ID

42094

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00516074

Nyckelord

Versioner (2)
  1. 2017-07-19 2017-07-19 -
  2. 2021-04-08 2021-04-08 - Ahmed Rafee, MD
Rättsinnehavare

AR

Uppladdad den

8 april 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00516074

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00516074

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes.
Beskrivning

ID.1

Datatyp

boolean

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

ID.2

Datatyp

boolean

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

ID.3

Datatyp

boolean

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

ID.4

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

ID.5

Datatyp

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.
Beskrivning

ID.6

Datatyp

boolean

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

ID.7

Datatyp

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.
Beskrivning

ID.8

Datatyp

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.
Beskrivning

ID.9

Datatyp

boolean

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

ID.10

Datatyp

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.
Beskrivning

ID.11

Datatyp

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])
Beskrivning

ID.12

Datatyp

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.
Beskrivning

ID.13

Datatyp

boolean

Alias
UMLS CUI [1]
C0005795
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00516074

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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