Type 1 Diabetes Mellitus Clinical Trial
Official title:
A Single-Center, Randomized, Double-Blind, 3-Treatment, 3-Period, 6-Sequence Cross-Over Study To Compare The Pharmacokinetic And Pharmacodynamic Effects of Single Doses of Insulin Glargine Given As U200 And U500 To Lantus® In A Euglycemic Clamp Setting In Subjects With Type 1 Diabetes
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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