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

NCT ID: NCT04501107

Last Updated: 2020-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2020-11-03

Brief 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

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BioChaperone insulin lispro reconstituted with Humalog® (IMP1)

Subcutaneous administration of Biochaperone insulin lispro formulation made from a freeze-dried of BioChaperone reconstituted with Humalog® at a dose of 0.2 U/Kg Body Weight (BW).

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Administration of IMP1 during a 12-hour euglycaemic clamp.

Ready-to-use BioChaperone insulin lispro (IMP2)

Subcutaneous administration of ready-to-use Biochaperone insulin lispro formulation at a dose of 0.2 U/Kg BW.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Administration of IMP2 during a 12-hour euglycaemic clamp.

US-approved Humalog® (IMP3)

Subcutaneous administration of US-approved Humalog® at a dose of 0.2 U/Kg BW.

Group Type: ACTIVE_COMPARATOR

Administration of US-approved Humalog® (IMP3)

Intervention Type: DRUG

Administration of IMP3 during a 12-hour euglycaemic clamp.

EU-approved Humalog® (IMP4)

Subcutaneous administration of EU-approved Humalog® at a dose of 0.2 U/Kg BW.

Group Type: ACTIVE_COMPARATOR

Administration of EU-approved Humalog® (IMP4)

Intervention Type: DRUG

Administration of IMP4 during a 12-hour euglycaemic clamp.

Interventions

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

Administration of IMP1 during a 12-hour euglycaemic clamp.

Intervention Type: DRUG

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

Administration of IMP2 during a 12-hour euglycaemic clamp.

Intervention Type: DRUG

Administration of US-approved Humalog® (IMP3)

Administration of IMP3 during a 12-hour euglycaemic clamp.

Intervention Type: DRUG

Administration of EU-approved Humalog® (IMP4)

Administration of IMP4 during a 12-hour euglycaemic clamp.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects with type 1 Diabetes Mellitus
• Body Mass Index (BMI) between 18.5 and 28.5 kg/m^2, both inclusive
• HbA1c <= 75 mmol/mol (<=9.0%).
• Fasting negative C-peptide (<= 0.30 nmol/L).
• Total insulin dose of < 1.2 (I)U/kg/day.
• Stable insulin regimen (with respect to safety of the subject and scientific integrity of the study) using continuous subcutaneous insulin infusion (CSII) or multiple daily insulin injections (MDI) for at least 2 months.

Exclusion Criteria

• Known or suspected hypersensitivity to IMP(s) or related products.
• Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator.
• Any history or presence of clinically relevant comorbidity capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data.
• Signs of acute illness as judged by the Investigator.
• Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the Investigator.
• Clinically significant abnormal screening laboratory tests, as judged by the Investigator.
• Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (<1.5 years) ophthalmologic examination.
• Use of oral antidiabetic drugs (OADs) and/or GLP-1 receptor agonists within 3 months prior to screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adocia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugen Baumgaertner, MD

Role: PRINCIPAL_INVESTIGATOR

Profil GmbH

Locations

Profil GmbH

Mainz, , Germany

Countries

Germany

Other Identifiers

CT037-ADO02

Identifier Type: -

Identifier Source: org_study_id