ID

42742

Beschrijving

Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01536028

Link

https://clinicaltrials.gov/show/NCT01536028

Trefwoorden

  1. 16-03-17 16-03-17 -
  2. 17-09-21 17-09-21 -
Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Diabetes NCT01536028

Eligibility Diabetes NCT01536028

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01536028
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Insulin-Dependent Diabetes Mellitus disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
serum c-peptide maximum 0.4 ng/ml
Beschrijving

C-peptide Maximum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006558
UMLS CUI [1,2]
C0806909
current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, nph insulin, insulin detemir or insulin glargine
Beschrijving

Therapeutic procedure Bolus Basis | Insulin soluble human | Insulin Lispro | Insulin, Glulisine | insulin, isophane | insulin detemir | Insulin Glargine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1705509
UMLS CUI [1,3]
C1527178
UMLS CUI [2]
C0795635
UMLS CUI [3]
C0293359
UMLS CUI [4]
C1313386
UMLS CUI [5]
C0021658
UMLS CUI [6]
C0537270
UMLS CUI [7]
C0907402
bmi (body mass index) maximum 32 kg/m^2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
hba1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
Beschrijving

Glycosylated hemoglobin A Percentage Maximum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0806909
non-smoker
Beschrijving

Non-smoker

Datatype

boolean

Alias
UMLS CUI [1]
C0337672
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Investigational New Drugs

Datatype

boolean

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

Insulin Cumulative Dose U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0456683
current treatment with iasp (insulin aspart) products
Beschrijving

Insulin Aspart

Datatype

boolean

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

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
impaired hepatic function
Beschrijving

Liver Dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
impaired renal function
Beschrijving

Renal Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
cardiac problems
Beschrijving

cardiac problem

Datatype

boolean

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

Uncontrolled hypertension Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082

Similar models

Eligibility Diabetes NCT01536028

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01536028
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus disease length
Item
type 1 diabetes for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C-peptide Maximum
Item
serum c-peptide maximum 0.4 ng/ml
boolean
C0006558 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Therapeutic procedure Bolus Basis | Insulin soluble human | Insulin Lispro | Insulin, Glulisine | insulin, isophane | insulin detemir | Insulin Glargine
Item
current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, nph insulin, insulin detemir or insulin glargine
boolean
C0087111 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C1527178 (UMLS CUI [1,3])
C0795635 (UMLS CUI [2])
C0293359 (UMLS CUI [3])
C1313386 (UMLS CUI [4])
C0021658 (UMLS CUI [5])
C0537270 (UMLS CUI [6])
C0907402 (UMLS CUI [7])
Body mass index
Item
bmi (body mass index) maximum 32 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage Maximum
Item
hba1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-smoker
Item
non-smoker
boolean
C0337672 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
the receipt of any investigational drug within the last 30 days prior to this trial
boolean
C0013230 (UMLS CUI [1])
Insulin Cumulative Dose U/day
Item
total daily insulin dose at least 1.8 u/kg/day
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Insulin Aspart
Item
current treatment with iasp (insulin aspart) products
boolean
C1708521 (UMLS CUI [1])
Substance Use Disorders
Item
a history of drug or alcohol abuse within the last 5 years
boolean
C0038586 (UMLS CUI [1])
Liver Dysfunction
Item
impaired hepatic function
boolean
C0086565 (UMLS CUI [1])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
cardiac problem
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
Uncontrolled hypertension Severe
Item
severe, uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])

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