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A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02146651
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Adocia

Study Description
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Brief Summary:

The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.

The aim of the trial is to investigate the dose-response and the dose-exposure relationships of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.

This is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus.

Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of Humalog® (0.2 U/Kg) on 4 separate dosing visits.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Drug: BioChaperone insulin lispro 0.2U/Kg Drug: BioChaperone insulin lispro 0.1U/Kg Drug: BioChaperone insulin lispro 0.4U/Kg Drug: Humalog® Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
Study Start Date : May 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg
 Drug: BioChaperone insulin lispro 0.2U/Kg
Single dose of 0.2U/Kg body weight injected subcutaneously

Drug: BioChaperone insulin lispro 0.1U/Kg
Single dose of 0.1U/Kg body weight injected subcutaneously

Drug: BioChaperone insulin lispro 0.4U/Kg
Single dose of 0.4U/Kg body weight injected subcutaneously

Drug: Humalog®
Single dose of 0.2U/Kg body weight injected subcutaneously
Experimental: BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.1U/Kg
 Drug: BioChaperone insulin lispro 0.2U/Kg
Single dose of 0.2U/Kg body weight injected subcutaneously

Drug: BioChaperone insulin lispro 0.1U/Kg
Single dose of 0.1U/Kg body weight injected subcutaneously

Drug: BioChaperone insulin lispro 0.4U/Kg
Single dose of 0.4U/Kg body weight injected subcutaneously

Drug: Humalog®
Single dose of 0.2U/Kg body weight injected subcutaneously
Experimental: BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.4U/Kg
 Drug: BioChaperone insulin lispro 0.2U/Kg
Single dose of 0.2U/Kg body weight injected subcutaneously

Drug: BioChaperone insulin lispro 0.1U/Kg
Single dose of 0.1U/Kg body weight injected subcutaneously

Drug: BioChaperone insulin lispro 0.4U/Kg
Single dose of 0.4U/Kg body weight injected subcutaneously

Drug: Humalog®
Single dose of 0.2U/Kg body weight injected subcutaneously
Active Comparator: Humalog® 0.2U/Kg
Humalog® 0.2U/Kg
 Drug: BioChaperone insulin lispro 0.2U/Kg
Single dose of 0.2U/Kg body weight injected subcutaneously

Drug: BioChaperone insulin lispro 0.1U/Kg
Single dose of 0.1U/Kg body weight injected subcutaneously

Drug: BioChaperone insulin lispro 0.4U/Kg
Single dose of 0.4U/Kg body weight injected subcutaneously

Drug: Humalog®
Single dose of 0.2U/Kg body weight injected subcutaneously


Outcome Measures
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Primary Outcome Measures :
  1. Glucodynamic endpoint: Area Under the Curve GIR(0-last) [ Time Frame: 12 hours ]
    Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp

  2. Glucodynamic endpoint: GIRMax [ Time Frame: 12 hours ]
    Maximum Glucose Infusion Rate

  3. Pharmacokinetic endpoint: AUC Lisp(0-last) [ Time Frame: 12 hours ]
    Area under the insulin lispro serum concentration - time curve over the clamp procedure.

  4. Pharmacokinetic endpoint: Cmax(Lisp) [ Time Frame: 12 hours ]
    Maximum observed serum insulin lispro concentration


Secondary Outcome Measures :
  1. Pharmacokinetics: Tmax(lisp) [ Time Frame: 12 hours ]
    Time to maximum observed serum insulin lispro concentration

  2. Glucodynamic: TGIRmax [ Time Frame: 12 hours ]
    Time to maximum Glucose Infusion Rate

  3. Tonset of action [ Time Frame: 12 hours ]
    Time from t=0 until blood glucose concentration has decreased by 5mg.dL (0.3mmol.L) from baseline.

  4. Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters. [ Time Frame: 12 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus for at least 12 months
  • Treated with multiple daily insulin injections of insulin pump for at least 12 months
  • Body Mass Index (BMI): 18.5-28.0 Kg.m²

Exclusion Criteria:

  • Type 2 diabetes mellitus
  • Receipt of any investigational product within 3 months prior 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 as per investigator's judgement
  • Use of tobacco or nicotine-contained product within 1 year prior to screening
  • Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146651


Locations
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Germany
Profil Institut für stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
Investigators
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Principal Investigator: Grit Andersen, MD Profil Institut für Stoffwechselfforschung GmbH
More Information
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02146651    
Other Study ID Numbers: BC3-CT008
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs