ID

20765

Descrição

Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01517555

Link

https://clinicaltrials.gov/show/NCT01517555

Palavras-chave

Versões (2)
  1. 15/03/2017 15/03/2017 -
  2. 15/03/2017 15/03/2017 -
Transferido a

15 de março de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Eligibility Diabetes NCT01517555

Inglês

Eligibility Diabetes NCT01517555

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01517555
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus
Descrição

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
diet-treated subjects with type 2 diabetes with hba1c 7.5-9.5 %
Descrição

Diet therapy Non-Insulin-Dependent Diabetes Mellitus | Glycosylated hemoglobin A Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012159
UMLS CUI [1,2]
C0011860
UMLS CUI [2,1]
C0019018
UMLS CUI [2,2]
C0439165
subjects with type 2 diabetes in oral anti-diabetic drug (oad) monotherapy treated with metformin or alpha-glucosidase inhibitors with hba1c 7.0-9.5%
Descrição

Antidiabetics Oral Non-Insulin-Dependent Diabetes Mellitus | Metformin | alpha-Glucosidase Inhibitors | Glycosylated hemoglobin A Percent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0011860
UMLS CUI [2]
C0025598
UMLS CUI [3]
C1299007
UMLS CUI [4,1]
C0019018
UMLS CUI [4,2]
C0439165
body mass index (bmi) 18.5-40 kg/m^2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
subjects should have a stable body weight for at least 3 months prior to screening (as judged by the investigator)
Descrição

Stable body weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0517386
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
impaired liver function
Descrição

Liver Dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086565
impaired renal function
Descrição

Renal Insufficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
clinically significant active cardiovascular disease including history of myocardial infarction within the last 6 months and/or heart failure
Descrição

Cardiovascular Diseases | Myocardial Infarction | Heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018801
any clinically significant abnormal ecg (electrocardiogram)
Descrição

Electrocardiogram abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0522055
uncontrolled treated/untreated hypertension
Descrição

Uncontrolled hypertension Treated | Uncontrolled hypertension untreated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
recurrent severe hypoglycaemia as judged by the investigator
Descrição

Recurrent severe hypoglycemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0342316
active hepatitis b and/or active hepatitis c
Descrição

Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
positive human immunodeficiency virus (hiv) antibodies
Descrição

HIV antibody positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920548
known or suspected allergy to trial product(s) or related products
Descrição

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C0013230
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
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Similar models

Eligibility Diabetes NCT01517555

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01517555
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Diet therapy Non-Insulin-Dependent Diabetes Mellitus | Glycosylated hemoglobin A Percentage
Item
diet-treated subjects with type 2 diabetes with hba1c 7.5-9.5 %
boolean
C0012159 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C0019018 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Antidiabetics Oral Non-Insulin-Dependent Diabetes Mellitus | Metformin | alpha-Glucosidase Inhibitors | Glycosylated hemoglobin A Percent
Item
subjects with type 2 diabetes in oral anti-diabetic drug (oad) monotherapy treated with metformin or alpha-glucosidase inhibitors with hba1c 7.0-9.5%
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
C1299007 (UMLS CUI [3])
C0019018 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) 18.5-40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Stable body weight
Item
subjects should have a stable body weight for at least 3 months prior to screening (as judged by the investigator)
boolean
C0517386 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver Dysfunction
Item
impaired liver function
boolean
C0086565 (UMLS CUI [1])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Cardiovascular Diseases | Myocardial Infarction | Heart failure
Item
clinically significant active cardiovascular disease including history of myocardial infarction within the last 6 months and/or heart failure
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
Electrocardiogram abnormal
Item
any clinically significant abnormal ecg (electrocardiogram)
boolean
C0522055 (UMLS CUI [1])
Uncontrolled hypertension Treated | Uncontrolled hypertension untreated
Item
uncontrolled treated/untreated hypertension
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Recurrent severe hypoglycemia
Item
recurrent severe hypoglycaemia as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
active hepatitis b and/or active hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV antibody positive
Item
positive human immunodeficiency virus (hiv) antibodies
boolean
C0920548 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
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