ID

20760

Descrição

Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01511692

Link

https://clinicaltrials.gov/show/NCT01511692

Palavras-chave

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

15 de março de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT01511692

Inglês

Eligibility Diabetes NCT01511692

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01511692
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 and/or subjects with type 2 diabetes in oad (oral anti-diabetic drug) mono-therapy
Descrição

Diet therapy Non-Insulin-Dependent Diabetes Mellitus | Antidiabetics Oral Non-Insulin-Dependent Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012159
UMLS CUI [1,2]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0011860
hba1c for diet-treated subjects: hba1c between 6.5-10.0% (both inclusive) and for oad treated subjects: hba1c between 6.5-9.5% (both inclusive)
Descrição

Glycosylated hemoglobin A Percentage Diet therapy | Glycosylated hemoglobin A Percentage Antidiabetics Oral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0012159
UMLS CUI [2,1]
C0019018
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0935929
UMLS CUI [2,4]
C1527415
body mass index (bmi) between 27-40 kg/m^2 (both inclusive)
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 documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)
Descrição

Stable body weight | Body Weight Screening procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0517386
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C0220908
euthyroid subjects
Descrição

Euthyroid

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0117002
subjects should be unrestrained eaters
Descrição

Eating normal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0566568
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
recurrent severe hypoglycaemia
Descrição

Recurrent severe hypoglycemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0342316
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
cardiac problems
Descrição

cardiac problem

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0262402
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
known or suspected allergy to trial products 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
use of any drug (except for oads), which in the investigator's opinion could interfere with the subject's glucose level or body weight
Descrição

Pharmaceutical Preparation Interferes with Glucose level | Pharmaceutical Preparation Interferes with Body Weight | Antidiabetics Oral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0428548
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0005910
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
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 hiv (human immunodeficiency virus) antibodies
Descrição

HIV antibody positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920548
known or suspected abuse of alcohol or narcotics
Descrição

Alcohol abuse | Narcotic Abuse | Alcohol abuse Suspected | Narcotic Abuse Suspected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0524661
UMLS CUI [3,1]
C0085762
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0524661
UMLS CUI [4,2]
C0750491
habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the investigator
Descrição

Consumption Excessive Beverages methylxanthine | Consumption Excessive Food methylxanthine | Consumption Excessive Coffee | Consumption Excessive Tea | Consumption Excessive Cola drink | Consumption Excessive Hot chocolate drink

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C0005329
UMLS CUI [1,4]
C0066447
UMLS CUI [2,1]
C0009830
UMLS CUI [2,2]
C0442802
UMLS CUI [2,3]
C0016452
UMLS CUI [2,4]
C0066447
UMLS CUI [3,1]
C0009830
UMLS CUI [3,2]
C0442802
UMLS CUI [3,3]
C0009237
UMLS CUI [4,1]
C0009830
UMLS CUI [4,2]
C0442802
UMLS CUI [4,3]
C0039400
UMLS CUI [5,1]
C0009830
UMLS CUI [5,2]
C0442802
UMLS CUI [5,3]
C0452444
UMLS CUI [6,1]
C0009830
UMLS CUI [6,2]
C0442802
UMLS CUI [6,3]
C0452243
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Similar models

Eligibility Diabetes NCT01511692

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01511692
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 | Antidiabetics Oral Non-Insulin-Dependent Diabetes Mellitus
Item
diet-treated subjects and/or subjects with type 2 diabetes in oad (oral anti-diabetic drug) mono-therapy
boolean
C0012159 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,3])
Glycosylated hemoglobin A Percentage Diet therapy | Glycosylated hemoglobin A Percentage Antidiabetics Oral
Item
hba1c for diet-treated subjects: hba1c between 6.5-10.0% (both inclusive) and for oad treated subjects: hba1c between 6.5-9.5% (both inclusive)
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0012159 (UMLS CUI [1,3])
C0019018 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0935929 (UMLS CUI [2,3])
C1527415 (UMLS CUI [2,4])
Body mass index
Item
body mass index (bmi) between 27-40 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Stable body weight | Body Weight Screening procedure
Item
subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)
boolean
C0517386 (UMLS CUI [1])
C0005910 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
Euthyroid
Item
euthyroid subjects
boolean
C0117002 (UMLS CUI [1])
Eating normal
Item
subjects should be unrestrained eaters
boolean
C0566568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Recurrent severe hypoglycemia
Item
recurrent severe hypoglycaemia
boolean
C0342316 (UMLS CUI [1])
Liver Dysfunction
Item
impaired liver function
boolean
C0086565 (UMLS CUI [1])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
cardiac problem
Item
cardiac problems
boolean
C0262402 (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])
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 products 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])
Pharmaceutical Preparation Interferes with Glucose level | Pharmaceutical Preparation Interferes with Body Weight | Antidiabetics Oral
Item
use of any drug (except for oads), which in the investigator's opinion could interfere with the subject's glucose level or body weight
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0428548 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0005910 (UMLS CUI [2,3])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
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 hiv (human immunodeficiency virus) antibodies
boolean
C0920548 (UMLS CUI [1])
Alcohol abuse | Narcotic Abuse | Alcohol abuse Suspected | Narcotic Abuse Suspected
Item
known or suspected abuse of alcohol or narcotics
boolean
C0085762 (UMLS CUI [1])
C0524661 (UMLS CUI [2])
C0085762 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0524661 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Consumption Excessive Beverages methylxanthine | Consumption Excessive Food methylxanthine | Consumption Excessive Coffee | Consumption Excessive Tea | Consumption Excessive Cola drink | Consumption Excessive Hot chocolate drink
Item
habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the investigator
boolean
C0009830 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0005329 (UMLS CUI [1,3])
C0066447 (UMLS CUI [1,4])
C0009830 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
C0016452 (UMLS CUI [2,3])
C0066447 (UMLS CUI [2,4])
C0009830 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0009237 (UMLS CUI [3,3])
C0009830 (UMLS CUI [4,1])
C0442802 (UMLS CUI [4,2])
C0039400 (UMLS CUI [4,3])
C0009830 (UMLS CUI [5,1])
C0442802 (UMLS CUI [5,2])
C0452444 (UMLS CUI [5,3])
C0009830 (UMLS CUI [6,1])
C0442802 (UMLS CUI [6,2])
C0452243 (UMLS CUI [6,3])
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