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Clinical Trial Details

Trial ID: L2999
Source ID: NCT00998686
Associated Drug: Dutogliptin
Title: Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: dutogliptin|DRUG: sitagliptin
Outcome Measures: Primary: To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG, 52 weeks | Secondary: To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose, 52 weeks
Sponsor/Collaborators: Sponsor: Phenomix | Collaborators: Forest Laboratories
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 650
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-11
Completion Date: 2011-11
Results First Posted:
Last Update Posted: 2010-08-11
Locations: Phenomix Investigational Site 105, Montgomery, Alabama, United States|Phenomix Investigational Site 121, Tempe, Arizona, United States|Phenomix Investigational Site 137, Tempe, Arizona, United States|Phenomix Investigational Site 105, Anaheim, California, United States|Phenomix Investigational Site 103, Long Beach, California, United States|Phenomix Investigational Site 106, Los Angeles, California, United States|Phenomix Investigational Site 143, Coral Gables, Florida, 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 136, Brockton, Massachusetts, United States|Phenomix Investigational Site 138, Biloxi, Mississippi, United States|Phenomix Investigational Site 122, Las Vegas, Nevada, United States|Phenomix Investigational Site 140, Las Vegas, Nevada, United States|Phenomix Investigational Site 110, Trenton, New Jersey, United States|Phenomix Investigational Site 116, Albuquerque, New Mexico, United States|Phenomix Investigational Site 107, Winston-Salem, North Carolina, United States|Phenomix Investigational Site 112, Greenville, South 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 402, Buenos Aires, Argentina|Phenomix Investigational Site 408, Buenos Aires, Argentina|Phenomix Investigational Site 410, Mendoza, Argentina|Phenomix Investigational Site 208, Praha 10, Czech Republic|Phenomix Investigational Site 209, Praha 4 Chodov, Czech Republic|Phenomix Investigational Site 207, Unicov, Czech Republic|Phenomix Investigational Site 707, Shastrinagar, Jaipur, India|Phenomix Investigational Site 701, Bangalore, Karnataka, India|Phenomix Investigational Site 705, Trivandrum, Kerala, India|Phenomix Investigational Site 706, Indore, Madhya Pradesh, India|Phenomix Investigational Site 711, Mumbai, Maharashtra, India|Phenomix Investigational Site 607, Arequipa, Peru|Phenomix Investigational Site 601, Ica, Peru|Phenomix Investigational Site 604, Lima, Peru|Phenomix Investigational Site 610, Lima, Peru|Phenomix Investigational Site 300, Gdansk, Poland|Phenomix Investigational Site 309, Karkow, Poland|Phenomix Investigational Site 303, Katowice, Poland|Phenomix Investigational Site 306, Pulawy, Poland|Phenomix Investigational Site 305, Warszawa, Poland|Phenomix Investigational Site 302, Wroclaw, Poland
URL: https://clinicaltrials.gov/show/NCT00998686