A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

May 31, 2017 updated by: Adocia

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.

The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg.

This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 separate dosing visits.

Study Overview

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • 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 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

Male

Description

Inclusion Criteria:

  • Male subject with type 1 diabetes for at least 12 months
  • Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months
  • Body mass index: 18.5-28.0 kg BW·m-2
  • HbA1c: ≤ 9.0%

Exclusion Criteria:

  • Diabetes mellitus type 2
  • Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial
  • 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 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BioChaperone human insulin
BioChaperone Human Insulin
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
Active Comparator: Human insulin
Huminsulin® Normal
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
Active Comparator: Insulin lispro
Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
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 curve (AUCins(0-1h))
Time Frame: 1 hour
Area under the human insulin serum concentration - time curve from t=0 to 1 hour
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics: Early t0.5max ins/lisp
Time Frame: up to 10 hours post administration
Time to first observed half maximum serum human insulin / insulin lispro concentration
up to 10 hours post administration
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours
Time Frame: 10 hours
Area under the glucose infusion rate - time curve from t=0 to 10 hours
10 hours
Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)
Time Frame: 10 hours
Time to first observed half maximum glucose infusion rate
10 hours
Glucodynamics: GIRmax - Maximum glucose infusion rate
Time Frame: 10 hours
Maximum glucose infusion rate
10 hours
Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration
Time Frame: 10 hours
Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours
10 hours
Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration
Time Frame: 10 hours
Time to maximum observed serum human insulin concentration and insulin lispro concentration
10 hours
Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Time Frame: up to 7 weeks
Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
up to 7 weeks
Pharmacokinetics: Cmax(ins/lisp)
Time Frame: up to 10 hours
Maximum observed human insulin / insulin lispro serum concentration
up to 10 hours
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours
Time Frame: 2 hours post administration
Area under the glucose infusion rate - time curve from t=0 to 2 hours
2 hours post administration

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

August 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimate)

August 11, 2014

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

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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