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Completed

NCT Number: NCT02029924

A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) 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 a facilitation of the absorption of the insulin after subcutaneous injection.

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

This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 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 1

Primary location

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 or insulin pump for at least 12 months.
  • Body Mass Index (BMI): 18.0-28.0 Kg/m².

Exclusion criteria

  • Type 2 diabetes mellitus.
  • Receipt of any investigational product within 3 months prior to 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 5 years prior to screening.
  • Blood or plasma donation in the past month or more than 500 mL within 3 months prior to screening.

Treatment and study plan

BioChaperone insulin lispro

Drug

Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)

Humalog®

Drug

Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)

Primary outcomes

  1. Area under the curve (AUC)

    Time frame: 30 minutes

    Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes

Secondary outcomes

  1. Pharmacokinetics: Early t0.5max(Lisp)

    Time frame: up to 6 hours post administration of study drug

    Time to first observed half maximum observed insulin lispro concentration

  2. Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours

    Time frame: 6 hours

  3. Glucodynamics: Early t0.5(GIRmax)

    Time frame: 6 hours

    Time to first observed half maximum glucose infusion rate

  4. Glucodynamic: GIRmax (Maximum glucose infusion rate)

    Time frame: 6 hours

  5. Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours

    Time frame: 6 hours

  6. Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration

    Time frame: 6 hours

  7. Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 8, 2014
Registry last updated
Jun 1, 2017

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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