MedDataX Logo

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

NCT ID: NCT02146651

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BioChaperone insulin lispro 0.2U/Kg

BioChaperone insulin lispro 0.2U/Kg

Group Type EXPERIMENTAL

BioChaperone insulin lispro 0.2U/Kg

Intervention Type DRUG

Single dose of 0.2U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.1U/Kg

Intervention Type DRUG

Single dose of 0.1U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.4U/Kg

Intervention Type DRUG

Single dose of 0.4U/Kg body weight injected subcutaneously

Humalog®

Intervention Type DRUG

Single dose of 0.2U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.1U/Kg

BioChaperone insulin lispro 0.1U/Kg

Group Type EXPERIMENTAL

BioChaperone insulin lispro 0.2U/Kg

Intervention Type DRUG

Single dose of 0.2U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.1U/Kg

Intervention Type DRUG

Single dose of 0.1U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.4U/Kg

Intervention Type DRUG

Single dose of 0.4U/Kg body weight injected subcutaneously

Humalog®

Intervention Type DRUG

Single dose of 0.2U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.4U/Kg

BioChaperone insulin lispro 0.4U/Kg

Group Type EXPERIMENTAL

BioChaperone insulin lispro 0.2U/Kg

Intervention Type DRUG

Single dose of 0.2U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.1U/Kg

Intervention Type DRUG

Single dose of 0.1U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.4U/Kg

Intervention Type DRUG

Single dose of 0.4U/Kg body weight injected subcutaneously

Humalog®

Intervention Type DRUG

Single dose of 0.2U/Kg body weight injected subcutaneously

Humalog® 0.2U/Kg

Humalog® 0.2U/Kg

Group Type ACTIVE_COMPARATOR

BioChaperone insulin lispro 0.2U/Kg

Intervention Type DRUG

Single dose of 0.2U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.1U/Kg

Intervention Type DRUG

Single dose of 0.1U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.4U/Kg

Intervention Type DRUG

Single dose of 0.4U/Kg body weight injected subcutaneously

Humalog®

Intervention Type DRUG

Single dose of 0.2U/Kg body weight injected subcutaneously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BioChaperone insulin lispro 0.2U/Kg

Single dose of 0.2U/Kg body weight injected subcutaneously

Intervention Type DRUG

BioChaperone insulin lispro 0.1U/Kg

Single dose of 0.1U/Kg body weight injected subcutaneously

Intervention Type DRUG

BioChaperone insulin lispro 0.4U/Kg

Single dose of 0.4U/Kg body weight injected subcutaneously

Intervention Type DRUG

Humalog®

Single dose of 0.2U/Kg body weight injected subcutaneously

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Adocia

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Grit Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselfforschung GmbH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Profil Institut für stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BC3-CT008

Identifier Type: -

Identifier Source: org_study_id