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

NCT ID: NCT02029924

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-08-31

Brief Summary

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.

Conditions

Diabetes Mellitus Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BioChaperone insulin lispro

BioChaperone insulin lispro

Group Type: EXPERIMENTAL

BioChaperone insulin lispro

Intervention Type: DRUG

Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)

Humalog®

Humalog®

Group Type: ACTIVE_COMPARATOR

Humalog®

Intervention Type: DRUG

Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)

Interventions

BioChaperone insulin lispro

Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)

Intervention Type: DRUG

Humalog®

Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Adocia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Neuss, , Germany

Countries

Germany

Other Identifiers

BC3-CT006

Identifier Type: -

Identifier Source: org_study_id