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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Biochaperone insulin lispro 0.2 U/kg; Drug: Biochaperone insulin lispro 0.4 U/kg; Drug: Humalog®; Drug: Biochaperone insulin lispro 0.1 U/kg

• Registration Number: NCT02660502
• Lead Sponsor: Adocia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-21
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BioChaperone insulin lispro 0.2 U/kg	Biochaperone insulin lispro 0.2 U/kg	-
BioChaperone insulin lispro 0.4 U/kg	Biochaperone insulin lispro 0.4 U/kg	-
Humalog®	Humalog®	-
BioChaperone insulin lispro 0.1 U/kg	Biochaperone insulin lispro 0.1 U/kg	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany