ID

20760

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01511692

Nyckelord

Versioner (1)
  1. 2017-03-15 2017-03-15 -
Uppladdad den

15 mars 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Diabetes NCT01511692

Engelsk

Eligibility Diabetes NCT01511692

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01511692
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
diet-treated subjects and/or subjects with type 2 diabetes in oad (oral anti-diabetic drug) mono-therapy
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

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)
Beskrivning

Body mass index

Datatyp

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)
Beskrivning

Stable body weight | Body Weight Screening procedure

Datatyp

boolean

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

Euthyroid

Datatyp

boolean

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

Eating normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0566568
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
recurrent severe hypoglycaemia
Beskrivning

Recurrent severe hypoglycemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0342316
impaired liver function
Beskrivning

Liver Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
impaired renal function
Beskrivning

Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
cardiac problems
Beskrivning

cardiac problem

Datatyp

boolean

Alias
UMLS CUI [1]
C0262402
uncontrolled treated/untreated hypertension
Beskrivning

Uncontrolled hypertension Treated | Uncontrolled hypertension untreated

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Hepatitis B | Hepatitis C

Datatyp

boolean

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

HIV antibody positive

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

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

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Diabetes NCT01511692

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01511692
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial