Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Hypoglycemic Agents Oral | Insulin | Metformin U/day | Sulfonylurea Daily Dose | Thiazolidinediones | pioglitazone U/day | rosiglitazone U/day
Item
have been receiving oral antihyperglycemic medications (oam) without insulin including at least two of the following at maximally tolerated doses, and meet the minimum dosing criteria shown: metformin 1500 mg/day, sulfonylurea 1/2 the maximum daily dose, according to package insert, thiazolidinedione (tzd) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. the oams also must be used in accordance with the product label
boolean
C0020616 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4,1])
C2348070 (UMLS CUI [4,2])
C1257987 (UMLS CUI [5])
C0071097 (UMLS CUI [6,1])
C0456683 (UMLS CUI [6,2])
C0289313 (UMLS CUI [7,1])
C0456683 (UMLS CUI [7,2])
Glycosylated hemoglobin A Percentage
Item
have a hemoglobin a1c greater than or equal to 7.5% and less than or equal to 12.0%.
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Thiazolidinediones High dose | Insulin
Item
are taking a tzd dose greater than what is indicated in combination with insulin according to the tzd label.
boolean
C1257987 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])
Hypoglycemic Agents
Item
are taking any other glucose-lowering agents not mentioned in inclusion criterion.
boolean
C0020616 (UMLS CUI [1])
Acarbose | miglitol | Pramlintide | exenatide | repaglinide | nateglinide
Item
have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
boolean
C0050393 (UMLS CUI [1])
C0066535 (UMLS CUI [2])
C0537551 (UMLS CUI [3])
C0167117 (UMLS CUI [4])
C0246689 (UMLS CUI [5])
C0903898 (UMLS CUI [6])
Body mass index
Item
have a body mass index greater than 40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Hypoglycemia Severe Episode Quantity
Item
have had more than one episode of severe hypoglycemia in the last24 weeks
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
are pregnant, intend to be pregnant during the course of the study or are breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Heart Disease | Kidney Disease | Hematological Disease | Malignant Neoplasm | Liver disease
Item
have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
boolean
C0018799 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C0023895 (UMLS CUI [5])