ID

38710

Descrição

Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01475734

Link

https://clinicaltrials.gov/show/NCT01475734

Palavras-chave

Versões (1)
  1. 30/10/2019 30/10/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

30 de outubro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01475734

Inglês

Eligibility Diabetes Mellitus, Type 2 NCT01475734

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before screening
Descrição

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c <10% at screening for subjects who do not require washout of existing oad or <9% at screening for subjects who do require washout from existing oad
Descrição

Hemoglobin A1c measurement | Absence Washout Antidiabetics Oral | Washout Antidiabetics Oral

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1710661
UMLS CUI [2,3]
C0935929
UMLS CUI [2,4]
C1527415
UMLS CUI [3,1]
C1710661
UMLS CUI [3,2]
C0935929
UMLS CUI [3,3]
C1527415
body mass index in range 28 kg/m2 to40 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis
Descrição

History of pancreatitis | Gall Bladder Disease Symptomatic | Pancreatitis Symptomatic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3887021
UMLS CUI [2,1]
C0016977
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0030305
UMLS CUI [3,2]
C0231220
history of significant gastrointestinal surgery,
Descrição

Gastrointestinal Surgical Procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524722
history of significant cardiovascular disease
Descrição

Cardiovascular Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
history of a seizure disorder
Descrição

Epilepsy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0014544
documented hypertension or hypotension
Descrição

Hypertensive disease | Hypotension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0020649
use of oral antidiabetic agents, except for metformin, within 14 days before investigational product administration.
Descrição

Antidiabetics Oral | Exception Metformin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
current hepatic disease or abnormal liver function tests
Descrição

Liver disease | Liver function tests abnormal finding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151766
positive test result for hepatitis b, hepatitis c, or human immunodeficiency virus infection 1 or 2
Descrição

Hepatitis B test positive | Hepatitis C test positive | HIV-1 test positive | HIV-2 test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1608966
UMLS CUI [2]
C1609517
UMLS CUI [3]
C1328593
UMLS CUI [4]
C1168371
history of regular alcohol consumption (exceeding 7 drinks/week for women or 14 drinks/week for men)
Descrição

Alcohol consumption Regular | Alcoholic drinks per week | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0001967
UMLS CUI [2,2]
C0332174
UMLS CUI [3]
C0079399
female subject is pregnant (confirmed by laboratory testing), lactating, or less than 6 weeks postpartum
Descrição

Pregnancy | Breast Feeding | Postpartum Period

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0086839
known allergy to any glp-1 analog or excipients of albiglutide, baker's yeast, or insulin
Descrição

Hypersensitivity GLP-1 Analogue | Hypersensitivity Albiglutide Excipient | Hypersensitivity Saccharomyces cerevisiae | Insulin allergy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3273809
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2607479
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0036025
UMLS CUI [4]
C0571622
history of type 1 diabetes,
Descrição

Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
prior exposure to glp-1 agents, including albiglutide
Descrição

Exposure to GLP-1 Receptor Agonist | Exposure to Albiglutide

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C2917359
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C2607479
blood donation over 500 ml within 8 weeks before screening
Descrição

Blood Donation Amount Timespan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01475734

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement | Absence Washout Antidiabetics Oral | Washout Antidiabetics Oral
Item
hba1c <10% at screening for subjects who do not require washout of existing oad or <9% at screening for subjects who do require washout from existing oad
boolean
C0474680 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C1710661 (UMLS CUI [2,2])
C0935929 (UMLS CUI [2,3])
C1527415 (UMLS CUI [2,4])
C1710661 (UMLS CUI [3,1])
C0935929 (UMLS CUI [3,2])
C1527415 (UMLS CUI [3,3])
Body mass index
Item
body mass index in range 28 kg/m2 to40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
History of pancreatitis | Gall Bladder Disease Symptomatic | Pancreatitis Symptomatic
Item
history of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis
boolean
C3887021 (UMLS CUI [1])
C0016977 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0030305 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
Gastrointestinal Surgical Procedure
Item
history of significant gastrointestinal surgery,
boolean
C0524722 (UMLS CUI [1])
Cardiovascular Disease
Item
history of significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Epilepsy
Item
history of a seizure disorder
boolean
C0014544 (UMLS CUI [1])
Hypertensive disease | Hypotension
Item
documented hypertension or hypotension
boolean
C0020538 (UMLS CUI [1])
C0020649 (UMLS CUI [2])
Antidiabetics Oral | Exception Metformin
Item
use of oral antidiabetic agents, except for metformin, within 14 days before investigational product administration.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Liver disease | Liver function tests abnormal finding
Item
current hepatic disease or abnormal liver function tests
boolean
C0023895 (UMLS CUI [1])
C0151766 (UMLS CUI [2])
Hepatitis B test positive | Hepatitis C test positive | HIV-1 test positive | HIV-2 test positive
Item
positive test result for hepatitis b, hepatitis c, or human immunodeficiency virus infection 1 or 2
boolean
C1608966 (UMLS CUI [1])
C1609517 (UMLS CUI [2])
C1328593 (UMLS CUI [3])
C1168371 (UMLS CUI [4])
Alcohol consumption Regular | Alcoholic drinks per week | Gender
Item
history of regular alcohol consumption (exceeding 7 drinks/week for women or 14 drinks/week for men)
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0001967 (UMLS CUI [2,1])
C0332174 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
Pregnancy | Breast Feeding | Postpartum Period
Item
female subject is pregnant (confirmed by laboratory testing), lactating, or less than 6 weeks postpartum
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0086839 (UMLS CUI [3])
Hypersensitivity GLP-1 Analogue | Hypersensitivity Albiglutide Excipient | Hypersensitivity Saccharomyces cerevisiae | Insulin allergy
Item
known allergy to any glp-1 analog or excipients of albiglutide, baker's yeast, or insulin
boolean
C0020517 (UMLS CUI [1,1])
C3273809 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2607479 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0036025 (UMLS CUI [3,2])
C0571622 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent
Item
history of type 1 diabetes,
boolean
C0011854 (UMLS CUI [1])
Exposure to GLP-1 Receptor Agonist | Exposure to Albiglutide
Item
prior exposure to glp-1 agents, including albiglutide
boolean
C0332157 (UMLS CUI [1,1])
C2917359 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C2607479 (UMLS CUI [2,2])
Blood Donation Amount Timespan
Item
blood donation over 500 ml within 8 weeks before screening
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
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