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

NCT ID: NCT02660502

Last Updated: 2016-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BioChaperone insulin lispro 0.1 U/kg

Group Type EXPERIMENTAL

Biochaperone insulin lispro 0.1 U/kg

Intervention Type 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

Group Type EXPERIMENTAL

Biochaperone insulin lispro 0.2 U/kg

Intervention Type 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

Group Type EXPERIMENTAL

Biochaperone insulin lispro 0.4 U/kg

Intervention Type DRUG

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

Humalog®

Group Type ACTIVE_COMPARATOR

Humalog®

Intervention Type DRUG

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

Interventions

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Biochaperone insulin lispro 0.1 U/kg

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

Intervention Type DRUG

Biochaperone insulin lispro 0.2 U/kg

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

Intervention Type DRUG

Biochaperone insulin lispro 0.4 U/kg

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

Intervention Type DRUG

Humalog®

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Adocia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grit Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Profil GmbH

Locations

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Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BC3-CT017

Identifier Type: -

Identifier Source: org_study_id