ID

38993

Descrição

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

Palavras-chave

Versões (1)
  1. 18/11/2019 18/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

18 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT02131272

Inglês

Eligibility Diabetes NCT02131272

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02131272
Inclusion Criteria
Descrição

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
Descrição

Informed Consent | Informed Consent Patient Representative | Child Assent

Tipo de dados

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
Descrição

Age

Tipo de dados

boolean

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

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
Descrição

Metformin Maximum Tolerated Dose | Intolerance to Metformin

Tipo de dados

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
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Descrição

Exclusion Criteria

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

Maturity onset diabetes mellitus in young

Tipo de dados

boolean

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

Fasting C-peptide level

Tipo de dados

boolean

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

Liver Dysfunction | Alanine aminotransferase increased

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

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

Tipo de dados

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 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02131272
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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