Non-Insulin-Dependent Diabetes Mellitus Disease length Poorly controlled | Oral medication Quantity | Metformin | Sulfonylurea | Thiazolidinediones | Dipeptidyl Peptidase-4 Inhibitor | SGLT2 Inhibitor | GLP-1 Receptor Agonist | Use Associated with Insulin
Item
patients with t2dm, as defined by the american diabetes association/world health organization, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled after at least 1 year of treatment with 2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 [dpp-4] inhibitors, or sodium-glucose cotransporter 2 [sglt-2] inhibitors) or glucagon-like peptide-1 (glp-1) receptor agonists approved for use with insulin.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C3853134 (UMLS CUI [1,3])
C0175795 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
C3537225 (UMLS CUI [6])
C3273807 (UMLS CUI [7])
C2917359 (UMLS CUI [8])
C0457083 (UMLS CUI [9,1])
C0332281 (UMLS CUI [9,2])
C0021641 (UMLS CUI [9,3])
Adult | Informed Consent
Item
adult patients who have signed an informed consent form and health insurance portability and accountability act (hipaa) authorization form.
boolean
C0001675 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
hba1c <8.0% or >11.0%.
boolean
C0474680 (UMLS CUI [1])
Age
Item
males or females <18 years of age.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Abnormality Clinical Significance Physical Examination | Abnormality Clinical Significance Laboratory Procedures | Abnormality Clinical Significance Vital signs | Systemic disease Major | Life Expectancy Short | Study Subject Participation Status Limited
Item
any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the investigator would restrict or limit the patient's successful participation for the duration of the study.
boolean
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0150404 (UMLS CUI [3,3])
C0442893 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0023671 (UMLS CUI [5,1])
C1806781 (UMLS CUI [5,2])
C2348568 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
Product Containing Insulin | Lantus | Levemir | Humulin | Novolin | Humalog | NovoLog | Apidra | Afrezza | Exception Use Temporary
Item
use of any product containing insulin (lantus, levemir, humulin, novolin, humalog, novolog, apidra, or afrezza) since the time of diagnosis with t2dm other than temporary use during pregnancy or hospitalization.
boolean
C1514468 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C0876064 (UMLS CUI [2])
C1314782 (UMLS CUI [3])
C3538423 (UMLS CUI [4])
C0028467 (UMLS CUI [5])
C0528249 (UMLS CUI [6])
C0939412 (UMLS CUI [7])
C1654827 (UMLS CUI [8])
C3834216 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0457083 (UMLS CUI [10,2])
C0205374 (UMLS CUI [10,3])
Product Containing Insulin | Lantus | Levemir | Humulin | Novolin | Humalog | NovoLog | Apidra | Afrezza
Item
use of any product containing insulin (lantus, levemir, humulin, novolin, humalog, novolog, apidra, or afrezza) occurring within 3 months prior to the time of screening.
boolean
C1514468 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C0876064 (UMLS CUI [2])
C1314782 (UMLS CUI [3])
C3538423 (UMLS CUI [4])
C0028467 (UMLS CUI [5])
C0528249 (UMLS CUI [6])
C0939412 (UMLS CUI [7])
C1654827 (UMLS CUI [8])
C3834216 (UMLS CUI [9])
Oral hypoglycemics | Exception Inclusion criteria | Investigational New Drugs | Biological agents | Investigational Medical Device
Item
use of oral hypoglycemic agents other than those noted in the inclusion criteria, glp-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, or device) within 3 months prior to the time of screening.
boolean
C0359086 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3])
C0005515 (UMLS CUI [4])
C2346570 (UMLS CUI [5])
Medical contraindication Insulin regime
Item
all contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective national product labeling for these products.
boolean
C1301624 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
women of childbearing potential with no effective contraceptive method.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Study Subject Participation Status | Considerations Incomplete
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])
C0518609 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])