ID

43524

Descripción

Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01526941

Link

https://clinicaltrials.gov/show/NCT01526941

Palabras clave

  1. 29/5/16 29/5/16 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Diabetes NCT01526941

Eligibility Diabetes NCT01526941

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01526941
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes for at least 12 months
Descripción

type 1 diabetes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
currently on basal bolus treatment with soluble human insulin, lispro and nph insulin or lantus. nph insulin may be administered once or twice daily
Descripción

soluble human insulin, lispro, nph insulin, lantus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0795635
UMLS CUI [2]
C0293359
UMLS CUI [3]
C0021658
UMLS CUI [4]
C0907402
bmi (body mass index) maximum 35 kg/m^2
Descripción

bmi

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
able and willing to perform self-blood glucose monitoring
Descripción

self blood glucose monitoring

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005803
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
the receipt of any investigational drug within the last 30 days prior to this trial
Descripción

investigational drug

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
total daily insulin dose at least 1.8 u/kg/day
Descripción

total daily insulin dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0557978
currently being treated with insulin aspart products
Descripción

insulin aspart

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708521
a history of drug abuse or alcohol dependence within the last 5 years
Descripción

substance abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
impaired hepatic function
Descripción

impaired hepatic function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
impaired renal function
Descripción

renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
Descripción

blood donation, hemoglobin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C0019046
cardiac problems
Descripción

cardiac problems

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262402
severe, uncontrolled hypertension
Descripción

hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538

Similar models

Eligibility Diabetes NCT01526941

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01526941
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
type 1 diabetes
Item
type 1 diabetes for at least 12 months
boolean
C0011854 (UMLS CUI [1])
soluble human insulin, lispro, nph insulin, lantus
Item
currently on basal bolus treatment with soluble human insulin, lispro and nph insulin or lantus. nph insulin may be administered once or twice daily
boolean
C0795635 (UMLS CUI [1])
C0293359 (UMLS CUI [2])
C0021658 (UMLS CUI [3])
C0907402 (UMLS CUI [4])
bmi
Item
bmi (body mass index) maximum 35 kg/m^2
boolean
C1305855 (UMLS CUI [1])
self blood glucose monitoring
Item
able and willing to perform self-blood glucose monitoring
boolean
C0005803 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
investigational drug
Item
the receipt of any investigational drug within the last 30 days prior to this trial
boolean
C0013230 (UMLS CUI [1])
total daily insulin dose
Item
total daily insulin dose at least 1.8 u/kg/day
boolean
C2348070 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
insulin aspart
Item
currently being treated with insulin aspart products
boolean
C1708521 (UMLS CUI [1])
substance abuse
Item
a history of drug abuse or alcohol dependence within the last 5 years
boolean
C0038586 (UMLS CUI [1])
impaired hepatic function
Item
impaired hepatic function
boolean
C0232741 (UMLS CUI [1])
renal function
Item
impaired renal function
boolean
C0232804 (UMLS CUI [1])
blood donation, hemoglobin
Item
blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
boolean
C0005794 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
cardiac problems
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
hypertension
Item
severe, uncontrolled hypertension
boolean
C0020538 (UMLS CUI [1])

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