Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356109
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2006-07-21
Brief Title:
Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase 3 Open-Label Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder HIIP Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2018-03
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:
A study to test for non-inferiority of preprandial HIIP also known as AIR Inhaled Insulin PowderAIR is a registered trademark of AlkermesInc compared with preprandial injectable insulin insulin lispro with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus
This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes
The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin insulin lispro with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes
This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes
The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin insulin lispro with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H7U-MC-IDAV | None | None | None |