ID

42094

Descrição

A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00516074

Link

https://clinicaltrials.gov/show/NCT00516074

Palavras-chave

Versões (2)
  1. 19/07/2017 19/07/2017 -
  2. 08/04/2021 08/04/2021 - Ahmed Rafee, MD
Titular dos direitos

AR

Transferido a

8 de abril de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00516074

Inglês

Eligibility Type 2 Diabetes Mellitus NCT00516074

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes.
Descrição

ID.1

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
treated with metformin and/or a thiazolidinedione.
Descrição

ID.2

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C1257987
hba1c between 6.5% and 9.5%, inclusive.
Descrição

ID.3

Tipo de dados

boolean

body mass index (bmi) > 25 kg/m^2 and < 40 kg/m^2.
Descrição

ID.4

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
have previously received exenatide or glucagon-like peptide-1 analogs.
Descrição

ID.5

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0167117
UMLS CUI [1,2]
C0061355
have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
Descrição

ID.6

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348577
receiving beta blockers.
Descrição

ID.7

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001645
receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to reglan® (metoclopramide), propulsid® (cisapride), and chronic macrolide antibiotics.
Descrição

ID.8

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0017184
UMLS CUI [1,2]
C0722861
UMLS CUI [1,3]
C0034977
UMLS CUI [1,4]
C0003240
have received treatment with systemic glucocorticoid therapy by oral, intravenous (iv), or intramuscular (im) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators.
Descrição

ID.9

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0017710
have been treated with drugs that promote weight loss (for example, adipex®
Descrição

ID.10

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0376606
[phentermine], acomplia® [rimonabant], xenical® [orlistat], meridia® [sibutramine], acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
Descrição

ID.11

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031447
UMLS CUI [1,2]
C1142933
UMLS CUI [1,3]
C0076275
UMLS CUI [1,4]
C0074493
UMLS CUI [1,5]
C0031495
have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: *insulin; *alpha-glucosidase inhibitors (for example, glyset® [miglitol] or precose® [acarbose]); *meglitinides (for example, prandin® [repaglinide] or starlix® [nateglinide]); *sulfonylureas (for example, glucotrol® [glipizide] or micronase® [glyburide]); *dipeptidyl peptidase iv (dpp-iv) inhibitors (for example, januvia™ [sitagliptin])
Descrição

ID.12

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1299007
UMLS CUI [1,3]
C0065880
UMLS CUI [1,4]
C0038766
UMLS CUI [1,5]
C0081937
have donated blood within 60 days of screening.
Descrição

ID.13

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005795
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00516074

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
diagnosed with type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
ID.2
Item
treated with metformin and/or a thiazolidinedione.
boolean
C0025598 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
ID.3
Item
hba1c between 6.5% and 9.5%, inclusive.
boolean
ID.4
Item
body mass index (bmi) > 25 kg/m^2 and < 40 kg/m^2.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.5
Item
have previously received exenatide or glucagon-like peptide-1 analogs.
boolean
C0167117 (UMLS CUI [1,1])
C0061355 (UMLS CUI [1,2])
ID.6
Item
have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
boolean
C2348577 (UMLS CUI [1])
ID.7
Item
receiving beta blockers.
boolean
C0001645 (UMLS CUI [1])
ID.8
Item
receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to reglan® (metoclopramide), propulsid® (cisapride), and chronic macrolide antibiotics.
boolean
C0017184 (UMLS CUI [1,1])
C0722861 (UMLS CUI [1,2])
C0034977 (UMLS CUI [1,3])
C0003240 (UMLS CUI [1,4])
ID.9
Item
have received treatment with systemic glucocorticoid therapy by oral, intravenous (iv), or intramuscular (im) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators.
boolean
C0017710 (UMLS CUI [1])
ID.10
Item
have been treated with drugs that promote weight loss (for example, adipex®
boolean
C0376606 (UMLS CUI [1])
ID.11
Item
[phentermine], acomplia® [rimonabant], xenical® [orlistat], meridia® [sibutramine], acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
boolean
C0031447 (UMLS CUI [1,1])
C1142933 (UMLS CUI [1,2])
C0076275 (UMLS CUI [1,3])
C0074493 (UMLS CUI [1,4])
C0031495 (UMLS CUI [1,5])
ID.12
Item
have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: *insulin; *alpha-glucosidase inhibitors (for example, glyset® [miglitol] or precose® [acarbose]); *meglitinides (for example, prandin® [repaglinide] or starlix® [nateglinide]); *sulfonylureas (for example, glucotrol® [glipizide] or micronase® [glyburide]); *dipeptidyl peptidase iv (dpp-iv) inhibitors (for example, januvia™ [sitagliptin])
boolean
C0021641 (UMLS CUI [1,1])
C1299007 (UMLS CUI [1,2])
C0065880 (UMLS CUI [1,3])
C0038766 (UMLS CUI [1,4])
C0081937 (UMLS CUI [1,5])
ID.13
Item
have donated blood within 60 days of screening.
boolean
C0005795 (UMLS CUI [1])
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