stimulants (with the exception of caffeinated beverages), fibrates, and niacin >= 1 gm/day.
Item
Currently use hyperglycemia-causing agents, hypoglycemia-causing agents (other than metformin), class II and III antiarrythmic agents, agents that reduce gastrointestinal motility,central nervous system stimulants (with the exception of caffeinated beverages), fibrates, and niacin >= 1 gm/day.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0020456 (UMLS CUI 2011AA)
80394007 (SNOMED CT 2011_0131)
10020635 (MedDRA 14.1)
R73.9 (ICD-10-CM Version 2010)
E12276 (CTCAE 1105E)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C0360701 (UMLS CUI 2011AA)
373278006 (SNOMED CT 2011_0131)
C0360703 (UMLS CUI 2011AA)
372855004 (SNOMED CT 2011_0131)
C0017184 (UMLS CUI 2011AA)
C0002763 (UMLS CUI 2011AA)
349897000 (SNOMED CT 2011_0131)
C1449704 (UMLS CUI 2011AA)
C0027996 (UMLS CUI 2011AA)
273943001 (SNOMED CT 2011_0131)
MTHU002113 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0678438 (UMLS CUI 2011AA)
Have an average weekly alcohol intake that exceeds 2 units per day for males and 1 unit per day for females (1 unit = 12 oz or 360 mL of beer, 5 oz or 150 mL of wine, 1.5 oz or 45 mL of distilled spirits).
Item
Have an average weekly alcohol intake that exceeds 2 units per day for males and 1 unit per day for females (1 unit = 12 oz or 360 mL of beer, 5 oz or 150 mL of wine, 1.5 oz or 45 mL of distilled spirits).
boolean
C1510992 (UMLS CUI 2011AA)
C0332174 (UMLS CUI 2011AA)
14497002 (SNOMED CT 2011_0131)
C0560219 (UMLS CUI 2011AA)
160592001 (SNOMED CT 2011_0131)
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0004922 (UMLS CUI 2011AA)
53410008 (SNOMED CT 2011_0131)
C0043188 (UMLS CUI 2011AA)
35748005 (SNOMED CT 2011_0131)
C0301611 (UMLS CUI 2011AA)
6524003 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
CL407604 (UMLS CUI 2011AA)
C0678793 (UMLS CUI 2011AA)
C0012265 (UMLS CUI 2011AA)
796001 (SNOMED CT 2011_0131)
MTHU001808 (LOINC Version 232)
C0023870 (UMLS CUI 2011AA)
85899009 (SNOMED CT 2011_0131)
MTHU004197 (LOINC Version 232)
C0031507 (UMLS CUI 2011AA)
40556005 (SNOMED CT 2011_0131)
MTHU002993 (LOINC Version 232)
C0039771 (UMLS CUI 2011AA)
372810006 (SNOMED CT 2011_0131)
MTHU004269 (LOINC Version 232)
C0043031 (UMLS CUI 2011AA)
48603004 (SNOMED CT 2011_0131)
MTHU003212 (LOINC Version 232)
Currently use drugs that are known to prolong the QT interval.
Item
Currently use drugs that are known to prolong the QT interval.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
Currently use or intend to use potent inhibitors of CYP3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin.
Item
Currently use or intend to use potent inhibitors of CYP3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0059563 (UMLS CUI 2011AA)
424790003 (SNOMED CT 2011_0131)
C0243077 (UMLS CUI 2011AA)
C1145759 (UMLS CUI 2011AA)
413591007 (SNOMED CT 2011_0131)
MTHU018644 (LOINC Version 232)
C0376637 (UMLS CUI 2011AA)
108695003 (SNOMED CT 2011_0131)
MTHU013846 (LOINC Version 232)
C0525005 (UMLS CUI 2011AA)
108706004 (SNOMED CT 2011_0131)
MTHU013848 (LOINC Version 232)
C0292818 (UMLS CUI 2011AA)
386896009 (SNOMED CT 2011_0131)
MTHU013855 (LOINC Version 232)
C0055856 (UMLS CUI 2011AA)
83999008 (SNOMED CT 2011_0131)
MTHU006897 (LOINC Version 232)
C0064113 (UMLS CUI 2011AA)
387532006 (SNOMED CT 2011_0131)
MTHU002298 (LOINC Version 232)
C0022625 (UMLS CUI 2011AA)
387216007 (SNOMED CT 2011_0131)
MTHU002299 (LOINC Version 232)
C0068485 (UMLS CUI 2011AA)
108435006 (SNOMED CT 2011_0131)
MTHU003461 (LOINC Version 232)
C0286738 (UMLS CUI 2011AA)
108700005 (SNOMED CT 2011_0131)
MTHU008513 (LOINC Version 232)
C1452484 (UMLS CUI 2011AA)
395260006 (SNOMED CT 2011_0131)
MTHU016681 (LOINC Version 232)
Have previously completed or withdrawn from this study or any other study investigating LY2409021.
Item
Have previously completed or withdrawn from this study or any other study investigating LY2409021.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C2349954 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Have known allergies to LY2409021 or related compounds.
Item
Have known allergies to LY2409021 or related compounds.
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0205198 (UMLS CUI 2011AA)
62105006 (SNOMED CT 2011_0131)
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, 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 investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
boolean
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C1516879 (UMLS CUI 2011AA)
C0079816 (UMLS CUI 2011AA)
C0679426 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Have any other condition such as alcohol abuse, drug abuse, or psychiatric disorder that may affect the ability to participate in the trial.
Item
Have any other condition such as alcohol abuse, drug abuse, or psychiatric disorder that may affect the ability to participate in the trial.
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
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)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)