ID

29255

Description

Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01464099

Link

https://clinicaltrials.gov/show/NCT01464099

Keywords

Versions (1)
  1. 3/12/18 3/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01464099

English

Eligibility Diabetes NCT01464099

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01464099
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 1 diabetes treated with insulin for at least 12 months
Description

Insulin-Dependent Diabetes Mellitus Disease length | Insulin regime

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0557978
bmi (body mass index) between 18.0-29.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
negative fasting c-peptide (below or equal to 0.6 ng/ml)
Description

Fasting C-peptide level Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C2208720
UMLS CUI [1,2]
C1513916
hba1c (glycosylated haemoglobin a1c) below or equal to 10.0%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
current treatment with insulin below or equal to 1.2 u/kg/day
Description

Insulin regime Unit/kilogram/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C1532634
subject should be in good health based on medical history, physical examination and routine laboratory data
Description

Good health Medical History | Good health Physical Examination | Good health Laboratory Results

Data type

boolean

Alias
UMLS CUI [1,1]
C3813622
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3813622
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C3813622
UMLS CUI [3,2]
C1254595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any known/suspected allergies to trial medication or similar products/devices
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Suspected Pharmaceutical Preparations Similar | Hypersensitivity Investigational Medical Device Similar | Hypersensitivity Suspected Investigational Medical Device Similar

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]
C2348205
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C2348205
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C2346570
UMLS CUI [5,3]
C2348205
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C2346570
UMLS CUI [6,4]
C2348205
a subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator
Description

Proliferative retinopathy | Disorder of macula of retina | Neuropathy Severe | Autonomic neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2]
C0730362
UMLS CUI [3,1]
C0442874
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0259749
clinically significant active disease of any kind
Description

Disease Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the investigator
Description

Recurrent severe hypoglycemia | Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
blood donation (more than 500 ml) within the previous 9 weeks
Description

Blood Donation Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
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Similar models

Eligibility Diabetes NCT01464099

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01464099
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length | Insulin regime
Item
subjects with type 1 diabetes treated with insulin for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2])
Body mass index
Item
bmi (body mass index) between 18.0-29.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Fasting C-peptide level Negative
Item
negative fasting c-peptide (below or equal to 0.6 ng/ml)
boolean
C2208720 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin a1c) below or equal to 10.0%
boolean
C0202054 (UMLS CUI [1])
Insulin regime Unit/kilogram/day
Item
current treatment with insulin below or equal to 1.2 u/kg/day
boolean
C0557978 (UMLS CUI [1,1])
C1532634 (UMLS CUI [1,2])
Good health Medical History | Good health Physical Examination | Good health Laboratory Results
Item
subject should be in good health based on medical history, physical examination and routine laboratory data
boolean
C3813622 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3813622 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3813622 (UMLS CUI [3,1])
C1254595 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Suspected Pharmaceutical Preparations Similar | Hypersensitivity Investigational Medical Device Similar | Hypersensitivity Suspected Investigational Medical Device Similar
Item
any known/suspected allergies to trial medication or similar products/devices
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])
C2348205 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C2348205 (UMLS CUI [4,4])
C0020517 (UMLS CUI [5,1])
C2346570 (UMLS CUI [5,2])
C2348205 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C2346570 (UMLS CUI [6,3])
C2348205 (UMLS CUI [6,4])
Proliferative retinopathy | Disorder of macula of retina | Neuropathy Severe | Autonomic neuropathy
Item
a subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2])
C0442874 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0259749 (UMLS CUI [4])
Disease Clinical Significance
Item
clinically significant active disease of any kind
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Blood Donation Quantity
Item
blood donation (more than 500 ml) within the previous 9 weeks
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
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