Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-25 @ 1:26 PM
Study NCT ID:
NCT00875459
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2009-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label, Multi-Center, Follow-on Study Examining the Long-Term Safety and Efficacy of Insulin VIAject™ in Subjects With Type 1 Diabetes Mellitus
Sponsor:
Biodel
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-07
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:
Follow-on study to the VIAject™ 06J study to evaluate the long-term safety and efficacy of VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 1 diabetes mellitus.
The VIAject™ 06J study is the efficacy and safety study for insulin VIAject™ to demonstrate equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to human insulin
The VIAject™ 06J study is the efficacy and safety study for insulin VIAject™ to demonstrate equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to human insulin
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?: