A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump

December 11, 2017 updated by: Adocia

A Euglycaemic Clamp Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of a Bolus Dose of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® by an Insulin Pump

This is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. In a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 U/kg body weight.

Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.

Study Overview

Study Type

Interventional

Enrollment (Actual)

43

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

      • 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:

  • Type 1 Diabetes Mellitus for more than 12 months.
  • BMI between 18.5 and 28.5 kg/m².
  • HbA1C level <=9.0%.
  • Insulin treated for at least 12 months with total insulin dose <1.2U/kg/day.

Exclusion Criteria:

  • Type 2 Diabetes Mellitus.
  • History of multiple and/or severe allergies to drugs or foods.
  • Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.
  • More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
  • Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
  • Females of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BioChaperone® insulin lispro
Single subcutaneous administration of BioChaperone® insulin lispro
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Active Comparator: Fiasp®
Single subcutaneous administration of Fiasp® (insulin aspart)
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Active Comparator: Novorapid®
Single subcutaneous administration of Novorapid® (insulin aspart)
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCGIR(0-60min)
Time Frame: 60 minutes
Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCins(0-30min)
Time Frame: 30 minutes
Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration
30 minutes
AUCins(0-60min)
Time Frame: 60 minutes
Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration
60 minutes
AUCins(0-600min)
Time Frame: 600 minutes
Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration
600 minutes
Cmax insulin
Time Frame: 10 hours
Maximum observed baseline corrected insulin concentration
10 hours
Tmax insulin
Time Frame: 10 hours
Time from bolus administration to baseline corrected Cmax
10 hours
TmaxGIR
Time Frame: 10 hours
Time from bolus administration to maximum baseline corrected glucose infusion rate
10 hours
GIRmax
Time Frame: 10 hours
Maximum baseline corrected glucose infusion rate
10 hours
Adverse Events
Time Frame: up to 8 weeks
Number of Adverse Events in each arm
up to 8 weeks
Clinical safety laboratory
Time Frame: up to 8 weeks
Haematology, biochemistry and urinalysis: changes and findings from Baseline in clinical safety laboratory parameters during the trial duration, from screening, and at follow-up visit.
up to 8 weeks

Collaborators and Investigators

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

Sponsor

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 (Actual)

June 20, 2017

Primary Completion (Actual)

September 27, 2017

Study Completion (Actual)

September 27, 2017

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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