Status:
TERMINATED
Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Lead Sponsor:
Phenomix
Collaborating Sponsors:
Forest Laboratories
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.
Eligibility Criteria
Inclusion
- Completion of all required visits of a qualifying Phase 3 core protocol
- Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302
Exclusion
- Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00998686
Start Date
November 1 2009
End Date
November 1 2011
Last Update
August 11 2010
Active Locations (44)
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1
Phenomix Investigational Site 105
Montgomery, Alabama, United States
2
Phenomix Investigational Site 121
Tempe, Arizona, United States
3
Phenomix Investigational Site 137
Tempe, Arizona, United States
4
Phenomix Investigational Site 105
Anaheim, California, United States