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A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus

NCT04501107 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-11-30

No results posted yet for this study

Summary

This is a single-centre, randomised, double-blind, 4-way crossover, 4-treatment, euglycaemic clamp study in subjects with Type 1 Diabetes Mellitus (T1DM). Each subject will be randomly allocated to one of four treatment sequences. Each sequence comprises one single dose of each of four IMPs. IMP1 and IMP2 are BioChaperone lispro formulations. They have the same composition and correspond to different development stages of a unique product which is BioChaperone insulin lispro; between them, improvements were made to prepare industrial production. Comparators (IMP3 and IMP4) are US-approved Humalog® and EU-approved Humalog®. All IMPs will be dosed at 0.2 U/Kg of insulin lispro on 4 dosing visits separated by a washout period of 5 to 15 days.

The trial will compare the characteristics of BioChaperone insulin lispro fully liquid (IMP2) formulation to US-approved Humalog and EU-approved Humalog.

Conditions

Interventions

DRUG

Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1)

Administration of IMP1 during a 12-hour euglycaemic clamp.

DRUG

Administration of Ready-to-use BioChaperone insulin lispro (IMP2)

Administration of IMP2 during a 12-hour euglycaemic clamp.

DRUG

Administration of US-approved Humalog® (IMP3)

Administration of IMP3 during a 12-hour euglycaemic clamp.

DRUG

Administration of EU-approved Humalog® (IMP4)

Administration of IMP4 during a 12-hour euglycaemic clamp.

Sponsors & Collaborators

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Eugen Baumgaertner, MD · Profil GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2020-11-03
Completion
2020-11-03
FDA Drug
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT04501107 on ClinicalTrials.gov