ID

43524

Description

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

Keywords

  1. 5/29/16 5/29/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes NCT01526941

Eligibility Diabetes NCT01526941

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

Inclusion Criteria

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

type 1 diabetes

Data type

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
Description

soluble human insulin, lispro, nph insulin, lantus

Data type

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
Description

bmi

Data type

boolean

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

self blood glucose monitoring

Data type

boolean

Alias
UMLS CUI [1]
C0005803
Exclusion Criteria
Description

Exclusion Criteria

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

investigational drug

Data type

boolean

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

total daily insulin dose

Data type

boolean

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

insulin aspart

Data type

boolean

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

substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
impaired hepatic function
Description

impaired hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
impaired renal function
Description

renal function

Data type

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
Description

blood donation, hemoglobin

Data type

boolean

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

cardiac problems

Data type

boolean

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

hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020538

Similar models

Eligibility Diabetes NCT01526941

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01526941
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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