NCT02660502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 30, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

January 18, 2016

Last Update Submit

May 27, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • AUCLispro(0-30min)

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

    Up to 30 minutes

Secondary Outcomes (2)

  • AUCGIR(0-last)

    Up to 8 hours

  • Adverse Events

    Up to 10 weeks

Study Arms (4)

BioChaperone insulin lispro 0.1 U/kg

EXPERIMENTAL
Drug: Biochaperone insulin lispro 0.1 U/kg

BioChaperone insulin lispro 0.2 U/kg

EXPERIMENTAL
Drug: Biochaperone insulin lispro 0.2 U/kg

BioChaperone insulin lispro 0.4 U/kg

EXPERIMENTAL
Drug: Biochaperone insulin lispro 0.4 U/kg

Humalog®

ACTIVE COMPARATOR
Drug: Humalog®

Interventions

Biochaperone insulin lispro 0.1 U/kgDRUG

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

BioChaperone insulin lispro 0.1 U/kg
Biochaperone insulin lispro 0.2 U/kgDRUG

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

BioChaperone insulin lispro 0.2 U/kg
Biochaperone insulin lispro 0.4 U/kgDRUG

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

BioChaperone insulin lispro 0.4 U/kg
Humalog®DRUG

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

Humalog®

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Interventions

Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Grit Andersen, MD

    Profil GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 21, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 30, 2016

Record last verified: 2016-01

Locations

DE(1)