Age | Diabetes Mellitus, Non-Insulin-Dependent | C-peptide level
Item
1. male or female patient, at least 18 years of age with known type 2 diabetes, diagnosis of type 2 diabetes should have been made at > 30 years of age (if diabetes developed at a younger age, c-peptide level may be obtained to confirm diagnosis)
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0202100 (UMLS CUI [3])
Estimated Glomerular Filtration Rate Quantity Average
Item
2. the average of two egfr values collected during screening must be within 20 - 45 ml/min/1.73m2, inclusive
boolean
C3811844 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable
Item
3. patient must be receiving an angiotensin converting enzyme (ace) inhibitor and/or an angiotensin ii receptor blocker (arb) for at least 3 months prior to screening, where the dose of the ace inhibitor or the arb is considered appropriate for that patient, and has been stable and maintained on that dose for at least 8 weeks prior to the randomization visit
boolean
C0003015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Contraceptive methods | Exception Infertility
Item
4. for male and female subjects, agreement to use effective contraception during the entire study period and for at least 2 months after the last dose of study drug, unless documentation of infertility exists
boolean
C0700589 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021359 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
5. women of child-bearing potential, she must have a negative serum pregnancy test at screening and a negative urine pregnancy test confirmed within 72 hours prior to the first dose of study medication
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Protocol Compliance
Item
6. patient is willing and able to cooperate with all aspects of the protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
7. patient is willing and able to give written informed consent for study participation.
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis
Item
1. type 1 (insulin-dependent; juvenile onset) diabetes, or any history of diabetic ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Kidney Disease | Exception Diabetes Mellitus | Kidney Transplantation
Item
2. patients with known non-diabetic renal disease or patients with a history of a renal transplant
boolean
C0022658 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0022671 (UMLS CUI [3])
Glucohemoglobin measurement
Item
3. patients with a hemoglobin a1c >10% collected at the screening a visit
boolean
C0202054 (UMLS CUI [1])
Cardiovascular Diseases | Angina, Unstable | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Transient Ischemic Attack | Cerebrovascular accident | Heart valve disease Obstructive | Hypertrophic Cardiomyopathy | Congestive heart failure New York Heart Association Classification
Item
4. cardiovascular disease as follows: unstable angina pectoris within 3 months prior to study randomization; myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months prior to study randomization; transient ischemic attack within 3 months of study randomization; cerebrovascular accident within 3 months of study randomization; obstructive valvular heart disease or hypertrophic cardiomyopathy; diagnosis of class iii or iv congestive heart failure at any time
boolean
C0007222 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C2936173 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0018824 (UMLS CUI [8,1])
C0549186 (UMLS CUI [8,2])
C0007194 (UMLS CUI [9])
C0018802 (UMLS CUI [10,1])
C1275491 (UMLS CUI [10,2])
Systolic Pressure | Diastolic blood pressure
Item
5. systolic blood pressure (bp) >160 mmhg and diastolic blood pressure > 90 determined by the average of three seated readings taken at least 5 minutes apart, at each of two time-points at least 5 days apart during the screening period
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
QTc interval ECG Quantity
Item
6. qtc fredericia interval > 450 milliseconds determined by the average of values reported by a central reader from three ecgs taken at the screening a visit. each of the three ecgs will be obtained using only equipment provided by the sponsor, and the ecgs shall be obtained at least ten minutes apart.
boolean
C0489625 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Unsuccessful
Item
7. second or third degree atrioventricular block not successfully treated with a pacemaker
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0030163 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
Therapeutic immunosuppression chronic Patient need for | Adrenal Cortex Hormones Patient need for | Exception Intra-Articular Injections | Exception Inhaled steroids | Exception Steroids Nasal
Item
8. need for chronic (>2 weeks) immunosuppressive therapy, or need for corticosteroids (excluding intraarticular injections,inhaled or nasal steroids) within 3 months of study randomization
boolean
C0021079 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0021488 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2065041 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038317 (UMLS CUI [5,2])
C1522019 (UMLS CUI [5,3])
Liver Dysfunction | Dysfunction biliary | Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised
Item
9. evidence of hepatic or biliary dysfunction including total bilirubin >1.0 mg/dl (>17 micromol/l), aspartate aminotransferase (ast) or alanine aminotransferase (alt) > upper limit of normal (uln), or alkaline phosphatase >2.0 uln on any screening lab
boolean
C0086565 (UMLS CUI [1])
C3887504 (UMLS CUI [2,1])
C0521378 (UMLS CUI [2,2])
C1278039 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
C0151849 (UMLS CUI [6])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
10. if female, patient is pregnant, nursing or planning a pregnancy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Medical condition Study Subject Participation Status At risk Patient | Medical condition Influence Research results
Item
11. patient has any concurrent clinical conditions that in the judgment of the investigator could either potentially pose a health risk to the patient while involved in the study or could potentially influence the study outcome
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Hypersensitivity Investigational New Drug Component
Item
12. patient has known hypersensitivity to any component of the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Diagnostic procedure Requirement Contrast Media | Interventional procedure Requirement Contrast Media
Item
13. patient has undergone a diagnostic or interventional procedure requiring a contrast agent within 30 days prior to randomization
boolean
C0430022 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0009924 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0009924 (UMLS CUI [2,3])
Pharmaceutical Preparations Change | Pharmaceutical Preparations Dose Adjustment | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
14. change or dose adjustment in any of the following medications within 8 weeks prior to randomization into the study or anticipated change in dose within 30 days following randomization into the study: ace inhibitors, angiotensin ii receptor blockers.
