body weight
Item
body weight ≥50 kg.
boolean
C0005910 (UMLS CUI [1])
suboptimal glycemic control, hba1c, diet modification and exercise or treated with oral antidiabetics, hba1c, oral antidiabetics including alpha glucosidase inhibitor or meglitinide
Item
have suboptimal glycemic control as evidenced by an hba1c defined by the following criteria: *6.5% to 10.0%, inclusive, at study start for patients managed with diet modification and exercise or treated with oral antidiabetics drug but not alpha glucosidase inhibitor or meglitinide derivatives; *6.5% to 9.5%, inclusive, at study start for patients treated with oral antidiabetics including alpha glucosidase inhibitor or meglitinide derivatives.
boolean
C0342299 (UMLS CUI [1])
C0202054 (UMLS CUI [2,1])
C0086153 (UMLS CUI [2,2])
C0015259 (UMLS CUI [2,3])
C0359086 (UMLS CUI [2,4])
C0202054 (UMLS CUI [3,1])
C0359086 (UMLS CUI [3,2])
C0332257 (UMLS CUI [3,3])
C1299007 (UMLS CUI [3,4])
C0065880 (UMLS CUI [3,5])
diet modification and exercise, stable regimen of oral antidiabetic drugs
Item
have been treated with diet modification and exercise alone or in combination with a stable regimen of oral antidiabetic drugs (sulfonylurea, metformin and thiazolidinedione) for at least 2 months prior to study start.
boolean
C0086153 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
concomitant therapy with alpha glucosidase inhibitors or meglitinide derivatives, discontinuation
Item
the patients with concomitant use of alpha glucosidase inhibitors (glucobay® [acarbose], basen® [voglibose], or seibule®[miglitol]) or meglitinide derivatives (glufast® [mitiglinide] or fastic®/starsis® [nateglinide]) can be included in this study, but these drugs must be discontinued after confirmation of eligibility at study start.
boolean
C1707479 (UMLS CUI [1,1])
C1299007 (UMLS CUI [1,2])
C0065880 (UMLS CUI [1,3])
C4288399 (UMLS CUI [1,4])
concomitant use of sulfonylurea, drug dose
Item
in the case of patients with concomitant use of sulfonylurea, the dose of sulfonylurea must not be more than maximum recommended dose.
text
C1707479 (UMLS CUI [1,1])
C3536898 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
blood donation, volume
Item
subjects who have donated more than 200 ml of blood and component blood donation within one month of study start, or those who have donated more than 400 ml of blood within three months of study start.
boolean
C0005794 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
concomitant therapy, pharmaceutical preparations
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
C1707479 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
exenatide, glp-1 analogs, study subject participation status
Item
have participated and received at least one dose of exenatide or other glp-1 analogs in this study previously, or any other study using exenatide or other glp-1 analogs.
boolean
C0167117 (UMLS CUI [1,1])
C3273809 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
exogenous insulin
Item
are treated with any exogenous insulin within 3 months of screening.
boolean
C0205228 (UMLS CUI [1,1])
C0745343 (UMLS CUI [1,2])
drugs that directly affect gastrointestinal motility, Domperidone; Metoclopramide; itopride; Cisapride; mosapride; Trimebutine
Item
are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *drugs that directly affect gastrointestinal motility, including nauzelin® (domperidone), primperan®/terperan® (metoclopramide), ganaton® (itopride), acenalin® (cisapride), gasmotin® (mosapride), or cerekinon® (trimebutine).
boolean
C0017184 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013015 (UMLS CUI [1,3])
C0025853 (UMLS CUI [1,4])
C0531483 (UMLS CUI [1,5])
C0072916 (UMLS CUI [1,6])
C0526501 (UMLS CUI [1,7])
C0041023 (UMLS CUI [1,8])
breastfeeding, gender
Item
females who are breastfeeding.
boolean
C0006147 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])