ID

12775

Beskrivning

An Observational Study to Compare the Safety and Effectiveness of NovoMix® 30 and Levemir™ for the Treatment of Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00789711

Länk

https://clinicaltrials.gov/show/NCT00789711

Nyckelord

  1. 2015-12-21 2015-12-21 -
Uppladdad den

21 december 2015

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Diabetes NCT00789711

Eligibility Diabetes NCT00789711

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00789711
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with type 1 or type 2 diabetes mellitus
Beskrivning

diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
patients uncontrolled on oral antidiabetic drugs
Beskrivning

Antidiabetics Oral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0442027
insulin naïve patients or patients currently on human insulin
Beskrivning

human insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0020171
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who are unlikely to comply with protocol requirements
Beskrivning

compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
subjects who are previously enrolled in novomix® 30 and levemir™ study
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
subjects on novomix® 30 and levemir™ therapy
Beskrivning

therapy novomix

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1170447
subjects with hypersensitivity to novomix® 30 or to any of the excipients
Beskrivning

hypersensitivity novomix

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1170447
subjects with hypersensitivity to levemir™ or to any of the excipients
Beskrivning

hypersensitivity levemir

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1314782
females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice
Beskrivning

pregnant; contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0700589
contraindications and warnings specified in the current prescribing information
Beskrivning

contraindication

Datatyp

boolean

Alias
UMLS CUI [1]
C1301624

Similar models

Eligibility Diabetes NCT00789711

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00789711
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
diabetes mellitus
Item
patients diagnosed with type 1 or type 2 diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Antidiabetics Oral
Item
patients uncontrolled on oral antidiabetic drugs
boolean
C0935929 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
human insulin
Item
insulin naïve patients or patients currently on human insulin
boolean
C0020171 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
compliance
Item
subjects who are unlikely to comply with protocol requirements
boolean
C1321605 (UMLS CUI [1])
Study Subject Participation Status
Item
subjects who are previously enrolled in novomix® 30 and levemir™ study
boolean
C2348568 (UMLS CUI [1])
therapy novomix
Item
subjects on novomix® 30 and levemir™ therapy
boolean
C0087111 (UMLS CUI [1,1])
C1170447 (UMLS CUI [1,2])
hypersensitivity novomix
Item
subjects with hypersensitivity to novomix® 30 or to any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C1170447 (UMLS CUI [1,2])
hypersensitivity levemir
Item
subjects with hypersensitivity to levemir™ or to any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C1314782 (UMLS CUI [1,2])
pregnant; contraceptive methods
Item
females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice
boolean
C0549206 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
contraindication
Item
contraindications and warnings specified in the current prescribing information
boolean
C1301624 (UMLS CUI [1])

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