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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

NCT ID: NCT02529293

Last Updated: 2015-12-18

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-11-30

Brief Summary

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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.

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

TRIPLE

Participants Caregivers Investigators

Study Groups

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BioChaperone Lispro U-100

injection of 2 doses of 0.2 U/kg on separate visits

Group Type ACTIVE_COMPARATOR

BioChaperone Lispro U-100

Intervention Type DRUG

Injection of BioChaperone Lispro U-100

BioChaperone Lispro U-200

injection of 2 doses of 0.2 U/kg on separate visits

Group Type EXPERIMENTAL

BioChaperone Lispro U-200

Intervention Type DRUG

Injection of BioChaperone Lispro U-200

Interventions

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BioChaperone Lispro U-100

Injection of BioChaperone Lispro U-100

Intervention Type DRUG

BioChaperone Lispro U-200

Injection of BioChaperone Lispro U-200

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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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 Institut Für Stoffwechselfforschung 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-CT012

Identifier Type: -

Identifier Source: org_study_id