Age
Item
male or female, age 18-75
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Metformin Maximum Tolerated Dose | Sulfonylureas Maximum Tolerated Dose | Poor glycemic control | Hemoglobin A1c measurement
Item
at least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (hemoglobin a1c (hba1c) >7.0%)
boolean
C0025598 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C0038766 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0342299 (UMLS CUI [3])
C0474680 (UMLS CUI [4])
Protocol Compliance
Item
able to comply with all scheduled visits and requirements of the protocol
boolean
C0525058 (UMLS CUI [1])
Medical contraindication Metformin | Medical contraindication Sulfonylurea
Item
any contraindications to the use of metformin or a sulfonylurea agent
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
Hyperglycemia Extreme | Symptoms Polyuria | Symptoms Polydipsia
Item
extreme hyperglycemia or symptoms of polyuria or polydipsia
boolean
C0020456 (UMLS CUI [1,1])
C0205403 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0032617 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0085602 (UMLS CUI [3,2])
Insulin | Insulin chronic | Exception Therapy Gestational Diabetes
Item
current or previous chronic use of insulin (other than for treatment of gestational diabetes)
boolean
C0021641 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0085207 (UMLS CUI [3,3])
Diabetes Mellitus, Insulin-Dependent | Suspicion Clinical Insulin-Dependent Diabetes Mellitus
Item
history of confirmed (or clinical suspicion of) type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0011854 (UMLS CUI [2,3])
Episode of HYPOGLYCEMIA SYMPTOMATIC times/day
Item
episodes of symptomatic hypoglycemia averaging greater than once per day
boolean
C0332189 (UMLS CUI [1,1])
C0745152 (UMLS CUI [1,2])
C0439511 (UMLS CUI [1,3])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate (egfr) < 60 ml/min
boolean
C3811844 (UMLS CUI [1])
Anemia, Hemolytic | Hemoglobin variant result | Hemoglobin A1c measurement unreliable
Item
subjects with active hemolytic anemias or hemoglobin variants that render the measurement of hba1c unreliable
boolean
C0002878 (UMLS CUI [1])
C1287255 (UMLS CUI [2])
C0474680 (UMLS CUI [3,1])
C0749770 (UMLS CUI [3,2])
Liver disease | Cardiovascular Disease | Digoxin | Systemic disease Major | Use of Sitagliptin At risk | Interpretation Research data Difficult
Item
history of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult.
boolean
C0023895 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0012265 (UMLS CUI [3])
C0442893 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C1524063 (UMLS CUI [5,1])
C1565750 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0459471 (UMLS CUI [6,1])
C0681873 (UMLS CUI [6,2])
C0332218 (UMLS CUI [6,3])
Childbearing Potential Sexually active Contraceptive methods Absent
Item
female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
current pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmacotherapy Interferes with Glucose metabolism
Item
subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study.
boolean
C0013216 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Informed Consent Unable | Informed Consent Unwilling | Protocol Compliance Unable | Protocol Compliance Unwilling | Barriers to treatment | Implementation Study Protocol Difficult
Item
subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0679881 (UMLS CUI [5])
C1708476 (UMLS CUI [6,1])
C2348563 (UMLS CUI [6,2])
C0332218 (UMLS CUI [6,3])