Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 3:23 PM
Study NCT ID:
NCT02739906
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM
Sponsor:
Adocia
Organization:
Study Overview
Official Title:
A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)
Status:
COMPLETED
Status Verified Date:
2016-08
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 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.
Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.
Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.
The total trial duration for an individual subject will be up to 11 weeks.
Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.
Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.
The total trial duration for an individual subject will be up to 11 weeks.
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?: