ID

38922

Beskrivning

A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01513473

Länk

https://clinicaltrials.gov/show/NCT01513473

Nyckelord

Versioner (1)
  1. 2019-11-13 2019-11-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 november 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT01513473

Engelsk

Eligibility Diabetes NCT01513473

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01513473
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent, and child assent as age-appropriate, obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject). the parents or legal representative of the child must sign and date the informed consent form according to local requirements. the child, if possible, parents or legal representative of the child must sign and date the child assent form according to local requirements
Beskrivning

Informed Consent | Assent Child | Informed Consent Parent | Informed Consent Patient Representative | Assent Child Parent | Assent Child Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1879749
UMLS CUI [2,2]
C0008059
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030551
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0030701
UMLS CUI [5,1]
C1879749
UMLS CUI [5,2]
C0008059
UMLS CUI [5,3]
C0030551
UMLS CUI [6,1]
C1879749
UMLS CUI [6,2]
C0008059
UMLS CUI [6,3]
C0030701
male or female diagnosed with type 1 diabetes mellitus (t1dm) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
ongoing daily treatment with insulin (any regimen) for at least 3 months prior to visit 1 (screening). no oads (oral anti-diabetic drugs) are allowed
Beskrivning

Insulin regime | Antidiabetics Oral Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0332197
hba1c (glycosylated haemoglobin) maximum 11%
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected hypersensitivity to trial product(s) or related products
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datatyp

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]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
previous participation in this trial. participation is defined as randomisation
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
girls who are pregnant, breastfeeding or intend to become pregnant
Beskrivning

Pregnancy | Breast Feeding | Pregnancy intended

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
girls who have had menarche and are not using adequate contraceptive measures according to local requirements
Beskrivning

Menarche Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025274
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator (trial physician)
Beskrivning

Loss of hypoglycemic warning | Hypoglycaemic episode Severe Recurrent

Datatyp

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2945760
more than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to visit 1
Beskrivning

Diabetic Ketoacidosis Quantity | Hospitalization Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011880
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1708385
significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion could interfere with the trial
Beskrivning

Comorbidity Interferes with Clinical Trial | Exception Condition Associated with Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0011854
the receipt of any investigational drug within 1 month prior to visit 1
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Diabetes NCT01513473

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01513473
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Assent Child | Informed Consent Parent | Informed Consent Patient Representative | Assent Child Parent | Assent Child Patient Representative
Item
informed consent, and child assent as age-appropriate, obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject). the parents or legal representative of the child must sign and date the informed consent form according to local requirements. the child, if possible, parents or legal representative of the child must sign and date the child assent form according to local requirements
boolean
C0021430 (UMLS CUI [1])
C1879749 (UMLS CUI [2,1])
C0008059 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0030551 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
C1879749 (UMLS CUI [5,1])
C0008059 (UMLS CUI [5,2])
C0030551 (UMLS CUI [5,3])
C1879749 (UMLS CUI [6,1])
C0008059 (UMLS CUI [6,2])
C0030701 (UMLS CUI [6,3])
Diabetes Mellitus, Insulin-Dependent
Item
male or female diagnosed with type 1 diabetes mellitus (t1dm) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
boolean
C0011854 (UMLS CUI [1])
Insulin regime | Antidiabetics Oral Absent
Item
ongoing daily treatment with insulin (any regimen) for at least 3 months prior to visit 1 (screening). no oads (oral anti-diabetic drugs) are allowed
boolean
C0557978 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) maximum 11%
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to trial product(s) or related products
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])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Study Subject Participation Status
Item
previous participation in this trial. participation is defined as randomisation
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy intended
Item
girls who are pregnant, breastfeeding or intend to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
Menarche Contraceptive methods Absent
Item
girls who have had menarche and are not using adequate contraceptive measures according to local requirements
boolean
C0025274 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Loss of hypoglycemic warning | Hypoglycaemic episode Severe Recurrent
Item
known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator (trial physician)
boolean
C0342317 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945760 (UMLS CUI [2,3])
Diabetic Ketoacidosis Quantity | Hospitalization Required
Item
more than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to visit 1
boolean
C0011880 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1708385 (UMLS CUI [2])
Comorbidity Interferes with Clinical Trial | Exception Condition Associated with Insulin-Dependent Diabetes Mellitus
Item
significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion could interfere with the trial
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0011854 (UMLS CUI [2,4])
Investigational New Drugs
Item
the receipt of any investigational drug within 1 month prior to visit 1
boolean
C0013230 (UMLS CUI [1])
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