ID

38879

Beschrijving

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

Trefwoorden

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

See clinicaltrials.gov

Geüploaded op

11 november 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes NCT01355718

Engels

Eligibility Diabetes NCT01355718

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01355718
Inclusion Criteria
Beschrijving

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.)
Beschrijving

Informed Consent

Datatype

boolean

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

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

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

NovoNorm | Combined Modality Therapy | Metformin | Thiazolidinediones

Datatype

boolean

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

Age

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Exclusion Criteria

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

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

Datatype

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
Beschrijving

Study Subject Participation Status

Datatype

boolean

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

Prior Therapy Insulin preparations | Prior Therapy Insulin Analog

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Protocol Compliance Unlikely | Uncooperative attitude | Clinic Visit Final Unable

Datatype

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
Beschrijving

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

Datatype

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
Terug naar het begin van de pagina

Similar models

Eligibility Diabetes NCT01355718

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01355718
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial