Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes mellitus for at least 6 months prior to entering the trial.
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Exercise | Combined Modality Therapy | Metformin U/day
Item
treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening.
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0025598 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
Glucohemoglobin measurement
Item
have a glycosylated fraction of hemoglobin a (hba1c) value of 7.0% - 10.0% at screening
boolean
C0202054 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity
Item
women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Body mass index
Item
have a body mass index (bmi) between 25 and 40 kilograms per square meters kg/m^2) at screening
boolean
C1305855 (UMLS CUI [1])
Stable body weight Duration
Item
stable weight during the 3 months prior to screening.
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Antidiabetics | Exception Metformin
Item
use any antidiabetic agent other than metformin during the 2 months prior to screening.
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Gastrointestinal Disease Impact Gastric Emptying | Gastrointestinal Disease Impact Gastric motility | Bariatric Surgery
Item
have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery.
boolean
C0017178 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0017127 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0232572 (UMLS CUI [2,3])
C1456587 (UMLS CUI [3])
Weight-Loss Agents | Non-Prescription Drugs Weight loss
Item
are currently taking prescription or over-the counter medications to promote weight loss.
boolean
C0376606 (UMLS CUI [1])
C0013231 (UMLS CUI [2,1])
C1262477 (UMLS CUI [2,2])
Pancreatitis
Item
have been previously diagnosed with pancreatitis
boolean
C0030305 (UMLS CUI [1])
Breast Feeding
Item
women who are breastfeeding.
boolean
C0006147 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Transient Ischemic Attack | Cerebrovascular accident | CONGESTIVE HEART FAILURE DECOMPENSATED
Item
have a history of myocardial infarction, unstable angina, coronary artery bypass graft (cabg), percutaneous coronary intervention, transient ischemic attack, stroke or decompensated congestive heart failure in the past 6 months.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0742746 (UMLS CUI [7])
Poor hypertension control
Item
have poorly controlled hypertension
boolean
C0421190 (UMLS CUI [1])