Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427154
Status:
TERMINATED
Last Update Posted:
2018-09-05
First Post:
2007-01-25
Brief Title:
Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin Glimepiride Versus Rosiglitazone Plus Metformin Glimepiride 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 or rosiglitazone treatment both in combination with metformin and glimepiride
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