Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents Quantity | Thiazolidinediones Excluded | Sulfonylurea Compounds | Glyburide | Glipizide | glimepiride | Meglitinide | Prandin | Starlix | Metformin | Glucophage | alpha-Glucosidase Inhibitors | Acarbose | miglitol | Byetta
Item
type 2 diabetes previously controlled with up to one or two non-tzd hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., prandin®, starlix®), metformin (e.g., glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or byetta®
boolean
C0011860 (UMLS CUI [1])
C0020616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1257987 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4])
C0017628 (UMLS CUI [5])
C0017642 (UMLS CUI [6])
C0061323 (UMLS CUI [7])
C0065880 (UMLS CUI [8])
C0722725 (UMLS CUI [9])
C1323198 (UMLS CUI [10])
C0025598 (UMLS CUI [11])
C0591573 (UMLS CUI [12])
C1299007 (UMLS CUI [13])
C0050393 (UMLS CUI [14])
C0066535 (UMLS CUI [15])
C1636686 (UMLS CUI [16])
Female Sterilization | Postmenopausal state
Item
all female patients must be either surgically sterile or post-menopausal.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Gender Male Condoms | Partner Female Childbearing Potential | Childbearing Potential Contraceptive methods
Item
male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception.
boolean
C0079399 (UMLS CUI [1,1])
C0009653 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0086287 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Body mass index
Item
bmi 24-44 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
patients must have a fpg ≤ 200 mg/dl at screening.
boolean
C0583513 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
patients must have hemoglobin a1c ≥ 6.5%, ≤ 10.0% at screening.
boolean
C0019018 (UMLS CUI [1])
ECG normal | Chest X-ray normal
Item
electrocardiogram (ecg) and chest x-ray must be normal, or considered not clinically significant, for participation in this study.
boolean
C0522054 (UMLS CUI [1])
C0239026 (UMLS CUI [2])
Blood Pressure | Hypertensive disease Controlled by Pharmaceutical Preparations
Item
patients must have a blood pressure ≤ 160/90 mm/hg including hypertensive patients controlled with medication.
boolean
C0005823 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C0332298 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy
Item
history of type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy.
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0030305 (UMLS CUI [2,3])
C0011849 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0030279 (UMLS CUI [3,3])
Thiazolidinediones | Actos | Avandia
Item
history of tzd use (actos or avandia) within 6 months of screening visit.
boolean
C1257987 (UMLS CUI [1])
C0875954 (UMLS CUI [2])
C0875967 (UMLS CUI [3])
Thiazolidinediones Discontinued Due to Lack of Efficacy
Item
history of tzd discontinuation due to lack of efficacy.
boolean
C1257987 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0235828 (UMLS CUI [1,4])
Congestive heart failure Disease length
Item
history of congestive heart failure within last 5 years.
boolean
C0018802 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Lung diseases | Myocardial Infarction | Cerebrovascular accident | Nephrotic Syndrome
Item
history of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year.
boolean
C0024115 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0027726 (UMLS CUI [4])
Malignant Neoplasms | Basal cell carcinoma Resected Excluded
Item
malignancy within the last 5 years (except resected basal cell carcinoma).
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1521996 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Communicable Diseases
Item
ongoing active infection.
boolean
C0009450 (UMLS CUI [1])
Antilipemic agent Changed
Item
change in treatment with lipid-lowering agent within 7 days of screening visit.
boolean
C0086440 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Anticoagulant therapy Requirement Expected | Aspirin Low Dose Excluded | Plavix Dosage Excluded
Item
current or expected requirement for anticoagulant therapy [except for low-dose aspirin ≤ 325 mg/d or plavix® ≤ 75 mg/d].
boolean
C0150457 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C2608320 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0633084 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
Phenytoin Expected
Item
current or expected treatment with phenytoin for the duration of the study.
boolean
C0031507 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
allergy to nonsteroidal anti-inflammatory agents
Item
known hypersensitivity to nsaids.
boolean
C0746949 (UMLS CUI [1])