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Completed

NCT Number: NCT02660502

An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.

Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits.

The total trial maximum duration for a subject will be up to 10 weeks.

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Key information

Conditions

Age range

20 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

  • Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
  • BMI between 18.5 and 25.0 kg∙m-2, both inclusive.
  • Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL).
  • Signed and dated informed consent obtained before any trial-related activities.

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.
  • Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

Treatment and study plan

Biochaperone insulin lispro 0.1 U/kg

Drug

Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg

Biochaperone insulin lispro 0.2 U/kg

Drug

Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg

Biochaperone insulin lispro 0.4 U/kg

Drug

Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg

Humalog®

Drug

Injection of a single dose of Humalog® at the dose of 0.2 U/kg

Primary outcomes

  1. AUCLispro(0-30min)

    Time frame: Up to 30 minutes

    Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes

Secondary outcomes

  1. AUCGIR(0-last)

    Time frame: Up to 8 hours

    Area under the glucose infusion rate time curve from 0 hours until the end of clamp

  2. Adverse Events

    Time frame: Up to 10 weeks

    Number of adverse events

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 21, 2016
Registry last updated
May 30, 2016

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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