Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- To demonstrate safety and tolerability of dutogliptin [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
- To demonstrate maintenance or lowering of HbA1c [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
- To demonstrate maintenance or lowering of fasting blood glucose [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||March 2011|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
- dutogliptin tartrate
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.
Show 68 Study Locations