Diabetes Mellitus Type 1 Clinical Trial
Official title:
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the
duration of action of insulin lispro due to facilitation of the absorption of the insulin
after subcutaneous injection.
The aim of the trial is to investigate the dose-response and the dose-exposure relationships
of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and
glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and
to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.
This is a double-blinded, randomised, four-period crossover phase 2 trial using automated
12-hour euglycemic clamps in subject with type 1 diabetes mellitus.
Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of
three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose
of Humalog® (0.2 U/Kg) on 4 separate dosing visits.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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