Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424333
Status:
COMPLETED
Last Update Posted:
2007-02-13
First Post:
2007-01-17
Brief Title:
Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin in an Intensive Insulin Regimen for Subjects With Type 1 Diabetes Mellitus A Six-Month Outpatient Parallel Comparative Trial
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine in subjects with Type 1 Diabetes Mellitus
1 Whether glycemic control can be achieved at least as effectively with a an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH given as 4 injections per day The treatment regimens differ only by the route of delivery of the short acting insulin
2 The toleration and safety of inhaled insulin therapy and its effects after 6months if any on measures of pulmonary function
1 Whether glycemic control can be achieved at least as effectively with a an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH given as 4 injections per day The treatment regimens differ only by the route of delivery of the short acting insulin
2 The toleration and safety of inhaled insulin therapy and its effects after 6months if any on measures of pulmonary function
Detailed Description:
None
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