Informed Consent
Item
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject)
boolean
C0021430 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus diagnosed for at least 12 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c value between 7% and 10.5% (both inclusive) at screening
boolean
C0202054 (UMLS CUI [1])
Insulin regime
Item
any insulin treatment for at least 3 months prior to screening
boolean
C0557978 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi): 25 - 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Antidiabetics Oral
Item
use of any oral antidiabetic agent within the past 6 months
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Heart Diseases | Chronic heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction Treated | Myocardial Infarction untreated
Item
cardiac disease: nyha class iii or iv chronic heart failure (chf), unstable angina, and/or any myocardial infarction (treated or untreated) within 6 months prior to screening
boolean
C0018799 (UMLS CUI [1])
C0264716 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
hepatic insufficiency (alt or ast greater than or equal to 2 times the central laboratory's upper reference limit)
boolean
C1306571 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
renal insufficiency (serum creatinine greater than or equal to 1.6 mg/dl for males; greater than or equal to
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Recurrent hypoglycemia | Loss of hypoglycemic warning
Item
recurrent hypoglycaemia or hypoglycaemic unawareness
boolean
C1846288 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Anemia | Hemoglobin measurement | Gender
Item
anaemia (haemoglobin less than 13.0 mg/dl in males and less than 12.0 mg/dl in females) (who criteria)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Pharmaceutical Preparations Systemic Changing Glucose metabolism | Topical preparations prescribed Changing Glucose metabolism | Non-Prescription Drugs Systemic Changing Glucose metabolism | Non-Prescription Drugs Topical Changing Glucose metabolism | Exception Insulin | Glucocorticoids, Systemic | Glucocorticoids Inhalation | Anabolic steroids | Non-selective beta-blocking agent
Item
use of any systemic or topical medications (prescribed or non-prescribed) which may alter glucose metabolism (other than insulin products), including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
boolean
C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0596620 (UMLS CUI [1,4])
C2367813 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C0013231 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0392747 (UMLS CUI [3,3])
C0596620 (UMLS CUI [3,4])
C0013231 (UMLS CUI [4,1])
C1710439 (UMLS CUI [4,2])
C0392747 (UMLS CUI [4,3])
C0596620 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
C3540777 (UMLS CUI [6])
C0017710 (UMLS CUI [7,1])
C0205535 (UMLS CUI [7,2])
C0002845 (UMLS CUI [8])
C0304515 (UMLS CUI [9])
Substance Use Disorders | Urine drug screen positive | Alcohol consumption Alcohol units/week
Item
history of substance (e.g. drugs, alcohol) abuse or a positive result in the urine drug/alcohol screen or consumption of more than 14 units (women) or 21 units (men) of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, one glass of wine, or 20 ml spirits)
boolean
C0038586 (UMLS CUI [1])
C0743300 (UMLS CUI [2])
C0001948 (UMLS CUI [3,1])
C0560579 (UMLS CUI [3,2])
Tobacco use Number of cigarettes per day | Refrain from Smoking Unable
Item
smoking of more than 20 cigarettes per day and inability to refrain from smoking during the in-house period
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Hepatitis | Hepatitis B surface antigen positive | Hepatitis C antibody test positive | HIV antibody positive
Item
known hepatitis or positive serological tests for the hepatitis b surface antigen (hbsag) or hepatitis c antibodies or hiv antibodies
boolean
C0019158 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1277805 (UMLS CUI [3])
C0920548 (UMLS CUI [4])
Uncontrolled hypertension Treated | Uncontrolled hypertension untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated/untreated hypertension (systolic blood pressure greater than or equal to 160 mmhg and/or diastolic blood pressure greater than or equal to 95 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])