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

NCT02660502 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-05-30

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Biochaperone insulin lispro 0.1 U/kg

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

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

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

DRUG

Humalog®

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

Sponsors & Collaborators

Principal Investigators

  • Grit Andersen, MD · Profil GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02660502 on ClinicalTrials.gov