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NCT Number: NCT02146651

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

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.

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Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Profil Institut für stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BioChaperone insulin lispro 0.2U/Kg

Drug

Single dose of 0.2U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.1U/Kg

Drug

Single dose of 0.1U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.4U/Kg

Drug

Single dose of 0.4U/Kg body weight injected subcutaneously

Humalog®

Drug

Single dose of 0.2U/Kg body weight injected subcutaneously

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 26, 2014
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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