ID

34287

Descripción

Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01486966

Link

https://clinicaltrials.gov/show/NCT01486966

Palabras clave

  1. 16/1/19 16/1/19 -
Titular de derechos de autor

see on clinicaltrials.gov

Subido en

16 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Diabetes NCT01486966

Eligibility Diabetes NCT01486966

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01486966
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer
Descripción

ID.1

Tipo de datos

boolean

currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without oad(s), and total daily insulin dose less than 1.4 iu (u)/kg (if treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months)
Descripción

ID.2

Tipo de datos

boolean

body mass index (bmi) equal to 40 kg/m^2 or below
Descripción

ID.3

Tipo de datos

boolean

hba1c (glycosylated haemoglobin a1c) between 7.0% and 10.0% by central laboratory analysis
Descripción

ID.4

Tipo de datos

boolean

plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation
Descripción

ID.5

Tipo de datos

boolean

Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with thiazolidinediones (tzd) or glucagon-like peptide-1 (glp-1) receptor agonists within the last 3 months prior to the screening
Descripción

ID.6

Tipo de datos

boolean

anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (mao) inhibitors
Descripción

ID.7

Tipo de datos

boolean

previous participation in this trial (participation is defined as randomised. re-screening of screening failures is allowed only once within the limits of the recruitment period.)
Descripción

ID.8

Tipo de datos

boolean

Similar models

Eligibility Diabetes NCT01486966

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01486966
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer
boolean
ID.2
Item
currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without oad(s), and total daily insulin dose less than 1.4 iu (u)/kg (if treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months)
boolean
ID.3
Item
body mass index (bmi) equal to 40 kg/m^2 or below
boolean
ID.4
Item
hba1c (glycosylated haemoglobin a1c) between 7.0% and 10.0% by central laboratory analysis
boolean
ID.5
Item
plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation
boolean
Item Group
C0680251 (UMLS CUI)
ID.6
Item
treatment with thiazolidinediones (tzd) or glucagon-like peptide-1 (glp-1) receptor agonists within the last 3 months prior to the screening
boolean
ID.7
Item
anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (mao) inhibitors
boolean
ID.8
Item
previous participation in this trial (participation is defined as randomised. re-screening of screening failures is allowed only once within the limits of the recruitment period.)
boolean

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