Diabetes
Conditions
Keywords
Insulin
Brief summary
The purpose of this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels.
Interventions
Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)
DRUGComparator: insulin glargine
Insulin glargine at 0.4 U/kg
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Part 1: * Patient is a male between 18 to 45 years of age (inclusive) at the prestudy (screening) visit * Patient has a clinical diagnosis of type 1 diabetes * Patient must have been treated with insulin since diagnosis and be on a stable dose of insulin * Patient has a Body Mass Index (BMI) of \<=27 kg/m2 and \>18 kg/m2 * Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months Part 2: * Subject is a male between 18 to 45 years of age at the prestudy (screening) visit * Subject has a Body Mass Index (BMI) of \<=25 kg/m\^2 * Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
Exclusion criteria
Part 1: * Patient has a history of stroke, chronic seizures, or major neurological disorder * Patient has currently active and untreated clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases * Patient has a history of hypertension requiring treatment * Patient has a history of neoplastic disease within the past 5 years * Patient is currently being treated with, or has a history of treatment with any oral antihyperglycemic agent * Patient has a history of significant multiple and/or severe allergies Part 2: * Subject has a history of stroke, chronic seizures, or major neurological disorder * Subject has a history of hypertension requiring treatment * Subject has a history of neoplastic disease within the past 5 years * Subject has history of diabetes (Type 1, Type 2 or steroid-induced) or family history of diabetes mellitus * Subject has a history of hypersensitivity to glargine or any of its inactive ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action) | Baseline and 30 hours |
| Part II: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR (AUC of glucose infusion rate), GIRmax (maximum level of glucose infusion rate), over the duration of action of glargine | Baseline and 30 hours |
Secondary
| Measure | Time frame |
|---|---|
| Part I: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR and GIRmax over the duration of action of glargine | Baseline and 30 hours |
| Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action) | Baseline and 30 hours |
Outcome results
None listed