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

Stopped early · Phase 3

Conditions studied: Type 2 Diabetes Mellitus, Type 2 Diabetes

In brief

The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

Key facts

Study ID

NCT00865592

Run by

Phenomix

People needed

450

Starts

2009-03-01

Expected to finish

2011-03-01

Last updated by the study team

2010-08-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301)
• Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301

You may not qualify if…

• Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
• 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

Where it is running

• Study site — Orange, California, United States
• Study site — Santa Ana, California, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Atlanta, Georgia, United States
• Phenomix Investigational Site 663 — Honolulu, Hawaii, United States
• Study site — Brockton, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Cincinnati, Ohio, United States
• Study site — El Paso, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Norfolk, Virginia, United States
• Phenomix Investigational Site 103 — Buenos Aires, Argentina
• Phenomix Investigational Site 110 — Buenos Aires, Argentina
• Phenomix Investigational Site 111 — Buenos Aires, Argentina
• Phenomix Investigational Site 106 — Caba, Argentina
• Phenomix Investigational Site 112 — Corrientes, Argentina
• Phenomix Investigational Site 102 — Paraná, Argentina
• Study site — Bangalore, Karnataka, India
• Study site — Chennai, Tamil Nadu, India
• Study site — Gulbarga, Karnataka, India
• Study site — Hyderabad, Andhara Pradesh, India
• Study site — Mumbai, Maharashtra, India
• Study site — Nagpur, Maharashtra, India
• Study site — Norwalk, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.