NCT04501107

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

A Randomised, Double Blind, Crossover Euglycaemic Clamp Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-03
• Primary completion: 2020-11-03
• Completion: 2020-11-03
• First posted: 2020-08-06
• Last updated: 2020-11-30

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study