Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 11:55 PM
Study NCT ID:
NCT00127634
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2005-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A Pivotal Long-Term, Open-Label, Parallel Study of the Efficacy and Safety of Human Insulin Inhalation Powder 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:
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| H7U-MC-IDAH | None | None | View |