Age
Item
1. is 18 to 75 years of age, inclusive;
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
2. has a clinical diagnosis of type 2 diabetes mellitus;
boolean
C0011860 (UMLS CUI [1])
Anti-GAD antibody negative
Item
3. is anti-glutamic acid decarboxylase (gad) antibody negative;
boolean
C1167898 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. has an a1c ≥ 7.0% and ≤ 10.5%;
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
5. has a body mass index (bmi) ≥ 25 kg/m2 and ≤ 40 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Antidiabetics Oral Quantity | Insulin Basal | Bolus Insulin Basal | exenatide | Byetta | Pramlintide | Symlin
Item
6. is treated with either ≥ 2 oral antidiabetic agents (oa) or basal insulin ± oa(s) or basal-bolus insulin ± oa(s) for at least 3 months (subjects may also be treated with exenatide [byetta] or pramlintide [symlin].
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2,1])
C0205112 (UMLS CUI [2,2])
C1705509 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C0205112 (UMLS CUI [3,3])
C0167117 (UMLS CUI [4])
C1636686 (UMLS CUI [5])
C0537551 (UMLS CUI [6])
C1174780 (UMLS CUI [7])
Metformin | Creatinine measurement, serum | Gender
Item
7. if on concomitant metformin, has serum creatinine < 1.5 mg/dl (male) or <1.4 mg/dl (female);
boolean
C0025598 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Gender Urine pregnancy test negative
Item
8. if female, has a negative urine pregnancy test
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Recurrent severe hypoglycemia Episodes Quantity | Requirement Assistance
Item
1. has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months;
boolean
C0342316 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C1269765 (UMLS CUI [2,2])
Cardiovascular Disease | Myocardial Infarction | Cerebrovascular accident | Revascularization Arterial | Angina Pectoris With Resting ECG Changes Ischemic | Exercise test Changes | Cardiac imaging procedure Positive
Item
2. has clinical cardiovascular disease (cvd) as evidenced by prior myocardial infarction, stroke, arterial revascularization and/or angina with ischemic changes on ecg at rest, changes on graded exercise test, or positive cardiac imaging test results;
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0581603 (UMLS CUI [4,1])
C0221464 (UMLS CUI [4,2])
C0002962 (UMLS CUI [5,1])
C0332287 (UMLS CUI [5,2])
C3897699 (UMLS CUI [5,3])
C0475224 (UMLS CUI [5,4])
C0015260 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
C1096014 (UMLS CUI [7,1])
C1514241 (UMLS CUI [7,2])
12 lead ECG Abnormality
Item
3. has abnormalities on the screening (visit 1) 12-lead ecg that are deemed by the investigator to be clinically significant;
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Systemic steroids Oral | Systemic steroids Intravenous | Systemic steroids Intramuscular | Inhaled steroids | Steroids Intrapulmonary | Steroids Intranasal | Topical steroids
Item
4. is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route or potent inhaled,intrapulmonary, intranasal, or topical steroids that are known to have a high rate of systemic absorption;
boolean
C2825233 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C2825233 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4])
C0038317 (UMLS CUI [5,1])
C1522224 (UMLS CUI [5,2])
C0038317 (UMLS CUI [6,1])
C0001560 (UMLS CUI [6,2])
C2064827 (UMLS CUI [7])
Substance Use Disorders | Compliance behavior Lacking
Item
5. currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be non-compliant;
boolean
C0038586 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Medical condition Affecting Completion of clinical trial | Laboratory finding Affecting Completion of clinical trial | Medical History Affecting Completion of clinical trial | Medical condition Affecting Personal Well-Being | Laboratory finding Affecting Personal Well-Being | Medical History Affecting Personal Well-Being
Item
6. has any significant medical condition, laboratory findings, or medical history that in the investigator's opinion may affect successful completion of the study and/or personal well-being;
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1821407 (UMLS CUI [4,3])
C0587081 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1821407 (UMLS CUI [5,3])
C0262926 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C1821407 (UMLS CUI [6,3])