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2826232 (UMLS CUI [2,2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
Pharmaceutical Preparations Change | Pharmaceutical Preparations Dose Adjustment | Antihypertensive Agents | Antidiabetics
Item
15. change or dose adjustment of any other anti-hypertensive, and other anti-diabetic medications within 8 weeks prior to randomization or anticipated change in dose within 30 days following randomization into the study
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2826232 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3])
C0935929 (UMLS CUI [4])
Substance Use Disorders
Item
16. patient has a current history of drug or alcohol abuse as per the investigator's assessment
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status | Bardoxolone methyl
Item
17. patient has participated in another investigational study within 30 days prior to randomization into the study or would concomitantly participate in such a study, or has previously participated in a trial involving bardoxolone methyl.
boolean
C2348568 (UMLS CUI [1])
C1100924 (UMLS CUI [2])
Lacking Able to communicate | Compliance behavior Lacking | Language problems | Development; delayed, mental | Cerebral function Impaired
Item
18. patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development or impaired cerebral function
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1405458 (UMLS CUI [3])
C1410968 (UMLS CUI [4])
C0234386 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
Subject Diary Use of Unable | Subject Diary Use of Unwilling
Item
19. patient is unable or unwilling to utilize the daily phone diary to track the date and time they take their study medication
boolean
C3890583 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3890583 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Pharmaceutical Preparations Hepatotoxicity | Acetylcysteine | Mucomyst | Acetadote | Fluimucil | Parvolex | Niacin | Nicotinic Acids | Dantrium | Dantrolene | isoniazid | Normodyne | Labetalol | Cylert | Pemoline | Felbatol | felbamate | Zyflo | zileuton | Tasmar | tolcapone | Trovan | trovafloxacin
Item
20. patients on any of the following known hepatotoxic agents: antioxidant n-acetly-cysteine (mucomyst, acetadote, fluimucil, parvolex), niacin (nicotinic acid), dantrium (dantrolene), naizide (isoniazid), normodyne (labetalol), cylert (pemoline), felbatol (felbamate), zyflo (zileuton), tasmar (tolcapone), or trovan (trovafloxacin). patients must have been off the aforementioned medications for a minimum of two weeks prior to randomization
boolean
C0013227 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
C0001047 (UMLS CUI [2])
C0699252 (UMLS CUI [3])
C1330030 (UMLS CUI [4])
C0699251 (UMLS CUI [5])
C0135546 (UMLS CUI [6])
C0027996 (UMLS CUI [7])
C0028049 (UMLS CUI [8])
C0010975 (UMLS CUI [9])
C0010976 (UMLS CUI [10])
C0022209 (UMLS CUI [11])
C0600256 (UMLS CUI [12])
C0022860 (UMLS CUI [13])
C0719594 (UMLS CUI [14])
C0030800 (UMLS CUI [15])
C0728742 (UMLS CUI [16])
C0060135 (UMLS CUI [17])
C0724508 (UMLS CUI [18])
C0081408 (UMLS CUI [19])
C0595276 (UMLS CUI [20])
C0246330 (UMLS CUI [21])
C0723938 (UMLS CUI [22])
C0379881 (UMLS CUI [23])
Fenofibrate Discontinue Unable | Fenofibrate Discontinue Unwilling | Antara | Fenoglide | Lipofen | Lofibra | Tricor | Triglide | Fenofibrate To be stopped
Item
21. patients who are unable or unwilling to discontinue fenofibrate (antara, fenoglide, lipofen, lofibra, tricor, triglide) during the first three months of study treatment. patients must have been off fenofibrate for a minimum of two weeks prior to randomization
boolean
C0033228 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0033228 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1617247 (UMLS CUI [3])
C2342283 (UMLS CUI [4])
C1701349 (UMLS CUI [5])
C1170377 (UMLS CUI [6])
C0723893 (UMLS CUI [7])
C1620426 (UMLS CUI [8])
C0033228 (UMLS CUI [9,1])
C1272691 (UMLS CUI [9,2])
Non-Steroidal Anti-Inflammatory Agents Regular Patient need for
Item
22. patients who require more than occasional (once or twice weekly) use of non-steroidal anti-inflammatory agents (nsaids)
boolean
C0003211 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
Neoplastic disease | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
23. patients with a history of neoplastic disease (except basal or squamous cell carcinoma of the skin) within 5 years prior to the randomization visit;
boolean
C1882062 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Dialysis | Renal function Unstable
Item
24. patients who have had prior dialysis within three months of randomization and/or have not maintained a stable level of kidney function within three months of randomization per investigator assessment
boolean
C0011946 (UMLS CUI [1])
C0232804 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])