Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-05 @ 5:10 AM
Study NCT ID:
NCT00411892
Status:
TERMINATED
Last Update Posted:
2018-09-05
First Post:
2006-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes
Sponsor:
Novo Nordisk A/S
Organization:
Study Overview
Official Title:
Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes
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). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.
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:
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?: