Primary Objective: To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes. Secondary Objectives: To compare the metabolic activity characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes. To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in subjects with type 1 diabetes.
Total study duration for each subject is between 3.5 and 12 weeks. Two overnight stays at the unit in each of 3 treatment periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
36
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Investigational Site Number 276001
Neuss, Germany
Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing
Time frame: 12 hours
INS-Area Under the Curve (AUC) over 24 and 36 hours after dosing (INS AUC 0-24 and INS AUC 0-36)
Time frame: 36 hours
AUC up to the last measurable concentration
Time frame: 36 hours
Time to reach 50% of INS-AUC 0-36
Time frame: 36 hours
Time to reach INS-Cmax (INS-tmax)
Time frame: 36 hours
Area under the body-weight-standardized Glucose Infusion Rate (GIR) over the first 12, 24 and 36 hours after dosing (GIR-AUC0-12, GIR-AUC0-24 and, GIR-AUC0-36)
Time frame: 36 hours
Time to reach 50% of GIR-AUC0-36 (T50%-GIR-AUC0-36)
Time frame: 36 hours
Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and time to GIRmax (GIR-Tmax)
Time frame: 36 hours
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above different pre-specific blood glucose levels)
Time frame: 4 days
Safety and tolerability (Number of patients with adverse events, clinically significant changes in vital signs, laboratory parameters)
Time frame: 4 days
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