Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137046
Status:
TERMINATED
Last Update Posted:
2010-02-18
First Post:
2005-08-26
Brief Title:
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Efficacy and Safety of Exubera Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 1 Diabetes Mellitus A Long-Term Outpatient Open-Label Parallel-Group Comparative Trial
Status:
TERMINATED
Status Verified Date:
2009-12
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 study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus The drug is called EXUBERA inhaled insulin
This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin After this follow-up period all eligible subjects entered a comparative extension period that was to last for 5 years When the comparative portion of the study was terminated all subjects were requested to return for a final extension follow-up month 3 visit
This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin After this follow-up period all eligible subjects entered a comparative extension period that was to last for 5 years When the comparative portion of the study was terminated all subjects were requested to return for a final extension follow-up month 3 visit
Detailed Description:
Pfizer announced in October 2007 that it would stop marketing Exubera Nektar the company from which Pfizer licensed Exubera announced on April 9 2008 that it had stopped its search for a new marketing partner Accordingly there will be no commercial availability of Exubera As a result study A2171022 was terminated on June 9 2008 Neither safety nor efficacy reasons were the cause of the study termination
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