Clinical Trials Directory

Trials / Terminated

TerminatedNCT00865592

Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

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
Phase
Phase 3
Study type
Interventional
Enrollment
450 (estimated)
Sponsor
Phenomix · Industry
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGdutogliptindutogliptin 400 mg, once daily tablet

Timeline

Start date
2009-03-01
Primary completion
2011-01-01
Completion
2011-03-01
First posted
2009-03-19
Last updated
2010-08-11

Locations

68 sites across 8 countries: United States, Argentina, India, Malaysia, Peru, Philippines, Romania, Ukraine

Source: ClinicalTrials.gov record NCT00865592. Inclusion in this directory is not an endorsement.