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Completed

NCT Number: NCT02213146

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

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.

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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 / Phase 2

Primary location

Profil GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BioChaperone human insulin

Drug

Single dose of 0.2 U/kg body weight injected subcutaneously

Huminsulin® Normal

Drug

Single dose of 0.2 U/kg body weight injected subcutaneously

Humalog®

Drug

Single dose of 0.2 U/kg body weight injected subcutaneously

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)

    Time frame: 10 hours

    Time to first observed half maximum glucose infusion rate

  4. Glucodynamics: GIRmax - Maximum glucose infusion rate

    Time frame: 10 hours

    Maximum glucose infusion rate

  5. 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

  6. 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

  7. 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

  8. Pharmacokinetics: Cmax(ins/lisp)

    Time frame: up to 10 hours

    Maximum observed human insulin / insulin lispro serum concentration

  9. 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

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Aug 11, 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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