ID

38879

Descrição

Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea; ODM derived from: https://clinicaltrials.gov/show/NCT01355718

Link

https://clinicaltrials.gov/show/NCT01355718

Palavras-chave

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

See clinicaltrials.gov

Transferido a

11 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT01355718

Inglês

Eligibility Diabetes NCT01355718

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01355718
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any study-related activities. (study-related activities are any procedure related to recording of data according to the protocol.)
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patients with type 2 diabetes mellitus
Descrição

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
patients who are currently treated with novonorm® alone or in combination with metformin or tzd
Descrição

NovoNorm | Combined Modality Therapy | Metformin | Thiazolidinediones

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0732644
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0025598
UMLS CUI [4]
C1257987
age: at least 18 years old
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients who will be prescribed with insulin analogue in addition to current novonorm® (with/without metformin/tzd) treatment at the discretion by the physician
Descrição

Insulin Analog In addition to NovoNorm | Metformin | Metformin Absent | Thiazolidinediones | Thiazolidinediones Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2825028
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0732644
UMLS CUI [2]
C0025598
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C1257987
UMLS CUI [5,1]
C1257987
UMLS CUI [5,2]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to study product(s) or related products
Descrição

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

Tipo de dados

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 study. participation is defined as screened
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
patients who have been treated with insulin preparations (including insulin analogues) previously
Descrição

Prior Therapy Insulin preparations | Prior Therapy Insulin Analog

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0021641
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C2825028
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
Descrição

Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
patients who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
Descrição

Protocol Compliance Unlikely | Uncooperative attitude | Clinic Visit Final Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
UMLS CUI [2]
C2188045
UMLS CUI [3,1]
C0008952
UMLS CUI [3,2]
C3853528
UMLS CUI [3,3]
C1299582
any other disease or condition that the physician feels would interfere with study participation or evaluation of results
Descrição

Disease Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Disease Interferes with Evaluation Research results | Condition Interferes with Evaluation Research results

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1261322
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C0683954
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Similar models

Eligibility Diabetes NCT01355718

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01355718
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any study-related activities. (study-related activities are any procedure related to recording of data according to the protocol.)
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
NovoNorm | Combined Modality Therapy | Metformin | Thiazolidinediones
Item
patients who are currently treated with novonorm® alone or in combination with metformin or tzd
boolean
C0732644 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
Age
Item
age: at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Insulin Analog In addition to NovoNorm | Metformin | Metformin Absent | Thiazolidinediones | Thiazolidinediones Absent
Item
patients who will be prescribed with insulin analogue in addition to current novonorm® (with/without metformin/tzd) treatment at the discretion by the physician
boolean
C2825028 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0732644 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1257987 (UMLS CUI [4])
C1257987 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
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 allergy to study 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 study. participation is defined as screened
boolean
C2348568 (UMLS CUI [1])
Prior Therapy Insulin preparations | Prior Therapy Insulin Analog
Item
patients who have been treated with insulin preparations (including insulin analogues) previously
boolean
C1514463 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C2825028 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Protocol Compliance Unlikely | Uncooperative attitude | Clinic Visit Final Unable
Item
patients who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C2188045 (UMLS CUI [2])
C0008952 (UMLS CUI [3,1])
C3853528 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Disease Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Disease Interferes with Evaluation Research results | Condition Interferes with Evaluation Research results
Item
any other disease or condition that the physician feels would interfere with study participation or evaluation of results
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
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