ID

38844

Description

A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00813020

Link

https://clinicaltrials.gov/show/NCT00813020

Keywords

Versions (1)
  1. 11/9/19 11/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00813020

English

Eligibility Diabetes NCT00813020

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00813020
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the investigator
Description

Gender | Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C3898900
UMLS CUI [3,2]
C0031809
UMLS CUI [4,1]
C3898900
UMLS CUI [4,2]
C1254595
body weight between 80 kg and 110 kg (both inclusive)
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
body mass index (bmi) between 18 and 27 kg/m2, both inclusive
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
fasting plasma glucose max 108 mg/dl (6.0 mmol/l)
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to trial product(s) or related products
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
previous participation in this trial (randomisation)
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
the receipt of any investigational medicinal product within 3 months prior to this trial
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
subjects who have had a clinically relevant illness within 4 weeks of dosing
Description

Illness Relevance Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
history of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
Description

Malignant Neoplasms | Diabetes Mellitus | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Hematological Disease | Dermatologic disorders | Sexually Transmitted Diseases | Nervous system disorder | Mental disorders | Disease Major

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0035204
UMLS CUI [5]
C0025517
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0017178
UMLS CUI [9]
C0014130
UMLS CUI [10]
C0018939
UMLS CUI [11]
C0037274
UMLS CUI [12]
C0036916
UMLS CUI [13]
C0027765
UMLS CUI [14]
C0004936
UMLS CUI [15,1]
C0012634
UMLS CUI [15,2]
C0205164
regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period
Description

Tobacco use Regular Number of cigarettes per day | Tobacco use Amount Equivalent | Refrain from Smoking Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C3694146
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205163
UMLS CUI [3,1]
C4086797
UMLS CUI [3,2]
C1299582
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Similar models

Eligibility Diabetes NCT00813020

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00813020
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Results
Item
healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the investigator
boolean
C0079399 (UMLS CUI [1])
C3898900 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C3898900 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C3898900 (UMLS CUI [4,1])
C1254595 (UMLS CUI [4,2])
Body Weight
Item
body weight between 80 kg and 110 kg (both inclusive)
boolean
C0005910 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 18 and 27 kg/m2, both inclusive
boolean
C1305855 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose max 108 mg/dl (6.0 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | 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])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Study Subject Participation Status
Item
previous participation in this trial (randomisation)
boolean
C2348568 (UMLS CUI [1])
Investigational New Drugs
Item
the receipt of any investigational medicinal product within 3 months prior to this trial
boolean
C0013230 (UMLS CUI [1])
Illness Relevance Clinical
Item
subjects who have had a clinically relevant illness within 4 weeks of dosing
boolean
C0221423 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Malignant Neoplasms | Diabetes Mellitus | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Hematological Disease | Dermatologic disorders | Sexually Transmitted Diseases | Nervous system disorder | Mental disorders | Disease Major
Item
history of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
boolean
C0006826 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0037274 (UMLS CUI [11])
C0036916 (UMLS CUI [12])
C0027765 (UMLS CUI [13])
C0004936 (UMLS CUI [14])
C0012634 (UMLS CUI [15,1])
C0205164 (UMLS CUI [15,2])
Tobacco use Regular Number of cigarettes per day | Tobacco use Amount Equivalent | Refrain from Smoking Unable
Item
regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period
boolean
C0543414 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C3694146 (UMLS CUI [1,3])
C0543414 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C4086797 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
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