ID

29227

Description

Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00700830

Link

https://clinicaltrials.gov/show/NCT00700830

Keywords

  1. 3/10/18 3/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 10, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes NCT00700830

Eligibility Diabetes NCT00700830

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00700830
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c between 7-9%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
insulin naive
Description

Insulin naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
inadequate control with oral antidiabetics therapy as judged by investigator
Description

Control Inadequate | Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0243148
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
hypersensitivity to levemir® or to any of the excipients
Description

Hypersensitivity Levemir | Hypersensitivity Levemir Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1314782
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1314782
UMLS CUI [2,3]
C0015237
pregnancy, or desire of pregnancy within next 6 months
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
hba1c greater than or equal to 9%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
known or suspected allergy to the trial product or to any of the excipients
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient | Hypersensitivity Suspected Investigational New Drugs Excipient

Data type

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]
C0013230
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013230
UMLS CUI [4,4]
C0015237
subjects who are unlikely to comply with protocol
Description

Protocol Compliance Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558

Similar models

Eligibility Diabetes NCT00700830

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00700830
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c between 7-9%
boolean
C0202054 (UMLS CUI [1])
Insulin naive
Item
insulin naive
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Control Inadequate | Antidiabetics Oral
Item
inadequate control with oral antidiabetics therapy as judged by investigator
boolean
C0243148 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
patients with type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Hypersensitivity Levemir | Hypersensitivity Levemir Excipient
Item
hypersensitivity to levemir® or to any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C1314782 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1314782 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Pregnancy | Pregnancy, Planned
Item
pregnancy, or desire of pregnancy within next 6 months
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Glucohemoglobin measurement
Item
hba1c greater than or equal to 9%
boolean
C0202054 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient | Hypersensitivity Suspected Investigational New Drugs Excipient
Item
known or suspected allergy to the trial product or to any of the excipients
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])
C0013230 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
C0015237 (UMLS CUI [4,4])
Protocol Compliance Unlikely
Item
subjects who are unlikely to comply with protocol
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])

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