ID

12775

Description

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

Link

https://clinicaltrials.gov/show/NCT00789711

Keywords

  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes NCT00789711

Eligibility Diabetes NCT00789711

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

Inclusion Criteria

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

diabetes mellitus

Data type

boolean

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

Antidiabetics Oral

Data type

boolean

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

human insulin

Data type

boolean

Alias
UMLS CUI [1]
C0020171
Exclusion Criteria
Description

Exclusion Criteria

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

compliance

Data type

boolean

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

Study Subject Participation Status

Data type

boolean

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

therapy novomix

Data type

boolean

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

hypersensitivity novomix

Data type

boolean

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

hypersensitivity levemir

Data type

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
Description

pregnant; contraceptive methods

Data type

boolean

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

contraindication

Data type

boolean

Alias
UMLS CUI [1]
C1301624

Similar models

Eligibility Diabetes NCT00789711

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00789711
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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