Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-03-05 @ 1:04 AM
Study NCT ID:
NCT02344992
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2015-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
Sponsor:
Adocia
Organization:
Study Overview
Official Title:
Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
Status:
COMPLETED
Status Verified Date:
2015-06
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:
The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.
This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.
This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.
This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.
This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-005028-92 | EUDRACT_NUMBER | None | View |