Diabetes Mellitus, Non-Insulin-Dependent | Sulfonylureas Dose Stable | Metformin Dose Stable | Combined Modality Therapy
Item
diagnosis of type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
boolean
C0011860 (UMLS CUI [1])
C0038766 (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])
C0009429 (UMLS CUI [4])
Age | Female infertility | Gender Barrier Contraception Double
Item
males and females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0004764 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
Hemoglobin A1c measurement
Item
hba1c must be ≥7.5% and ≤10% at screening
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose must be <240 mg/dl at screening
boolean
C0583513 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
history of diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Cardiac Status New York Heart Association Classification | Hospitalization Due to Congestive heart failure
Item
nyha class iii or iv cardiac status or hospitalization for congestive heart failure within 6 weeks prior to visit 1
boolean
C1999091 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0018802 (UMLS CUI [2,3])
Antidiabetics Investigational | Antidiabetics Approved | Exception Peroxisome Proliferator-Activated Receptors | Exception Metformin | Exception Sulfonylureas
Item
treatment with any non-peroxisome proliferator-activated receptor (non-ppar) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening
boolean
C0935929 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C0205540 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0166418 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038766 (UMLS CUI [5,2])
rosiglitazone | pioglitazone | Antidiabetics Investigational PPAR
Item
treatment with rosiglitazone, pioglitazone, or any ppar investigational antidiabetic agent within 6 month prior to screening
boolean
C0289313 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0166418 (UMLS CUI [3,3])
Body mass index
Item
body mass index >45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Serum fasting triglyceride measurement
Item
fasting triglycerides >500 mg/dl
boolean
C0582824 (UMLS CUI [1])
Uncontrolled hypertension | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
uncontrolled hypertension (sitting systolic blood pressure >160 mmhg and/or sitting diastolic blood pressure >100 mmhg
boolean
C1868885 (UMLS CUI [1])
C1319893 (UMLS CUI [2])
C1319894 (UMLS CUI [3])
Complications of Diabetes Mellitus Complicating Study Subject Participation Status | Patient need for Medication New
Item
presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)
boolean
C0342257 (UMLS CUI [1,1])
C1522701 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205314 (UMLS CUI [2,3])