A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers

December 17, 2015 updated by: Adocia

A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female

This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.

Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

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 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

All

Description

Inclusion Criteria:

  • Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
  • Age ≥ 18 and ≤ 64 years, both inclusive.
  • Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.
  • Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).
  • Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Receipt of any investigational medicinal product within 3 months before randomisation in this trial.

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: BioChaperone Lispro U-100
injection of 2 doses of 0.2 U/kg on separate visits
Drug: BioChaperone Lispro U-100
Injection of BioChaperone Lispro U-100
Experimental: BioChaperone Lispro U-200
injection of 2 doses of 0.2 U/kg on separate visits
Drug: BioChaperone Lispro U-200
Injection of BioChaperone Lispro U-200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCLisp (0-inf)
Time Frame: 8 hours
Area under the insulin lispro serum concentration - time curve from t=0 to infinity
8 hours
Cmax Lisp
Time Frame: 8 hours
Maximum observed insulin lispro serum concentration
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tmax Lisp
Time Frame: 8 hours
Time to maximum observed serum insulin lispro concentration
8 hours
AUCGIR(0-8h)
Time Frame: 8 hours
Area under the glucose infusion rate-time curve from t=0 to 8 hours
8 hours
GIRmax
Time Frame: 8 hours
Maximum glucose infusion rate
8 hours
tGIRmax
Time Frame: 8 hours
Time to maximum glucose infusion rate
8 hours
Number of Adverse events
Time Frame: Up to 9 weeks
Number of adverse events
Up to 9 weeks
Local tolerability
Time Frame: Up to 9 weeks
Record of injection site reaction
Up to 9 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

August 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 20, 2015

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC3-CT012

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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