Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
- Registration Number
- NCT00998686
- Lead Sponsor
- Phenomix
- Brief Summary
The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 650
- Completion of all required visits of a qualifying Phase 3 core protocol
- Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sitagliptin sitagliptin - dutogliptin/PHX1149T dutogliptin -
- Primary Outcome Measures
Name Time Method To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG 52 weeks
- Secondary Outcome Measures
Name Time Method To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose 52 weeks
Trial Locations
- Locations (43)
Phenomix Investigational Site 208
🇨🇿Praha 10, Czech Republic
Phenomix Investigational Site 300
🇵🇱Gdansk, Poland
Phenomix Investigational Site 306
🇵🇱Pulawy, Poland
Phenomix Investigational Site 305
🇵🇱Warszawa, Poland
Phenomix Investigational Site 706
🇮🇳Indore, Madhya Pradesh, India
Phenomix Investigational Site 138
🇺🇸Biloxi, Mississippi, United States
Phenomix Investigational Site 601
🇵🇪Ica, Peru
Phenomix Investigational Site 604
🇵🇪Lima, Peru
Phenomix Investigational Site 707
🇮🇳Shastrinagar, Jaipur, India
Phenomix Investigational Site 110
🇺🇸Trenton, New Jersey, United States
Phenomix Investigational Site 701
🇮🇳Bangalore, Karnataka, India
Phenomix Investigational Site 112
🇺🇸Greenville, South Carolina, United States
Phenomix Investigational Site 402
🇦🇷Buenos Aires, Argentina
Phenomix Investigational Site 607
🇵🇪Arequipa, Peru
Phenomix Investigational Site 103
🇺🇸Long Beach, California, United States
Phenomix Investigational Site 143
🇺🇸Coral Gables, Florida, United States
Phenomix Investigational Site 136
🇺🇸Brockton, Massachusetts, United States
Phenomix Investigational Site 309
🇵🇱Karkow, Poland
Phenomix Investigational Site 303
🇵🇱Katowice, Poland
Phenomix Investigational Site 705
🇮🇳Trivandrum, Kerala, India
Phenomix Investigational Site 302
🇵🇱Wroclaw, Poland
Phenomix Investigational Site 610
🇵🇪Lima, Peru
Phenomix Investigational Site 408
🇦🇷Buenos Aires, Argentina
Phenomix Investigational Site 209
🇨🇿Praha 4 Chodov, Czech Republic
Phenomix Investigational Site 410
🇦🇷Mendoza, Argentina
Phenomix Investigational Site 207
🇨🇿Unicov, Czech Republic
Phenomix Investigational Site 105
🇺🇸Anaheim, California, United States
Phenomix Investigational Site 121
🇺🇸Tempe, Arizona, United States
Phenomix Investigational Site 137
🇺🇸Tempe, Arizona, United States
Phenomix Investigational Site 106
🇺🇸Los Angeles, California, United States
Phenomix Investigational Site 142
🇺🇸Hialeah, Florida, United States
Phenomix Investigational Site 133
🇺🇸Kissimmee, Florida, United States
Phenomix Investigational Site 101
🇺🇸Honolulu, Hawaii, United States
Phenomix Investigational Site 135
🇺🇸Chicago, Illinois, United States
Phenomix Investigational Site 124
🇺🇸Indianapolis, Indiana, United States
Phenomix Investigational Site 122
🇺🇸Las Vegas, Nevada, United States
Phenomix Investigational Site 140
🇺🇸Las Vegas, Nevada, United States
Phenomix Investigational Site 116
🇺🇸Albuquerque, New Mexico, United States
Phenomix Investigational Site 107
🇺🇸Winston-Salem, North Carolina, United States
Phenomix Investigational Site 102
🇺🇸Dallas, Texas, United States
Phenomix Investigational Site 104
🇺🇸San Antonio, Texas, United States
Phenomix Investigational Site 100
🇺🇸Kenosha, Wisconsin, United States
Phenomix Investigational Site 711
🇮🇳Mumbai, Maharashtra, India