Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes mellitus prior to entering the trial.
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Exercise
Item
are currently being treated with diet and exercise therapy consistent with the local standards of medical care.
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
Diet therapy | Exercise | Metformin Dosage Stable | Combined Modality Therapy
Item
may be treated with diet and exercise alone or in combination with a stable of metformin for at least 3 month before entering the trial.
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0009429 (UMLS CUI [4])
Glucohemoglobin measurement
Item
have a hemoglobin a1c value between 7.0% and 10.0 %, inclusive.
boolean
C0202054 (UMLS CUI [1])
Gender Childbearing Potential Absent | Female Sterilization | Hysterectomy | Bilateral oophorectomy | Tubal Ligation | Menopause | Gender Contraceptive methods | Partner Childbearing Potential
Item
are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. male patients will be advised to use a reliable method of birth control during the study and until 3 months after the last dose of study medication if their partner is of child-bearing potential.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0015787 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0278321 (UMLS CUI [4])
C0520483 (UMLS CUI [5])
C0025320 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C0682323 (UMLS CUI [8,1])
C3831118 (UMLS CUI [8,2])
Insulin | Antidiabetics Except Metformin
Item
use of insulin or any antidiabetic agent other than metformin during the 3 months prior entering the trial.
boolean
C0021641 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0025598 (UMLS CUI [2,3])
Gastrointestinal Diseases Impact Gastric Emptying | Gastrointestinal Diseases Impact Gastric motility | Gastroparesis Severe | Pyloric Stenosis | Gastric Bypass | Gastric band Operative Surgical Procedures
Item
have a gastrointestinal disease that significantly impacts gastric emptying or motility (for example, severe gastroparesis or pyloric stenosis), in the opinion of the investigator, or have undergone gastric bypass or gastric banding 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])
C0152020 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0034194 (UMLS CUI [4])
C0017125 (UMLS CUI [5])
C3854330 (UMLS CUI [6,1])
C0543467 (UMLS CUI [6,2])
Hypoglycemia Severe Episode Quantity | Loss of hypoglycemic warning
Item
have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0342317 (UMLS CUI [2])
Emergency department patient visit Quantity Due to Poor glycemic control | Hospitalization Quantity Due to Poor glycemic control
Item
have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
boolean
C0586082 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0342299 (UMLS CUI [1,4])
C0019993 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0342299 (UMLS CUI [2,4])
Signs Cardiac autonomic neuropathy | Symptoms Cardiac autonomic neuropathy | Cardiac autonomic neuropathy Diagnostic tests | TACHYCARDIA REST | Hypotension, Orthostatic
Item
have cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing.
boolean
C0311392 (UMLS CUI [1,1])
C1740787 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C1740787 (UMLS CUI [2,2])
C1740787 (UMLS CUI [3,1])
C0086143 (UMLS CUI [3,2])
C0749248 (UMLS CUI [4])
C0020651 (UMLS CUI [5])
Heart Disease New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | CONGESTIVE HEART FAILURE DECOMPENSATED
Item
have cardiac disease with functional status that is new york heart association class ii, iii or iv or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 month.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0742746 (UMLS CUI [4])
Poor hypertension control | Systolic Pressure mean | Diastolic blood pressure mean | Malignant Hypertension | Renal Artery Stenosis | Labile blood pressure | Postural Hypotension Symptomatic | Antihypertensive Agents Dose Stable
Item
have poorly controlled hypertension (that is, mean systolic blood pressure of greater or equal than 160 mm hg or mean diastolic blood pressure of greater or equal than 100 mm hg) history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. doses of antihypertensive medications must be stable for 30 days before randomization.
boolean
C0421190 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C0020540 (UMLS CUI [4])
C0035067 (UMLS CUI [5])
C0428895 (UMLS CUI [6])
C0020651 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0003364 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0205360 (UMLS CUI [8,3])
Hypertriglyceridemia result | Hypertriglyceridemia result Fasting | Hypoglycemic Agents Dose Stable
Item
have fed or fasting state hypertriglyceridemia (defined as >6.8 millimoles per liter [mmol/l], 600 milligrams per deciliter [mg/dl]) at screening. if taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
boolean
C1522137 (UMLS CUI [1])
C1522137 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
C0020616 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Sign or Symptom Liver disease | Hepatitis | Hepatitis, Chronic | Alanine aminotransferase increased Repeated
Item
have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or repeated alanine transaminase (alt) levels >2.5 times the upper limit of the reference range at screening.
boolean
C3540840 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0019158 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
C0151905 (UMLS CUI [4,1])
C0205341 (UMLS CUI [4,2])
Abnormality of the endocrine system Uncontrolled | Autoimmune Diseases Uncontrolled
Item
have evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator at screening.
boolean
C4025823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Malignant Neoplasms | Malignant Neoplasms untreated | Cancer in 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 an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal 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])
Epilepsy
Item
have a history of seizure disorder.
boolean
C0014544 (UMLS CUI [1])