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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

August 3, 2020

Primary Completion Date

November 3, 2020

Study Completion Date

November 3, 2020

Conditions
Type 1 Diabetes
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.

Trial Locations (1)

D-55116

Profil GmbH, Mainz

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Adocia

INDUSTRY