ID

20770

Beschreibung

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec; ODM derived from: https://clinicaltrials.gov/show/NCT01865279

Link

https://clinicaltrials.gov/show/NCT01865279

Stichworte

Versionen (1)
  1. 16.03.17 16.03.17 -
Hochgeladen am

16. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes NCT01865279

Englisch

Eligibility Diabetes NCT01865279

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01865279
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy subjects:
Beschreibung

Healthy Volunteers

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
subjects will be healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the investigator
Beschreibung

Gender Healthy | Medical History | Physical Examination | Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3898900
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C1254595
body mass index (bmi) between 18.0-27.0 kg/m^2 (both inclusive)
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
subjects with type 1 and type 2 diabetes:
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
subjects will be male volunteers, who are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the investigator
Beschreibung

Gender Healthy Volunteers | Medical History | Physical Examination | Laboratory Results | Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1708335
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C1254595
UMLS CUI [5]
C0011849
diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months or diagnosed with type 2 diabetes mellitus for at least 12 months
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Insulin | Non-Insulin-Dependent Diabetes Mellitus disease length

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0021641
UMLS CUI [3,1]
C0011860
UMLS CUI [3,2]
C0872146
body mass index (bmi) between 18.0-27.0 kg/m^2 (both inclusive) for subjects with type 1 diabetes or 25.0-35.0 kg/m^2 (both inclusive) for subjects with type 2 diabetes
Beschreibung

Body mass index Insulin-Dependent Diabetes Mellitus | Body mass index Non-Insulin-Dependent Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C0011854
UMLS CUI [2,1]
C1305855
UMLS CUI [2,2]
C0011860
glycogylated haemoglobin (hba1c) maximum 8.5 % based on central laboratory results
Beschreibung

Glycosylated hemoglobin A Percentage Maximum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0806909
subjects with type 2 diabetes must have been treated with insulin for the past 3 months prior to screening
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0021641
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in any other trials involving investigational products within 3 months preceding the start of dosing
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
history of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator
Beschreibung

Drug Allergy multiple | Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparation Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0439064
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
hepatitis or carrier of the hepatitis b surface antigen (hbsag) or hepatitis c antibodies or a positive result to the test for human immunodeficiency (hiv) antibodies
Beschreibung

Hepatitis | Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0281863
UMLS CUI [4]
C0920548
any clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator
Beschreibung

Hematology finding abnormal | Abnormal biochemistry finding

Datentyp

boolean

Alias
UMLS CUI [1]
C0475182
UMLS CUI [2]
C0586680
subjects who have donated any blood or plasma in the past month or in excess of 1000 ml within the 12 weeks preceding screening
Beschreibung

Blood Donation Recent | Plasma donor Recent | Blood Donation Quantity | Plasma donor Plasma Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0860067
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0860067
UMLS CUI [4,2]
C0032105
UMLS CUI [4,3]
C1265611
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Ähnliche Modelle

Eligibility Diabetes NCT01865279

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01865279
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers
Item
healthy subjects:
boolean
C1708335 (UMLS CUI [1])
Gender Healthy | Medical History | Physical Examination | Laboratory Results
Item
subjects will be healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the investigator
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C1254595 (UMLS CUI [4])
Body mass index
Item
body mass index (bmi) between 18.0-27.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
subjects with type 1 and type 2 diabetes:
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Gender Healthy Volunteers | Medical History | Physical Examination | Laboratory Results | Diabetes Mellitus
Item
subjects will be male volunteers, who are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the investigator
boolean
C0079399 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C1254595 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
Diabetes Mellitus, Insulin-Dependent | Insulin | Non-Insulin-Dependent Diabetes Mellitus disease length
Item
diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months or diagnosed with type 2 diabetes mellitus for at least 12 months
boolean
C0011854 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0011860 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
Body mass index Insulin-Dependent Diabetes Mellitus | Body mass index Non-Insulin-Dependent Diabetes Mellitus
Item
body mass index (bmi) between 18.0-27.0 kg/m^2 (both inclusive) for subjects with type 1 diabetes or 25.0-35.0 kg/m^2 (both inclusive) for subjects with type 2 diabetes
boolean
C1305855 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C1305855 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Glycosylated hemoglobin A Percentage Maximum
Item
glycogylated haemoglobin (hba1c) maximum 8.5 % based on central laboratory results
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Diabetes Mellitus, Non-Insulin-Dependent | Insulin
Item
subjects with type 2 diabetes must have been treated with insulin for the past 3 months prior to screening
boolean
C0011860 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs
Item
participation in any other trials involving investigational products within 3 months preceding the start of dosing
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Drug Allergy multiple | Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparation Related
Item
history of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator
boolean
C0013182 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
Hepatitis | Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive
Item
hepatitis or carrier of the hepatitis b surface antigen (hbsag) or hepatitis c antibodies or a positive result to the test for human immunodeficiency (hiv) antibodies
boolean
C0019158 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0281863 (UMLS CUI [3])
C0920548 (UMLS CUI [4])
Hematology finding abnormal | Abnormal biochemistry finding
Item
any clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator
boolean
C0475182 (UMLS CUI [1])
C0586680 (UMLS CUI [2])
Blood Donation Recent | Plasma donor Recent | Blood Donation Quantity | Plasma donor Plasma Quantity
Item
subjects who have donated any blood or plasma in the past month or in excess of 1000 ml within the 12 weeks preceding screening
boolean
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0860067 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0860067 (UMLS CUI [4,1])
C0032105 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
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