Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise
Item
have type 2 diabetes and are treated with diet and exercise alone.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
Age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c between 7.1% and 11.0%, inclusive.
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of 23 kg/m2 to 45 kg/m2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Stable body weight | Variability Percentage Timespan
Item
have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
boolean
C0517386 (UMLS CUI [1])
C2827666 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Heart Disease | Myocardial Infarction | Cardiac Arrhythmia | Angina, Unstable | Congestive heart failure Moderate | Congestive heart failure Severe | Coronary Artery Bypass Surgery | Angioplasty
Item
ave history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C0018802 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0010055 (UMLS CUI [7])
C0162577 (UMLS CUI [8])
Kidney Transplantation | Dialysis
Item
have a history of renal transplantation or are currently receiving renal dialysis
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Malignant Neoplasms | Malignant Neoplasm Untreated | Cancer Remission | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of prostate
Item
have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0687702 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0154088 (UMLS CUI [7,2])
Gastrointestinal Disease Severe | Gastroparesis
Item
have history of severe gi disorder (e.g., gastroparesis)
boolean
C0017178 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0152020 (UMLS CUI [2])
Pancreatitis | Pancreatitis, Chronic
Item
have a history of acute or chronic pancreatitis.
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Proliferative retinopathy
Item
have active proliferative retinopathy.
boolean
C0339467 (UMLS CUI [1])
Weight-Loss Agents | Xenical | orlistat | Meridia | sibutramine | Acomplia | rimonabant | Phenylpropanolamine
Item
have been treated with drugs that promote weight loss (e.g., xenical®[orlistat], meridia® [sibutramine], acomplia® [rimonabant], acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
boolean
C0376606 (UMLS CUI [1])
C0732649 (UMLS CUI [2])
C0076275 (UMLS CUI [3])
C0635898 (UMLS CUI [4])
C0074493 (UMLS CUI [5])
C2002731 (UMLS CUI [6])
C1142933 (UMLS CUI [7])
C0031495 (UMLS CUI [8])
Antidiabetics
Item
have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
boolean
C0935929 (UMLS CUI [1])
Organ Transplantation
Item
have had an organ transplant.
boolean
C0029216 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drug Completed | Investigational New Drug Discontinued | Patient withdrawn from trial | exenatide
Item
have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0422727 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
Pharmaceutical Preparation Approval Lacking
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C0013227 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Study Subject Participation Status
Item
are currently enrolled in any other clinical study.
boolean
C2348568 (UMLS CUI [1])