Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322257
Status:
TERMINATED
Last Update Posted:
2018-09-05
First Post:
2006-05-03
Brief Title:
Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
Inhaled Mealtime Insulin With the AERx iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes A 104 Week Open-Label Multicenter Randomised Parallel Trial Followed by a Twelve-Week Re-Randomised Extension To Investigate Safety and Efficacy
Status:
TERMINATED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is conducted in the United States of America USA and Canada The aim of this research is to compare the efficacy reduction in HbA1c and blood glucose and pulmonary safety pulmonary function chest x-rays of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes
Detailed Description:
The decision to discontinue the development of AERx is not due to any safety concerns An analysis concluded that fast-acting inhaled insulin in the form it is known today is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices
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