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

Adocia

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 1

Treatments: Drug: Humalog®; Drug: BioChaperone insulin lispro 0.2U/Kg; Drug: BioChaperone insulin lispro 0.4U/Kg; Drug: BioChaperone insulin lispro 0.1U/Kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02146651

BC3-CT008

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 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.

Enrollment: 38 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 of insulin pump for at least 12 months
• Body Mass Index (BMI): 18.5-28.0 Kg.m²

Exclusion criteria

• Type 2 diabetes mellitus
• Receipt of any investigational product within 3 months prior 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 1 year prior to screening
• Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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38 participants in 4 patient groups

BioChaperone insulin lispro 0.2U/Kg

Experimental group

Description:

BioChaperone insulin lispro 0.2U/Kg

Treatment:

Drug: BioChaperone insulin lispro 0.2U/Kg

Drug: BioChaperone insulin lispro 0.4U/Kg

Drug: Humalog®

Drug: BioChaperone insulin lispro 0.1U/Kg

BioChaperone insulin lispro 0.1U/Kg

Experimental group

Description:

BioChaperone insulin lispro 0.1U/Kg

Treatment:

Drug: BioChaperone insulin lispro 0.2U/Kg

Drug: BioChaperone insulin lispro 0.4U/Kg

Drug: Humalog®

Drug: BioChaperone insulin lispro 0.1U/Kg

BioChaperone insulin lispro 0.4U/Kg

Experimental group

Description:

BioChaperone insulin lispro 0.4U/Kg

Treatment:

Drug: BioChaperone insulin lispro 0.2U/Kg

Drug: BioChaperone insulin lispro 0.4U/Kg

Drug: Humalog®

Drug: BioChaperone insulin lispro 0.1U/Kg

Humalog® 0.2U/Kg

Active Comparator group

Description:

Humalog® 0.2U/Kg

Treatment:

Drug: BioChaperone insulin lispro 0.2U/Kg

Drug: BioChaperone insulin lispro 0.4U/Kg

Drug: Humalog®

Drug: BioChaperone insulin lispro 0.1U/Kg