ID

33732

Description

A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01981031

Link

https://clinicaltrials.gov/show/NCT01981031

Keywords

Versions (1)
  1. 12/21/18 12/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01981031

English

Eligibility Diabetes NCT01981031

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01981031
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus for at least (or equal to ) 12 months,
Description

Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
Description

Insulin injection Multiple Daily | Insulin pump Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0332173
UMLS CUI [2,1]
C1140609
UMLS CUI [2,2]
C0087111
body mass index (bmi): 18.0-28.0kg/m2 (both inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 2 diabetes mellitus,
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
the receipt of any investigational product within 3 month prior to first dosing,
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
clinically significant abnormalities, as judged by the investigator,
Description

Abnormality Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
any systemic treatment with drugs known to interfere with glucose metabolism,
Description

Systemic therapy | Pharmaceutical Preparations Interfere with Glucose metabolism

Data type

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0596620
history of alcoholism or drug/chemical abuse and any tobacco product within 5 years prior to screening
Description

Alcoholic Intoxication, Chronic | Drug and chemical abuse | Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0851847
UMLS CUI [3]
C0543414
blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
Description

Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount

Data type

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0005794
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0032105
UMLS CUI [4,2]
C0005794
UMLS CUI [4,3]
C1265611
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Similar models

Eligibility Diabetes NCT01981031

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01981031
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus for at least (or equal to ) 12 months,
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection Multiple Daily | Insulin pump Treatment
Item
treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C1140609 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Body mass index
Item
body mass index (bmi): 18.0-28.0kg/m2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus,
boolean
C0011860 (UMLS CUI [1])
Investigational New Drugs
Item
the receipt of any investigational product within 3 month prior to first dosing,
boolean
C0013230 (UMLS CUI [1])
Abnormality Clinical Significance
Item
clinically significant abnormalities, as judged by the investigator,
boolean
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Systemic therapy | Pharmaceutical Preparations Interfere with Glucose metabolism
Item
any systemic treatment with drugs known to interfere with glucose metabolism,
boolean
C1515119 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
Alcoholic Intoxication, Chronic | Drug and chemical abuse | Tobacco use
Item
history of alcoholism or drug/chemical abuse and any tobacco product within 5 years prior to screening
boolean
C0001973 (UMLS CUI [1])
C0851847 (UMLS CUI [2])
C0543414 (UMLS CUI [3])
Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount
Item
blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0005794 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
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