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

May 31, 2017 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

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

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 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.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BioChaperone insulin lispro
Drug: BioChaperone insulin lispro
Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)
Active Comparator: Humalog®
Drug: Humalog®
Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve (AUC)
Time Frame: 30 minutes
Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics: Early t0.5max(Lisp)
Time Frame: up to 6 hours post administration of study drug
Time to first observed half maximum observed insulin lispro concentration
up to 6 hours post administration of study drug
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours
Time Frame: 6 hours
6 hours
Glucodynamics: Early t0.5(GIRmax)
Time Frame: 6 hours
Time to first observed half maximum glucose infusion rate
6 hours
Glucodynamic: GIRmax (Maximum glucose infusion rate)
Time Frame: 6 hours
6 hours
Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours
Time Frame: 6 hours
6 hours
Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration
Time Frame: 6 hours
6 hours
Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Time Frame: 8 weeks
8 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

December 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC3-CT006

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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