Age
Item
males or females ≥18 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Insulin regime | Insulin During meal
Item
type 2 diabetes mellitus (t2dm) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months
boolean
C0011860 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
C0021641 (UMLS CUI [3,1])
C0587120 (UMLS CUI [3,2])
Body mass index
Item
body mass index (bmi) of 23.0 to 45.0 kilograms per meter squared (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated hemoglobin (hba1c) level 7.0 to 8.5%, inclusive
boolean
C0474680 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting c-peptide <0.6 nanograms per milliliter (ng/ml)
boolean
C2208720 (UMLS CUI [1])
Insulin Glargine times per day | Basal insulin
Item
willingness to use insulin glargine twice a day as basal insulin for the duration of the study
boolean
C0907402 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0650607 (UMLS CUI [2])
Avoidance Insulin pump | Avoidance Continuous glucose monitoring
Item
willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (cgm) during the study
boolean
C0870186 (UMLS CUI [1,1])
C1140609 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C4523945 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drug Component | Hypersensitivity Suspected Investigational New Drug Component
Item
known or suspected allergy to any component of any of the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C1705248 (UMLS CUI [2,4])
Use of Premixed insulin Exclusive
Item
exclusive use of pre-mixed insulins
boolean
C1524063 (UMLS CUI [1,1])
C2069057 (UMLS CUI [1,2])
C1548966 (UMLS CUI [1,3])
Pramlintide | exenatide | liraglutide
Item
use of pramlintide, exenatide, and/or liraglutide within 30 days of screening
boolean
C0537551 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
Sulfonylureas
Item
use of sulfonylureas within two months of screening
boolean
C0038766 (UMLS CUI [1])
Pharmaceutical Preparation Interferes with Interpretation Research results | Adrenal Cortex Hormones | Antimetabolites | Pharmaceutical Preparation Interferes with Insulin use | Pharmaceutical Preparation Interferes with Glucose utilization | Pharmaceutical Preparation Interferes with Recovery Hypoglycemia
Item
use of drugs (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, during the study or within 30 days of screening
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0001617 (UMLS CUI [2])
C0003376 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0240016 (UMLS CUI [4,3])
C0013227 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0017725 (UMLS CUI [5,3])
C0042153 (UMLS CUI [5,4])
C0013227 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2004454 (UMLS CUI [6,3])
C0020615 (UMLS CUI [6,4])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])