Diabetes Mellitus, Non-Insulin-Dependent
Item
1. diagnosis of type 2 diabetes mellitus (t2dm)
boolean
C0011860 (UMLS CUI [1])
Gender | African American | Diet therapy | Exercise | Pharmaceutical Preparations Absent | Pretreatment Metformin Dose Stable
Item
2. male and female black/african american patients on diet and exercise regimen who are drug-naïve or pre-treated with stable dose of metformin.
boolean
C0079399 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C3539076 (UMLS CUI [6,1])
C0025598 (UMLS CUI [6,2])
C0178602 (UMLS CUI [6,3])
C0205360 (UMLS CUI [6,4])
Hemoglobin A1c measurement
Item
3. hba1c of greater than and equal to 7.5% (58 mmol/mol) and less than and equal to 11.0% (97 mmol/mol) at screening
boolean
C0474680 (UMLS CUI [1])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
4. mean seated systolic blood (sbp) 140-180 mmhg and diastolic blood pressure (dbp) 90-110 mmhg at screening
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Ambulatory Blood Pressure Monitoring Completion | Systolic Pressure mean
Item
5. successful completion of baseline ambulatory blood pressure measurement (abpm) with a mean sbp 135-175 mmhg prior to randomization.
boolean
C0242876 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Antihypertensive Agents Quantity Dose Stable
Item
6. treatment with stable doses of less than and equal to 3 antihypertensive medication greater than and equal to 4 weeks prior to randomization.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Age
Item
7. age greater than and equal to18 years at screening
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
8. signed and dated written informed consent
boolean
C0021430 (UMLS CUI [1])
Hyperglycemia Uncontrolled | Glucose level | Status post Fasting Overnight
Item
1. uncontrolled hyperglycaemia with a glucose level >270 mg/dl (>15.0 mmol/l) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0428548 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0015663 (UMLS CUI [3,2])
C0439583 (UMLS CUI [3,3])
Antidiabetics | Exception Metformin
Item
2. any other antidiabetic medication other than metformin.
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Hypertension treatment | Minoxidil
Item
3. hypertension treatment with minoxidil.
boolean
C0578998 (UMLS CUI [1])
C0026196 (UMLS CUI [2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
4. mean seated sbp >=181 mmhg and/or mean seated dbp>=111 mmhg during placebo run-in visit and confirmed by a second measurement.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Diabetes, Autoimmune | Diabetes Mellitus, Insulin-Dependent | Monogenic diabetes | Neonatal diabetes mellitus | Maturity onset diabetes mellitus in young | Insulin-Dependent Diabetes Mellitus Adult | Latent Autoimmune Diabetes in Adults
Item
5. diagnosis of autoimmune diabetes/type i diabetes mellitus, monogenic (neonatal or mody) diabetes or type i diabetes in adults/ latent autoimmune diabetes of adults (lada) per investigator or patient medical history at the time of screening.
boolean
C0205734 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C3888631 (UMLS CUI [3])
C0158981 (UMLS CUI [4])
C0342276 (UMLS CUI [5])
C0011854 (UMLS CUI [6,1])
C0001675 (UMLS CUI [6,2])
C1739108 (UMLS CUI [7])
Secondary hypertension | Secondary hypertension Suspected | Renal Artery Stenosis | Pheochromocytoma
Item
6. known or suspected secondary hypertension (e.g. renal artery stenosis, phaeochromocytoma).
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0035067 (UMLS CUI [3])
C0031511 (UMLS CUI [4])
Hypertensive Retinopathy Grade | Hypertensive Encephalopathy
Item
7. history or evidence of hypertensive retinopathy (keith-wagener grade iii or iv) and/or hypertensive encephalopathy.
boolean
C0152132 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0151620 (UMLS CUI [2])
Renal Insufficiency | Estimated Glomerular Filtration Rate | Renal Insufficiency Moderate | Creatinine-based formula (CKD-EPI)
Item
8. impaired renal function, defined as estimated glomerular filtration rate (egfr)< 45 ml/min/1.73m2 (moderate renal impairment,chronic kidney disease epidemiology collaboration (ckd-epi) formula) as determined during screening and/or run-in phase.
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C1565489 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C2964649 (UMLS CUI [4])
Diabetic Autonomic Neuropathy | Signs and Symptoms Diabetic Autonomic Neuropathy
Item
9. medical history and signs and symptoms of diabetic autonomic neuropathy.
boolean
C0271686 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0271686 (UMLS CUI [2,2])
Systolic Pressure Difference Arm
Item
10. systolic blood pressure difference of >10 mmhg between the arms at screening.
boolean
C0871470 (UMLS CUI [1,1])
C1705242 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
Premenopausal state
Item
11. pre-menopausal women who:
boolean
C0232969 (UMLS CUI [1])
Breast Feeding | Pregnancy
Item
are nursing or pregnant or
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Periodic Unwilling
Item
are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0332182 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])