A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes

May 31, 2017 updated by: Adocia

Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 in Subjects With Type 1 Diabetes

BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro.

The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg.

This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate dosing visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

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 (or equal to ) 12 months,
  • Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
  • Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive)

Exclusion Criteria:

  • Type 2 diabetes mellitus,
  • The receipt of any investigational product within 3 month 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 and any tobacco product within 5 years 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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Drug: BioChaperone® Combo
Drug: BioChaperone® Combo
Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
ACTIVE_COMPARATOR: B
Drug: Humalog® Mix25
Drug: Humalog® Mix25
Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)
Time Frame: from 0 to 30 hours after a single-dose administration
from 0 to 30 hours after a single-dose administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25
Time Frame: from 0 to 30 hours after a single-dose administration
from 0 to 30 hours after a single-dose administration
Number of Adverse Events
Time Frame: Weeks 0-10
hypoglycemic events, local tolerability, adverse reactions
Weeks 0-10

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

November 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (ESTIMATE)

November 11, 2013

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-CT005

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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