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])
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])