A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

Adocia

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus Type 1

Treatments

Drug: BioChaperone insulin lispro

Drug: Humalog®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02029924

BC3-CT006

Details and patient eligibility

About

The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection.

The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg.

This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.

Enrollment

37 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 diabetes mellitus for at least 12 months.
Treated with multiple daily insulin injections or insulin pump for at least 12 months.
Body Mass Index (BMI): 18.0-28.0 Kg/m².

Exclusion criteria

Type 2 diabetes mellitus.
Receipt of any investigational product within 3 months prior to first dosing.
Clinically significant abnormalities as judged by the investigator.
Any systemic treatment with drugs known to interfere with glucose metabolism.
History of alcoholism, or drug/chemical abuse as per Investigator's judgement.
Use of tobacco or nicotine-contained product within 5 years prior to screening.
Blood or plasma donation in the past month or more than 500 mL within 3 months prior to screening.