ID

30604

Beschrijving

A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01028404

Link

https://clinicaltrials.gov/show/NCT01028404

Trefwoorden

Versies (2)
  1. 17-06-18 17-06-18 -
  2. 27-09-21 27-09-21 -
Houder van rechten

see clinicaltrials.gov

Geüploaded op

17 juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT01028404

Engels

Eligibility Diabetes NCT01028404

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01028404
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
for trial part 1, the following applies:
Beschrijving

ID.1

Datatype

boolean

gender: male
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
age: 18-55 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
bmi (body mass index): 18-28 kg/m2
Beschrijving

Body Mass Index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
study participants considered to be healthy
Beschrijving

Healthy Volunteers

Datatype

boolean

Alias
UMLS CUI [1]
C1708335
for trial part 2, the following applies:
Beschrijving

ID.6

Datatype

boolean

gender: male or female of no childbearing potential
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
age: 18-65 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
type 1 diabetes: bmi (body mass index): 18-28 kg/m2
Beschrijving

Diabetes Mellitus, Insulin-Dependent; Body mass index

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C1305855
type 2 diabetes: bmi (body mass index): 22-35 kg/m2
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent; Body mass index

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1305855
type 1 or type 2 diabetes for at least 12 months
Beschrijving

Diabetes Mellitus, Insulin-Dependent, Duration; Diabetes Mellitus, Non-Insulin-Dependent, Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0449238
type 1 diabetes: treatment with insulin for at least 12 months
Beschrijving

Diabetes Mellitus, Insulin-Dependent; insulin treatment, Duration of therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0745343
UMLS CUI [1,3]
C0444917
type 2 diabetes: treatment with insulin for at least 3 months
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent; insulin treatment, Duration of therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0745343
UMLS CUI [1,3]
C0444917
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to the trial product or related products
Beschrijving

Hypersensitivity clinical trial drug; Hypersensitivity Pharmaceutical Preparations Relationships

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3854006
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing nn1952, as judged by the investigator
Beschrijving

Illness, Interferes with research results; Communicable Diseases, Interferes with research results; Illness, patient safety At risk; Communicable Diseases, patient safety At risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C1113679
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C1113679
UMLS CUI [4,3]
C1444641
presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)
Beschrijving

Gastrointestinal symptom Present

Datatype

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0150312
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Similar models

Eligibility Diabetes NCT01028404

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01028404
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
for trial part 1, the following applies:
boolean
Gender
Item
gender: male
boolean
C0079399 (UMLS CUI [1])
Age
Item
age: 18-55 years
boolean
C0001779 (UMLS CUI [1])
Body Mass Index
Item
bmi (body mass index): 18-28 kg/m2
boolean
C1305855 (UMLS CUI [1])
Healthy Volunteers
Item
study participants considered to be healthy
boolean
C1708335 (UMLS CUI [1])
ID.6
Item
for trial part 2, the following applies:
boolean
Gender
Item
gender: male or female of no childbearing potential
boolean
C0079399 (UMLS CUI [1])
Age
Item
age: 18-65 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent; Body mass index
Item
type 1 diabetes: bmi (body mass index): 18-28 kg/m2
boolean
C0011854 (UMLS CUI [1,1])
C1305855 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent; Body mass index
Item
type 2 diabetes: bmi (body mass index): 22-35 kg/m2
boolean
C0011860 (UMLS CUI [1,1])
C1305855 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent, Duration; Diabetes Mellitus, Non-Insulin-Dependent, Duration
Item
type 1 or type 2 diabetes for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent; insulin treatment, Duration of therapy
Item
type 1 diabetes: treatment with insulin for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0745343 (UMLS CUI [1,2])
C0444917 (UMLS CUI [1,3])
Diabetes Mellitus, Non-Insulin-Dependent; insulin treatment, Duration of therapy
Item
type 2 diabetes: treatment with insulin for at least 3 months
boolean
C0011860 (UMLS CUI [1,1])
C0745343 (UMLS CUI [1,2])
C0444917 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity clinical trial drug; Hypersensitivity Pharmaceutical Preparations Relationships
Item
known or suspected allergy to the trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Illness, Interferes with research results; Communicable Diseases, Interferes with research results; Illness, patient safety At risk; Communicable Diseases, patient safety At risk
Item
presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing nn1952, as judged by the investigator
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C1113679 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0009450 (UMLS CUI [4,1])
C1113679 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
Gastrointestinal symptom Present
Item
presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)
boolean
C0426576 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
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