ID

23952

Beschrijving

An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00516048

Link

https://clinicaltrials.gov/show/NCT00516048

Trefwoorden

  1. 19-07-17 19-07-17 -
Geüploaded op

19 juli 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT00516048

Eligibility Type 2 Diabetes Mellitus NCT00516048

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes.
Beschrijving

ID.1

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
have been exposed to exenatide for at least 3 months in previous amylin/lilly studies h8o-mc-gwao, h8o-mc-gwap, h8o-mc-gwat, or h8o-mc-gwba.
Beschrijving

ID.2

Datatype

boolean

Alias
UMLS CUI [1]
C0167117
have interrupted exenatide treatment for a period of at least 2 months.
Beschrijving

ID.3

Datatype

boolean

Alias
UMLS CUI [1]
C0167117
hba1c of ≤10.5%.
Beschrijving

ID.4

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Beschrijving

ID.5

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0087111
have previously completed or withdrawn from this study.
Beschrijving

ID.6

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348557
UMLS CUI [1,2]
C2348571
have taken marketed exenatide (byetta) during the interim period between studies gwao, gwap, gwat, or gwba and the current study.
Beschrijving

ID.7

Datatype

boolean

Alias
UMLS CUI [1,1]
C1636686
UMLS CUI [1,2]
C0087111
used drugs for weight loss (for example, xenical® [orlistat], meridia® [sibutramine], acutrim® [phenylpropanolamine], accomplia® [rimonabant], or similar over-the-counter medications) within 3 months of screening.
Beschrijving

ID.8

Datatype

boolean

Alias
UMLS CUI [1]
C0376606
are currently treated with any of the following excluded medications: drugs that directly affect gastrointestinal motility, including, but not limited to: reglan®
Beschrijving

ID.9

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034977
UMLS CUI [1,2]
C0017184
(metoclopramide), propulsid® (cisapride), and chronic macrolide antibiotics.
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025853
UMLS CUI [1,2]
C0722861
UMLS CUI [1,3]
C0003240
use insulin with daily dosage exceeding 1 u/kg.
Beschrijving

ID.11

Datatype

boolean

Alias
UMLS CUI [1]
C0021641

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00516048

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
diagnosed with type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
ID.2
Item
have been exposed to exenatide for at least 3 months in previous amylin/lilly studies h8o-mc-gwao, h8o-mc-gwap, h8o-mc-gwat, or h8o-mc-gwba.
boolean
C0167117 (UMLS CUI [1])
ID.3
Item
have interrupted exenatide treatment for a period of at least 2 months.
boolean
C0167117 (UMLS CUI [1])
ID.4
Item
hba1c of ≤10.5%.
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.5
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
C0087111 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
ID.6
Item
have previously completed or withdrawn from this study.
boolean
C2348557 (UMLS CUI [1,1])
C2348571 (UMLS CUI [1,2])
ID.7
Item
have taken marketed exenatide (byetta) during the interim period between studies gwao, gwap, gwat, or gwba and the current study.
boolean
C1636686 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
ID.8
Item
used drugs for weight loss (for example, xenical® [orlistat], meridia® [sibutramine], acutrim® [phenylpropanolamine], accomplia® [rimonabant], or similar over-the-counter medications) within 3 months of screening.
boolean
C0376606 (UMLS CUI [1])
ID.9
Item
are currently treated with any of the following excluded medications: drugs that directly affect gastrointestinal motility, including, but not limited to: reglan®
boolean
C0034977 (UMLS CUI [1,1])
C0017184 (UMLS CUI [1,2])
ID.10
Item
(metoclopramide), propulsid® (cisapride), and chronic macrolide antibiotics.
boolean
C0025853 (UMLS CUI [1,1])
C0722861 (UMLS CUI [1,2])
C0003240 (UMLS CUI [1,3])
ID.11
Item
use insulin with daily dosage exceeding 1 u/kg.
boolean
C0021641 (UMLS CUI [1])

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