ID

34287

Description

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

Keywords

  1. 1/16/19 1/16/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes NCT01486966

Eligibility Diabetes NCT01486966

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

Inclusion Criteria

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

ID.1

Data type

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)
Description

ID.2

Data type

boolean

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

ID.3

Data type

boolean

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

ID.4

Data type

boolean

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

ID.5

Data type

boolean

Exclusion Criteria
Description

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
Description

ID.6

Data type

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
Description

ID.7

Data type

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.)
Description

ID.8

Data type

boolean

Similar models

Eligibility Diabetes NCT01486966

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01486966
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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