Age
Item
males or females 20-75 years of age inclusive.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Insulin regime
Item
on insulin therapy
boolean
C0557978 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≥7.5% and ≤ 9%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi ≥ 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Statins Dose Stable | Angiotensin-Converting Enzyme Inhibitors Dose Stable | Metformin Dose Stable | Thiazolidinediones Dose Stable | Antioxidants Dose Stable | Pharmaceutical Preparations Dose unchanged
Item
subjects on statins, ace inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.
boolean
C0360714 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1257987 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0003402 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0442739 (UMLS CUI [6,3])
Event Coronary | Procedures on Coronary Arteries | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Operative Surgical Procedures | Coronary angioplasty
Item
coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
boolean
C0441471 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0869781 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C0543467 (UMLS CUI [6])
C0190211 (UMLS CUI [7])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Liver diseases | Liver function tests abnormal
Item
hepatic disease (abnormal lft's)
boolean
C0023895 (UMLS CUI [1])
C0151766 (UMLS CUI [2])
Dipeptidyl-Peptidase IV Inhibitors
Item
use of dpp4 inhibitors.
boolean
C1827106 (UMLS CUI [1])
Renal Insufficiency | Creatinine measurement, serum
Item
renal impairment (serum creatinine > 1.5)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in any other concurrent clinical trial
boolean
C2348568 (UMLS CUI [1])
Life threatening illness | Exception Heart Disease
Item
any other life-threatening, non-cardiac disease
boolean
C3846017 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
Uncontrolled hypertension | Blood pressure determination
Item
uncontrolled hypertension (bp > 160/100 mm of hg)
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Congestive heart failure
Item
congestive heart failure.
boolean
C0018802 (UMLS CUI [1])
Investigational New Drugs | Therapies, Investigational
Item
use of an investigational agent or therapeutic regimen within 30 days of study
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])