ID

38993

Beschrijving

A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT02131272

Link

https://clinicaltrials.gov/show/NCT02131272

Trefwoorden

Versies (1)
  1. 18-11-19 18-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes NCT02131272

Engels

Eligibility Diabetes NCT02131272

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02131272
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent from the subject or a legally acceptable representative (lar) and child assent from the subject 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
Beschrijving

Informed Consent | Informed Consent Patient Representative | Child Assent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3,1]
C0008059
UMLS CUI [3,2]
C1879749
male or female, above or equal to 10 years and below or equal to 17 years at the time of signing informed consent/assent
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of type 2 diabetes mellitus at least 3 months prior to screening
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treated with the maximum tolerated stable dose of metformin for at least 3 months prior to screening or have documented complete metformin intolerance
Beschrijving

Metformin Maximum Tolerated Dose | Intolerance to Metformin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0752079
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025598
hba1c (glycosylated haemoglobin) above or equal to 7.0% and below or equal to 10.5% (above or equal to 53 mmol/mol and below or equal to 91 mmol/mol) at screening
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
maturity onset diabetes of the young (mody)
Beschrijving

Maturity onset diabetes mellitus in young

Datatype

boolean

Alias
UMLS CUI [1]
C0342276
fasting c-peptide at screening below 0.6 ng/ml
Beschrijving

Fasting C-peptide level

Datatype

boolean

Alias
UMLS CUI [1]
C2208720
impaired liver function defined as alanine aminotransferase (alt) above or equal to 2.5 times upper normal limit
Beschrijving

Liver Dysfunction | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
Beschrijving

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Datatype

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 3 months before the day of screening
Beschrijving

Pharmacotherapy Indication Diabetes Mellitus | Pharmacotherapy Indication Obesity | Exception Pharmaceutical Preparations Inclusion criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0011849
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C3146298
UMLS CUI [2,3]
C0028754
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C1512693
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Similar models

Eligibility Diabetes NCT02131272

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02131272
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Informed Consent Patient Representative | Child Assent
Item
informed consent from the subject or a legally acceptable representative (lar) and child assent from the subject 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])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0008059 (UMLS CUI [3,1])
C1879749 (UMLS CUI [3,2])
Age
Item
male or female, above or equal to 10 years and below or equal to 17 years at the time of signing informed consent/assent
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosis of type 2 diabetes mellitus at least 3 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metformin Maximum Tolerated Dose | Intolerance to Metformin
Item
treated with the maximum tolerated stable dose of metformin for at least 3 months prior to screening or have documented complete metformin intolerance
boolean
C0025598 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) above or equal to 7.0% and below or equal to 10.5% (above or equal to 53 mmol/mol and below or equal to 91 mmol/mol) at screening
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Maturity onset diabetes mellitus in young
Item
maturity onset diabetes of the young (mody)
boolean
C0342276 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting c-peptide at screening below 0.6 ng/ml
boolean
C2208720 (UMLS CUI [1])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function defined as alanine aminotransferase (alt) above or equal to 2.5 times upper normal limit
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Pharmacotherapy Indication Diabetes Mellitus | Pharmacotherapy Indication Obesity | Exception Pharmaceutical Preparations Inclusion criteria
Item
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 3 months before the day of screening
boolean
C0013216 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C3146298 (UMLS CUI [2,2])
C0028754 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1512693 (UMLS CUI [3,3])
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