ID

37396

Description

Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02455076

Link

https://clinicaltrials.gov/show/NCT02455076

Keywords

Versions (1)
  1. 7/22/19 7/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02455076

English

Eligibility Type 2 Diabetes NCT02455076

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age < 18 or > 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
9. patients with unstable or rapidly progressing renal disease or severe renal impairment (creatinine clearance < 30 ml/min)
Description

Kidney Disease Unstable | Kidney Disease Rapidly progressive | Renal Insufficiency Severe | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C1838681
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0373595
10. patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease),
Description

Liver disease | Liver Cirrhosis | Icterus | End Stage Liver Disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0022346
UMLS CUI [4]
C0745744
11. history of hypersensitivity to exenatide
Description

Hypersensitivity Exenatide

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0167117
13. patients with history of heavy alcohol use (female > 2 drinks per day, male > 3 drinks per day) or drug abuse within 3 months prior to admission.
Description

Heavy alcohol use Drinks per day | Gender | Drug abuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0687132
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0439505
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0013146
14. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Description

Mental handicap | Study Protocol Comprehension Unable

Data type

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C1299582
15. female subjects who are pregnant or breast feeding at time of enrollment into the study.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Type 2 Diabetes NCT02455076

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age < 18 or > 80 years
boolean
C0001779 (UMLS CUI [1])
Kidney Disease Unstable | Kidney Disease Rapidly progressive | Renal Insufficiency Severe | Creatinine clearance measurement
Item
9. patients with unstable or rapidly progressing renal disease or severe renal impairment (creatinine clearance < 30 ml/min)
boolean
C0022658 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C1838681 (UMLS CUI [2,2])
C1565489 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0373595 (UMLS CUI [4])
Liver disease | Liver Cirrhosis | Icterus | End Stage Liver Disease
Item
10. patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease),
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0022346 (UMLS CUI [3])
C0745744 (UMLS CUI [4])
Hypersensitivity Exenatide
Item
11. history of hypersensitivity to exenatide
boolean
C0020517 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
Heavy alcohol use Drinks per day | Gender | Drug abuse
Item
13. patients with history of heavy alcohol use (female > 2 drinks per day, male > 3 drinks per day) or drug abuse within 3 months prior to admission.
boolean
C0687132 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
C0013146 (UMLS CUI [3])
Mental handicap | Study Protocol Comprehension Unable
Item
14. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
boolean
C1306341 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
15. female subjects who are pregnant or breast feeding at time of enrollment into the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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