Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:34 AM
Study NCT ID:
NCT00865592
Status:
TERMINATED
Last Update Posted:
2010-08-11
First Post:
2009-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
Sponsor:
Phenomix
Organization:
Study Overview
Official Title:
An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus
Status:
TERMINATED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
Detailed Description:
In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.
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?: