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

December 9, 2014 updated by: Adocia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BioChaperone insulin lispro 0.2U/Kg
Drug: BioChaperone insulin lispro 0.2U/Kg
Single dose of 0.2U/Kg body weight injected subcutaneously
Drug: BioChaperone insulin lispro 0.1U/Kg
Single dose of 0.1U/Kg body weight injected subcutaneously
Drug: BioChaperone insulin lispro 0.4U/Kg
Single dose of 0.4U/Kg body weight injected subcutaneously
Drug: Humalog®
Single dose of 0.2U/Kg body weight injected subcutaneously
Experimental: BioChaperone insulin lispro 0.1U/Kg
Drug: BioChaperone insulin lispro 0.2U/Kg
Single dose of 0.2U/Kg body weight injected subcutaneously
Drug: BioChaperone insulin lispro 0.1U/Kg
Single dose of 0.1U/Kg body weight injected subcutaneously
Drug: BioChaperone insulin lispro 0.4U/Kg
Single dose of 0.4U/Kg body weight injected subcutaneously
Drug: Humalog®
Single dose of 0.2U/Kg body weight injected subcutaneously
Experimental: BioChaperone insulin lispro 0.4U/Kg
Drug: BioChaperone insulin lispro 0.2U/Kg
Single dose of 0.2U/Kg body weight injected subcutaneously
Drug: BioChaperone insulin lispro 0.1U/Kg
Single dose of 0.1U/Kg body weight injected subcutaneously
Drug: BioChaperone insulin lispro 0.4U/Kg
Single dose of 0.4U/Kg body weight injected subcutaneously
Drug: Humalog®
Single dose of 0.2U/Kg body weight injected subcutaneously
Active Comparator: Humalog® 0.2U/Kg
Drug: BioChaperone insulin lispro 0.2U/Kg
Single dose of 0.2U/Kg body weight injected subcutaneously
Drug: BioChaperone insulin lispro 0.1U/Kg
Single dose of 0.1U/Kg body weight injected subcutaneously
Drug: BioChaperone insulin lispro 0.4U/Kg
Single dose of 0.4U/Kg body weight injected subcutaneously
Drug: Humalog®
Single dose of 0.2U/Kg body weight injected subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucodynamic endpoint: Area Under the Curve GIR(0-last)
Time Frame: 12 hours
Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp
12 hours
Glucodynamic endpoint: GIRMax
Time Frame: 12 hours
Maximum Glucose Infusion Rate
12 hours
Pharmacokinetic endpoint: AUC Lisp(0-last)
Time Frame: 12 hours
Area under the insulin lispro serum concentration - time curve over the clamp procedure.
12 hours
Pharmacokinetic endpoint: Cmax(Lisp)
Time Frame: 12 hours
Maximum observed serum insulin lispro concentration
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics: Tmax(lisp)
Time Frame: 12 hours
Time to maximum observed serum insulin lispro concentration
12 hours
Glucodynamic: TGIRmax
Time Frame: 12 hours
Time to maximum Glucose Infusion Rate
12 hours
Tonset of action
Time Frame: 12 hours
Time from t=0 until blood glucose concentration has decreased by 5mg.dL (0.3mmol.L) from baseline.
12 hours
Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adocia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC3-CT008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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