Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal

May 31, 2017 updated by: Adocia

The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.

This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.

This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

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

  • Germany
      • Neuss, Germany, 41460
        • Profil 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

All

Description

Inclusion Criteria:

  • Type 1 Diabetes Mellitus ≥ 12 months
  • Treated with multiple daily insulin injections or CSII ≥ 12 months
  • BMI 18.5-28.0 kg/m² (both inclusive)
  • HbA1C%≤9%

Exclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Receipt of any trial product within 60 days prior to this trial
  • Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease
  • Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator
  • Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
  • Any systemic treatment with drugs known to interfere with glucose metabolism
  • Use of any tobacco or nicotine-contained product within one year 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Humalog®
Drug: Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously
Experimental: Biochaperone Insulin Lispro
Drug: BioChaperone insulin lispro
Single dose of 0.2 U/kg body weight injected subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the blood glucose time curve: AUCbg(0-2h)
Time Frame: 2 hours
Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)
Time Frame: 8 hours
8 hours
Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax
Time Frame: 8 hours
8 hours
Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)
Time Frame: 8 hours
8 hours
Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)
Time Frame: 8 hours
8 hours
Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Time Frame: Up to 7 weeks
Up to 7 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

January 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC3-CT011
  • 2014-005028-92 (EudraCT Number)

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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