Informed Consent
Item
informed consent obtained before any study-related activities. (study-related activities are any procedure related to recording of data according to the protocol.)
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
NovoNorm | Combined Modality Therapy | Metformin | Thiazolidinediones
Item
patients who are currently treated with novonorm® alone or in combination with metformin or tzd
boolean
C0732644 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
Age
Item
age: at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Insulin Analog In addition to NovoNorm | Metformin | Metformin Absent | Thiazolidinediones | Thiazolidinediones Absent
Item
patients who will be prescribed with insulin analogue in addition to current novonorm® (with/without metformin/tzd) treatment at the discretion by the physician
boolean
C2825028 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0732644 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1257987 (UMLS CUI [4])
C1257987 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to study product(s) 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])
Study Subject Participation Status
Item
previous participation in this study. participation is defined as screened
boolean
C2348568 (UMLS CUI [1])
Prior Therapy Insulin preparations | Prior Therapy Insulin Analog
Item
patients who have been treated with insulin preparations (including insulin analogues) previously
boolean
C1514463 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C2825028 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Protocol Compliance Unlikely | Uncooperative attitude | Clinic Visit Final Unable
Item
patients who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C2188045 (UMLS CUI [2])
C0008952 (UMLS CUI [3,1])
C3853528 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Disease Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Disease Interferes with Evaluation Research results | Condition Interferes with Evaluation Research results
Item
any other disease or condition that the physician feels would interfere with study participation or evaluation of results
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])