ID

35807

Description

Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function; ODM derived from: https://clinicaltrials.gov/show/NCT02443155

Link

https://clinicaltrials.gov/show/NCT02443155

Keywords

Versions (1)
  1. 3/25/19 3/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02443155

English

Eligibility Diabetes NCT02443155

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02443155
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
t1dm (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 12 weeks prior to randomisation
Description

Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
non-fasting c-peptide higher or equal to 0.2 nmol/l
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
bmi (body mass index) higher or equal to 18.5 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (gad), islet antigen-2 (ia2) or zinc-transporter 8 (znt8)) at screening
Description

Glutamic Acid Decarboxylase Antibody | Anti-IA2 antibody | Anti-ZnT8 antibody

Data type

boolean

Alias
UMLS CUI [1]
C0443891
UMLS CUI [2]
C3203592
UMLS CUI [3]
C3203614
insulin dependence unless in temporary spontaneous remission (honeymoon period)
Description

Insulin Dependence | Exception Temporary Spontaneous Remission

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0439857
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0035053
UMLS CUI [2,3]
C0205374
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
daily insulin usage above 1 u/kg per day at screening or use of continuous subcutaneous insulin infusion (csii)
Description

Insulin use Unit/kilogram/day | Continuous subcutaneous infusion of insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0240016
UMLS CUI [1,2]
C1532634
UMLS CUI [2]
C0393124
history of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis)
Description

Communicable Diseases Severe Recurrent | Chronic infectious disease Recurrent | Recurrent pneumonia | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945760
UMLS CUI [2,1]
C0151317
UMLS CUI [2,2]
C2945760
UMLS CUI [3]
C0694550
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0231203
UMLS CUI [4,3]
C0151317
UMLS CUI [5]
C0006267
UMLS CUI [6]
C0008707
history of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy
Description

Systemic mycosis Severe | Exception Resolution

Data type

boolean

Alias
UMLS CUI [1,1]
C0553576
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1514893
vaccination within 4 weeks before randomisation, visit 3 (v3)
Description

Vaccination

Data type

boolean

Alias
UMLS CUI [1]
C0042196
receipt of any other concomitant medications or herbal products that can influence the glucose homeostasis (except for insulin) and/or the immune system within 90 days prior to screening (v1)
Description

Pharmaceutical Preparations Influence Glucose homeostasis | Herbal product Influence Glucose homeostasis | Exception Insulin | Pharmaceutical Preparations Influence Immune system | Herbal product Influence Immune system

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C1326961
UMLS CUI [2,1]
C2240391
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C1326961
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0021641
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C0020962
UMLS CUI [5,1]
C2240391
UMLS CUI [5,2]
C4054723
UMLS CUI [5,3]
C0020962
history of pancreatitis (acute or chronic)
Description

Pancreatitis | Pancreatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
family or personal history of multiple endocrine neoplasia type 2 (men2) or medullary thyroid carcinoma (mtc)
Description

Family history of multiple endocrine neoplasia Type | Multiple Endocrine Neoplasia Type | Familial medullary thyroid carcinoma | Medullary carcinoma of thyroid

Data type

boolean

Alias
UMLS CUI [1,1]
C4039247
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C0027662
UMLS CUI [2,2]
C0332307
UMLS CUI [3]
C1833921
UMLS CUI [4]
C0238462
any past or current diagnosis of malignant neoplasms
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
known impairment of the immune system, except for t1dm
Description

Immune system Impairment | Exception Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0020962
UMLS CUI [1,2]
C0221099
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011854
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Similar models

Eligibility Diabetes NCT02443155

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02443155
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
t1dm (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 12 weeks prior to randomisation
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form
boolean
C0001779 (UMLS CUI [1])
C-peptide measurement
Item
non-fasting c-peptide higher or equal to 0.2 nmol/l
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) higher or equal to 18.5 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Glutamic Acid Decarboxylase Antibody | Anti-IA2 antibody | Anti-ZnT8 antibody
Item
presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (gad), islet antigen-2 (ia2) or zinc-transporter 8 (znt8)) at screening
boolean
C0443891 (UMLS CUI [1])
C3203592 (UMLS CUI [2])
C3203614 (UMLS CUI [3])
Insulin Dependence | Exception Temporary Spontaneous Remission
Item
insulin dependence unless in temporary spontaneous remission (honeymoon period)
boolean
C0021641 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0035053 (UMLS CUI [2,2])
C0205374 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Insulin use Unit/kilogram/day | Continuous subcutaneous infusion of insulin
Item
daily insulin usage above 1 u/kg per day at screening or use of continuous subcutaneous insulin infusion (csii)
boolean
C0240016 (UMLS CUI [1,1])
C1532634 (UMLS CUI [1,2])
C0393124 (UMLS CUI [2])
Communicable Diseases Severe Recurrent | Chronic infectious disease Recurrent | Recurrent pneumonia | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis
Item
history of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis)
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C0151317 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0694550 (UMLS CUI [3])
C0348080 (UMLS CUI [4,1])
C0231203 (UMLS CUI [4,2])
C0151317 (UMLS CUI [4,3])
C0006267 (UMLS CUI [5])
C0008707 (UMLS CUI [6])
Systemic mycosis Severe | Exception Resolution
Item
history of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy
boolean
C0553576 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
Vaccination
Item
vaccination within 4 weeks before randomisation, visit 3 (v3)
boolean
C0042196 (UMLS CUI [1])
Pharmaceutical Preparations Influence Glucose homeostasis | Herbal product Influence Glucose homeostasis | Exception Insulin | Pharmaceutical Preparations Influence Immune system | Herbal product Influence Immune system
Item
receipt of any other concomitant medications or herbal products that can influence the glucose homeostasis (except for insulin) and/or the immune system within 90 days prior to screening (v1)
boolean
C0013227 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C1326961 (UMLS CUI [1,3])
C2240391 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C1326961 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C0020962 (UMLS CUI [4,3])
C2240391 (UMLS CUI [5,1])
C4054723 (UMLS CUI [5,2])
C0020962 (UMLS CUI [5,3])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Family history of multiple endocrine neoplasia Type | Multiple Endocrine Neoplasia Type | Familial medullary thyroid carcinoma | Medullary carcinoma of thyroid
Item
family or personal history of multiple endocrine neoplasia type 2 (men2) or medullary thyroid carcinoma (mtc)
boolean
C4039247 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0027662 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1833921 (UMLS CUI [3])
C0238462 (UMLS CUI [4])
Malignant Neoplasms
Item
any past or current diagnosis of malignant neoplasms
boolean
C0006826 (UMLS CUI [1])
Immune system Impairment | Exception Insulin-Dependent Diabetes Mellitus
Item
known impairment of the immune system, except for t1dm
boolean
C0020962 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0011854 (UMLS CUI [2,2])
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