Study Subject All
Item
all participants
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Gender Healthy | Diabetes Mellitus, Insulin-Dependent
Item
are healthy males or participants with t1dm
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0011854 (UMLS CUI [2])
Body mass index
Item
have a screening body mass index (bmi) of 20.0-29.9 kilograms per square meter (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Healthy Volunteers
Item
healthy participants only
boolean
C1708335 (UMLS CUI [1])
Healthy Volunteers Medical History | Healthy Volunteers Physical Examination
Item
are overtly healthy, as determined by medical history and physical examination
boolean
C1708335 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Fasting blood glucose measurement
Item
have a fasting blood glucose <108 milligrams/deciliter (mg/dl) (6.0 millimoles/liter [mmol/l]) at screening
boolean
C0428568 (UMLS CUI [1])
Study Subject Insulin-Dependent Diabetes Mellitus
Item
participants with t1dm only
boolean
C0681850 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Insulin-Dependent Diabetes Mellitus Disease length
Item
have a diagnosis of t1dm for at least 1 year based on medical history
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C-peptide measurement
Item
have a screening c-peptide <0.5 nanogram/milliliter (ng/ml)
boolean
C0202100 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
have a hemoglobin a1c (hba1c) of 6.0 to 9.0% at screening
boolean
C0474680 (UMLS CUI [1])
Absence Episode of Hypoglycemia Severe | Absence Neurologic Symptoms Consistent with Neuroglycopenia
Item
have had no episodes of severe hypoglycemia in the past 6 months (severe hypoglycemia is defined as having neurological symptoms consistent with neuroglycopenia and having required assistance in treatment by a second party)
boolean
C0332197 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0235031 (UMLS CUI [2,2])
C0332290 (UMLS CUI [2,3])
C0342311 (UMLS CUI [2,4])
Study Subject All
Item
all participants
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Hemoglobin measurement
Item
have a hemoglobin level <12.0 grams/deciliter (g/dl) at screening
boolean
C0518015 (UMLS CUI [1])
Tobacco use Regular
Item
is currently a smoker or used tobacco products on a regular basis in the 6 months prior to screening, or intending to smoke during the study
boolean
C0543414 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Healthy Volunteers
Item
healthy participants only
boolean
C1708335 (UMLS CUI [1])
Non-Prescription Drugs Regular | Prescription Drugs Regular | Exception Vitamin and Mineral Supplement | Exception Acetaminophen Infrequent | Exception Ibuprofen Infrequent
Item
• regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen). if this situation arises, inclusion of an otherwise suitable participants may be at the discretion of the investigator
boolean
C0013231 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0304227 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0724359 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0000970 (UMLS CUI [4,2])
C0521114 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0020740 (UMLS CUI [5,2])
C0521114 (UMLS CUI [5,3])
Study Subject Insulin-Dependent Diabetes Mellitus
Item
participants with t1dm only
boolean
C0681850 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Non-Prescription Drugs Regular | Prescription Drugs Regular | Dietary Supplements Regular | Pharmaceutical Preparations Affecting Blood Glucose | Pharmaceutical Preparations Affecting Insulin Sensitivity | Pharmaceutical Preparations Promoting Weight loss
Item
regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
boolean
C0013231 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0304227 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0242295 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0005802 (UMLS CUI [4,3])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0920563 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C0033414 (UMLS CUI [6,2])
C1262477 (UMLS CUI [6,3])
Systemic Glucocorticoids chronic | Glucocorticoid therapy by Inhalation chronic | Exception Preparations Topical | Exception Preparations Intraarticular | Exception Preparations Intraocular
Item
are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0744425 (UMLS CUI [2,1])
C0205535 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1522168 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C1522204 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C1522223 (UMLS CUI [5,3])
Insulin Cumulative Dose U/day
Item
require a total daily insulin dose exceeding 100 units (u)
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Serum fasting triglyceride measurement
Item
have fasting triglycerides >400 mg/dl
boolean
C0582824 (UMLS CUI [1])