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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02660502

Enrollment

Registered

2016-01-21

Start date

2016-01-31

Completion date

2016-05-31

Last updated

2016-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGBiochaperone insulin lispro 0.1 U/kg

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

DRUGBiochaperone insulin lispro 0.2 U/kg

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

DRUGBiochaperone insulin lispro 0.4 U/kg

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

DRUGHumalog®

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
AUCLispro(0-30min)	Up to 30 minutes	Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes

Secondary

Measure	Time frame	Description
AUCGIR(0-last)	Up to 8 hours	Area under the glucose infusion rate time curve from 0 hours until the end of clamp
Adverse Events	Up to 10 weeks	Number of adverse events

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026