Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501107
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2020-08-03
Brief Title:
A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog and With EU Approved Humalog in Patients With Type 1 Diabetes Mellitus
Sponsor:
Adocia
Organization:
Adocia
Study Overview
Official Title:
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
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 02 UKg 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
The trial will compare the characteristics of BioChaperone insulin lispro fully liquid IMP2 formulation to US-approved Humalog and EU-approved Humalog
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None