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NCT Number: NCT02529293

A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers

This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.

Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
  • Age ≥ 18 and ≤ 64 years, both inclusive.
  • Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.
  • Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).
  • Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).

Exclusion criteria

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Receipt of any investigational medicinal product within 3 months before randomisation in this trial.

Treatment and study plan

BioChaperone Lispro U-100

Drug

Injection of BioChaperone Lispro U-100

BioChaperone Lispro U-200

Drug

Injection of BioChaperone Lispro U-200

Primary outcomes

  1. AUCLisp (0-inf)

    Time frame: 8 hours

    Area under the insulin lispro serum concentration - time curve from t=0 to infinity

  2. Cmax Lisp

    Time frame: 8 hours

    Maximum observed insulin lispro serum concentration

Secondary outcomes

  1. tmax Lisp

    Time frame: 8 hours

    Time to maximum observed serum insulin lispro concentration

  2. AUCGIR(0-8h)

    Time frame: 8 hours

    Area under the glucose infusion rate-time curve from t=0 to 8 hours

  3. GIRmax

    Time frame: 8 hours

    Maximum glucose infusion rate

  4. tGIRmax

    Time frame: 8 hours

    Time to maximum glucose infusion rate

  5. Number of Adverse events

    Time frame: Up to 9 weeks

    Number of adverse events

  6. Local tolerability

    Time frame: Up to 9 weeks

    Record of injection site reaction

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Registry information

Official study title

A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2015
Registry last updated
Dec 18, 2015

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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