ID

35807

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02443155

Nyckelord

Versioner (1)
  1. 2019-03-25 2019-03-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT02443155

Engelsk

Eligibility Diabetes NCT02443155

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02443155
Inclusion Criteria
Beskrivning

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
Beskrivning

Informed Consent

Datatyp

boolean

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

Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

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
Beskrivning

Age

Datatyp

boolean

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

C-peptide measurement

Datatyp

boolean

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

Body mass index

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Insulin Dependence | Exception Temporary Spontaneous Remission

Datatyp

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
Beskrivning

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)
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Systemic mycosis Severe | Exception Resolution

Datatyp

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)
Beskrivning

Vaccination

Datatyp

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)
Beskrivning

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

Datatyp

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)
Beskrivning

Pancreatitis | Pancreatitis, Chronic

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Malignant Neoplasms

Datatyp

boolean

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

Immune system Impairment | Exception Insulin-Dependent Diabetes Mellitus

Datatyp

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 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02443155
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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