Diabetes Mellitus, Non-Insulin-Dependent | Therapeutic procedure Insulin Glargine Humalog | Therapeutic procedure NovoLog
Item
patients with t2dm diagnosed for at least 12 months and treated with insulin glargine and humalog or novolog®/novorapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit
boolean
C0011860 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
C0528249 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0939412 (UMLS CUI [3,2])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Age Adulthood
Item
at screening visit, age under legal age of adulthood
boolean
C0001779 (UMLS CUI [1,1])
C0700597 (UMLS CUI [1,2])
Glycosylated hemoglobin A
Item
hba1c <6.5% or >10.0% at screening
boolean
C0019018 (UMLS CUI [1])
Diabetes | Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes other than t2dm
boolean
C0011847 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy and lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Not used
Item
women of childbearing potential not protected by highly effective contraceptive method of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0445107 (UMLS CUI [1,3])
Insulin pump Use
Item
use of insulin pump in the 6 months before screening visit
boolean
C1140609 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Insulin | Insulin Glargine | Humalog | NovoLog | Insulin Lispro
Item
use of insulin other than insulin glargine and humalog or novolog/novorapid in the 6 months prior to screening visit. liprolog® is an eu approved insulin lispro and is allowed in those countries where it is marketed
boolean
C0021641 (UMLS CUI [1])
C0907402 (UMLS CUI [2])
C0528249 (UMLS CUI [3])
C0939412 (UMLS CUI [4])
C0293359 (UMLS CUI [5])
Humalog ante cibus Use | NovoLog ante cibus Use
Item
use of humalog or novolog/novorapid less than 3 times daily, before each meal
boolean
C0528249 (UMLS CUI [1,1])
C1550738 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0939412 (UMLS CUI [2,1])
C1550738 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
Peptides Injectable | GLP-1 Receptor Agonist | Peptides
Item
use of non-injectable peptides (eg, glp-1-receptor-agonists or other peptides) in the 6 months prior to screening visit
boolean
C0030956 (UMLS CUI [1,1])
C0086466 (UMLS CUI [1,2])
C2917359 (UMLS CUI [2])
C0030956 (UMLS CUI [3])
Body mass index
Item
body mass index (bmi) ≥40kg/m² at screening visit
boolean
C1305855 (UMLS CUI [1])
Hospitalization Diabetic Ketoacidosis
Item
hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
boolean
C0019993 (UMLS CUI [1,1])
C0011880 (UMLS CUI [1,2])
Proliferative diabetic retinopathy Unstable | Diabetic Retinopathy Progressive Rapid | Macular retinal edema Requirement Therapeutic procedure | Therapeutic Lasers | Operative Surgical Procedures | Injectables
Item
unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period
boolean
C0154830 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0011884 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0456962 (UMLS CUI [2,3])
C0271051 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0181567 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0086466 (UMLS CUI [6])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
boolean
C2348568 (UMLS CUI [1])