age 18 Years to 70 Years
Item
age 18 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
Item
Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
boolean
C0011900 (UMLS CUI 1)
C0011860 (UMLS CUI 1*1)
May be treated with:
Item
May be treated with:
boolean
CL415205 (UMLS CUI 2011AA)
C0332293 (UMLS CUI 2011AA)
28995006 (SNOMED CT 2011_0131)
1. Diet and exercise alone or
Item
1. Diet and exercise alone or
boolean
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
2. Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
Item
2. Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
boolean
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C1947911 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
3. Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
Item
3. Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
boolean
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C1947911 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0038766 (UMLS CUI 2011AA)
C1579432 (UMLS CUI 2011AA)
C0246689 (UMLS CUI 2011AA)
386964000 (SNOMED CT 2011_0131)
MTHU017515 (LOINC Version 232)
C1323198 (UMLS CUI 2011AA)
387070004 (SNOMED CT 2011_0131)
MTHU026435 (LOINC Version 232)
4. Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years
Item
4. Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years
boolean
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C1947911 (UMLS CUI 2011AA)
C0038766 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C1579432 (UMLS CUI 2011AA)
Must have an Hemoglobin A1c value between 7% and 10%
Item
Must have an Hemoglobin A1c value between 7% and 10%
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
Must have a body mass index (BMI) between 20 and 40 kg/m2
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))
Item
Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))
boolean
C0005910 (UMLS CUI 2011AA)
If female, you must not be able to get pregnant
Item
If female, you must not be able to get pregnant
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction
Item
Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction
boolean
C0026605 (UMLS CUI 2011AA)
363882003 (SNOMED CT 2011_0131)
C2698977 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
C0302828 (UMLS CUI 2011AA)
Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
Item
Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
boolean
C0240016 (UMLS CUI 2011AA)
246491008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
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)
C0038766 (UMLS CUI 2011AA)
C1579432 (UMLS CUI 2011AA)
Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery
Item
Have a gastrointestinal disease that significantly impacts 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 more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
Item
Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
boolean
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)
C0853088 (UMLS CUI 2011AA)
10020997 (MedDRA 14.1)
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)
C0858269 (UMLS CUI 2011AA)
10024858 (MedDRA 14.1)
Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
Item
Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
boolean
C1512806 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
Have cardiac disease with functional status that is New York Heart Association [NYHA] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
Item
Have cardiac disease with functional status that is New York Heart Association [NYHA] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
boolean
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
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)
C1275835 (UMLS CUI 2011AA)
399211009 (SNOMED CT 2011_0131)
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)
C0205434 (UMLS CUI 2011AA)
5650002 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization
Item
Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020540 (UMLS CUI 2011AA)
70272006 (SNOMED CT 2011_0131)
10025600 (MedDRA 14.1)
C0035067 (UMLS CUI 2011AA)
302233006 (SNOMED CT 2011_0131)
10038378 (MedDRA 14.1)
C0428895 (UMLS CUI 2011AA)
251080003 (SNOMED CT 2011_0131)
10023533 (MedDRA 14.1)
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)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
Have a QTcB (Bazett's-corrected QT interval) interval > 450 msec for men or > 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
Item
Have a QTcB (Bazett's-corrected QT interval) interval > 450 msec for men or > 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
boolean
C1882512 (UMLS CUI 2011AA)
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0042514 (UMLS CUI 2011AA)
25569003 (SNOMED CT 2011_0131)
10047302 (MedDRA 14.1)
I47.2 (ICD-10-CM Version 2010)
E10239 (CTCAE 1105E)
C0039070 (UMLS CUI 2011AA)
272030005 (SNOMED CT 2011_0131)
10042772 (MedDRA 14.1)
MTHU020851 (LOINC Version 232)
R55 (ICD-10-CM Version 2010)
780.2 (ICD-9-CM Version 2011)
E12832 (CTCAE 1105E)
C1705492 (UMLS CUI 2011AA)
C0681841 (UMLS CUI 2011AA)
MTHU013812 (LOINC Version 232)
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
Item
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
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)
C0267797 (UMLS CUI 2011AA)
37871000 (SNOMED CT 2011_0131)
10019727 (MedDRA 14.1)
B17.9 (ICD-10-CM Version 2010)
C0019189 (UMLS CUI 2011AA)
76783007 (SNOMED CT 2011_0131)
10008909 (MedDRA 14.1)
K73.9 (ICD-10-CM Version 2010)
571.40 (ICD-9-CM Version 2011)
C0877359 (UMLS CUI 2011AA)
10048557 (MedDRA 14.1)
Are currently receiving renal dialysis, have a serum creatinine > 2.0 mg/dL (177 micromol/L) or a calculated creatinine clearance of < 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
Item
Are currently receiving renal dialysis, have a serum creatinine > 2.0 mg/dL (177 micromol/L) or a calculated creatinine clearance of < 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
boolean
C1514756 (UMLS CUI 2011AA)
C0917873 (UMLS CUI 2011AA)
265764009 (SNOMED CT 2011_0131)
10049051 (MedDRA 14.1)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1441506 (UMLS CUI 2011AA)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
Have fasting state hypertriglyceridemia (defined as > 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
Item
Have fasting state hypertriglyceridemia (defined as > 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
boolean
C1976106 (UMLS CUI 2011AA)
MTHU026462 (LOINC Version 232)
C0020557 (UMLS CUI 2011AA)
302870006 (SNOMED CT 2011_0131)
10020869 (MedDRA 14.1)
E12299 (CTCAE 1105E)
C1409616 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C1512806 (UMLS CUI 2011AA)
C0003367 (UMLS CUI 2011AA)
57952007 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
Are receiving chronic (for > 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
Item
Are receiving chronic (for > 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
boolean
C1514756 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0744425 (UMLS CUI 2011AA)
10071104 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0360289 (UMLS CUI 2011AA)
350088003 (SNOMED CT 2011_0131)
C0556393 (UMLS CUI 2011AA)
228376009 (SNOMED CT 2011_0131)
Have an active or untreated malignancy or have been 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 < 5 years
Item
Have an active or untreated malignancy or have been 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 < 5 years
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
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 history of seizure disorder
Item
Have a history of seizure disorder
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0014544 (UMLS CUI 2011AA)
84757009, 313307000 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
Item
Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1283828 (UMLS CUI 2011AA)
363703001 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2962753 (UMLS CUI 2011AA)
Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index
Item
Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index
boolean
C1512806 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0332324 (UMLS CUI 2011AA)
83185005 (SNOMED CT 2011_0131)
C0178623 (UMLS CUI 2011AA)
C1142644 (UMLS CUI 2011AA)
422741004 (SNOMED CT 2011_0131)
C1706062 (UMLS CUI 2011AA)
CL407604 (UMLS CUI 2011AA)
C0678793 (UMLS CUI 2011AA)