ID

29215

Beschrijving

Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00537303

Link

https://clinicaltrials.gov/show/NCT00537303

Trefwoorden

  1. 08-03-18 08-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 maart 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Diabetes NCT00537303

Eligibility Diabetes NCT00537303

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00537303
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus for more than 6 months
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c (glycosylated haemoglobin a1c) between 7.5 % and 10.0% at trial initiation (screening)
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
bmi (body mass index) less than 40 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
basal insulin treatment for at least 3 months (nph once or twice daily, insulin glargine or detemir once daily)
Beschrijving

Basal insulin | NPH insulin Frequency Daily | Insulin Glargine Frequency Daily | Insulin detemir Frequency Daily

Datatype

boolean

Alias
UMLS CUI [1]
C0650607
UMLS CUI [2,1]
C0021658
UMLS CUI [2,2]
C0439603
UMLS CUI [2,3]
C0332173
UMLS CUI [3,1]
C0907402
UMLS CUI [3,2]
C0439603
UMLS CUI [3,3]
C0332173
UMLS CUI [4,1]
C0537270
UMLS CUI [4,2]
C0439603
UMLS CUI [4,3]
C0332173
treatment with one to 3 oads
Beschrijving

Antidiabetics Oral Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to trial products or related products
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
previous participation in any trial including this for the last 6 months
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
use of more than 1 u/kg of basal insulin daily at trial initiation (screening)
Beschrijving

Basal insulin Dosage per day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439505

Similar models

Eligibility Diabetes NCT00537303

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00537303
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus for more than 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin a1c) between 7.5 % and 10.0% at trial initiation (screening)
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) less than 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Basal insulin | NPH insulin Frequency Daily | Insulin Glargine Frequency Daily | Insulin detemir Frequency Daily
Item
basal insulin treatment for at least 3 months (nph once or twice daily, insulin glargine or detemir once daily)
boolean
C0650607 (UMLS CUI [1])
C0021658 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0907402 (UMLS CUI [3,1])
C0439603 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
C0537270 (UMLS CUI [4,1])
C0439603 (UMLS CUI [4,2])
C0332173 (UMLS CUI [4,3])
Antidiabetics Oral Quantity
Item
treatment with one to 3 oads
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status
Item
previous participation in any trial including this for the last 6 months
boolean
C2348568 (UMLS CUI [1])
Basal insulin Dosage per day
Item
use of more than 1 u/kg of basal insulin daily at trial initiation (screening)
boolean
C0650607 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])

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