Age
Item
male/female, age 18-78 inclusive
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Glargine Dose Stable | Metformin Dose Stable | Thiazolidinediones Dose Stable
Item
type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening
boolean
C0011860 (UMLS CUI [1])
C0907402 (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])
C1257987 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Glycosylated hemoglobin A
Item
hba1c 7.0-8.5% inclusive
boolean
C0019018 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose <240 mg/dl at screening
boolean
C0583513 (UMLS CUI [1])
Body mass index
Item
body mass index 22-41 kg/m2
boolean
C1305855 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
other investigational drugs within 30 days of screening
boolean
C0013230 (UMLS CUI [1])
Antidiabetics | Metformin | Glargine | Thiazolidinediones
Item
treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione
boolean
C0935929 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0907402 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent
Item
history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Abnormal renal function
Item
abnormal kidney function
boolean
C0151746 (UMLS CUI [1])
Complications of Diabetes Mellitus
Item
history of acute diabetic complications
boolean
C0342257 (UMLS CUI [1])
Congestive heart failure Treatment required for
Item
congestive heart failure requiring treatment
boolean
C0018802 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Cerebrovascular accident
Item
myocardial infarction, coronary artery surgery, stroke within 6 months of screening
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Liver diseases | Elevated liver enzymes
Item
liver disease, liver enzymes more than 3 times upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
Serum fasting triglyceride measurement
Item
fasting triglycerides >700 mg/dl within past 12 weeks
boolean
C0582824 (UMLS CUI [1])
Communicable Diseases Affecting Blood Glucose | Communicable Diseases Interfere with Interpretation research data | Condition Affecting Blood Glucose | Condition Interferes with Interpretation research data
Item
acute infections or other conditions that may affect blood sugar or may interfere with interpretation of study data
boolean
C0009450 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005802 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0681873 (UMLS CUI [4,4])
Adrenal Cortex Hormones
Item
treatment with corticosteroids
boolean
C0001617 (UMLS CUI [1])
Blood Donation
Item
blood donation within past 12 weeks
boolean
C0005794 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criterial may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])