ID

22878

Description

A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00612794

Link

https://clinicaltrials.gov/show/NCT00612794

Keywords

Versions (1)
  1. 6/13/17 6/13/17 -
Uploaded on

June 13, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00612794

English

Eligibility Type 2 Diabetes NCT00612794

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body weight ≥50 kg.
Description

body weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
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.
Description

suboptimal glycemic control, hba1c, diet modification and exercise or treated with oral antidiabetics, hba1c, oral antidiabetics including alpha glucosidase inhibitor or meglitinide

Data type

boolean

Alias
UMLS CUI [1]
C0342299
UMLS CUI [2,1]
C0202054
UMLS CUI [2,2]
C0086153
UMLS CUI [2,3]
C0015259
UMLS CUI [2,4]
C0359086
UMLS CUI [3,1]
C0202054
UMLS CUI [3,2]
C0359086
UMLS CUI [3,3]
C0332257
UMLS CUI [3,4]
C1299007
UMLS CUI [3,5]
C0065880
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.
Description

diet modification and exercise, stable regimen of oral antidiabetic drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0086153
UMLS CUI [1,2]
C0015259
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0205360
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.
Description

concomitant therapy with alpha glucosidase inhibitors or meglitinide derivatives, discontinuation

Data type

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C1299007
UMLS CUI [1,3]
C0065880
UMLS CUI [1,4]
C4288399
in the case of patients with concomitant use of sulfonylurea, the dose of sulfonylurea must not be more than maximum recommended dose.
Description

concomitant use of sulfonylurea, drug dose

Data type

text

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C3536898
UMLS CUI [1,3]
C0678766
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Description

blood donation, volume

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0449468
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.
Description

concomitant therapy, pharmaceutical preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0013227
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.
Description

exenatide, glp-1 analogs, study subject participation status

Data type

boolean

Alias
UMLS CUI [1,1]
C0167117
UMLS CUI [1,2]
C3273809
UMLS CUI [1,3]
C2348568
are treated with any exogenous insulin within 3 months of screening.
Description

exogenous insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0205228
UMLS CUI [1,2]
C0745343
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).
Description

drugs that directly affect gastrointestinal motility, Domperidone; Metoclopramide; itopride; Cisapride; mosapride; Trimebutine

Data type

boolean

Alias
UMLS CUI [1,1]
C0017184
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0013015
UMLS CUI [1,4]
C0025853
UMLS CUI [1,5]
C0531483
UMLS CUI [1,6]
C0072916
UMLS CUI [1,7]
C0526501
UMLS CUI [1,8]
C0041023
females who are breastfeeding.
Description

breastfeeding, gender

Data type

boolean

Alias
UMLS CUI [1,1]
C0006147
UMLS CUI [1,2]
C0079399
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Similar models

Eligibility Type 2 Diabetes NCT00612794

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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