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Clinical Trial Details

Trial ID: L3355
Source ID: NCT00850239
Associated Drug: Dutogliptin
Title: Safety and Efficacy Study of Dutogliptin/PHX1149T 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: placebo
Outcome Measures: Primary: Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline., 26 weeks | Secondary: Demonstrate safety and tolerability of dutogliptin, 26 weeks|• Demonstrate changes in fasting plasma glucose, 26 weeks
Sponsor/Collaborators: Sponsor: Phenomix | Collaborators: Forest Laboratories
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 700
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-05
Completion Date: 2010-12
Results First Posted:
Last Update Posted: 2010-08-11
Locations: Phenomix Investigational Site 115, 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 123, Chico, California, United States|Phenomix Investigational Site 134, Escondido, 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 119, Jacksonville, Florida, United States|Phenomix Investigational Site 133, Kissimmee, Florida, United States|Phenomix Investigational Site 141, Dunwoody, Georgia, 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 127, Indianapolis, Indiana, United States|Phenomix Investigational Site 136, Brockton, Massachusetts, United States|Phenomix Investigational Site 125, Kalamazoo, Michigan, 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 131, Brick, New Jersey, 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 130, Cincinnati, Ohio, United States|Phenomix Investigational Site 118, Cuyahoga Falls, Ohio, United States|Phenomix Investigational Site 112, Greenville, South Carolina, United States|Phenomix Investigational Site 102, Dallas, Texas, United States|Phenomix Investigational Site 139, Dallas, Texas, United States|Phenomix Investigational Site 126, El Paso, Texas, United States|Phenomix Investigational Site 104, San Antonio, Texas, United States|Phenomix Investigational Site 100, Kenosha, Wisconsin, United States|Phenomix Investigational Site 401, Buenos Aires, Argentina|Phenomix Investigational Site 402, Buenos Aires, Argentina|Phenomix Investigational Site 404, Buenos Aires, Argentina|Phenomix Investigational Site 405, Buenos Aires, Argentina|Phenomix Investigational Site 406, Buenos Aires, Argentina|Phenomix Investigational Site 407, Buenos Aires, Argentina|Phenomix Investigational Site 408, Buenos Aires, Argentina|Phenomix Investigational Site 409, Buenos Aires, Argentina|Phenomix Investigational Site 411, Buenos Aires, Argentina|Phenomix Investigational Site 403, Corrientes, Argentina|Phenomix Investigational Site 410, Mendoza, Argentina|Phenomix Investigational Site 400, Rosario, Argentina|Phenomix Investigational Site 502, Santiago, Chile|Phenomix Investigational Site 504, Santiago, Chile|Phenomix Investigational Site 505, Santiago, Chile|Phenomix Investigational Site 500, Temuco, Chile|Phenomix Investigational Site 501, Temuco, Chile|Phenomix Investigational Site 209, Chodov, Czech Republic|Phenomix Investigational Site 205, Havířov-Město, Czech Republic|Phenomix Investigational Site 204, Liberec, Czech Republic|Phenomix Investigational Site 202, Olomouc, Czech Republic|Phenomix Investigational Site 206, Ostrava Kunčice, Czech Republic|Phenomix Investigational Site 208, Praha, Czech Republic|Phenomix Investigational Site 203, Prostějov, Czech Republic|Phenomix Investigational Site 207, Uničov, Czech Republic|Phenomix Investigational Site 201, Valašské Klobouky, Czech Republic|Phenomix Investigational Site 703, Hyderabad, Andhara Pradesh, India|Phenomix Investigational Site 704, Visakhapatanam, Andhra Pradesh, India|Phenomix Investigational Site 709, Gopalapuram, Chennai, India|Phenomix Investigational Site 707, Shastrinagar, Jaipur, India|Phenomix Investigational Site 701, Bangalore, Karnataka, India|Phenomix Investigational Site 702, Bangalore, Karnataka, India|Phenomix Investigational Site 705, Trivandrum, Kerala, India|Phenomix Investigational Site 706, Indore, Madhya Pradesh, India|Phenomix Investigational Site 700, Nashik, Maharashtra, India|Phenomix Investigational Site 710, Navi Mumbai, Maharashtra, India|Phenomix Investigational Site 711, Mumbai, Maharastra, India|Phenomix Investigational Site 708, Chennai, India|Phenomix Investigational Site 607, Arequipa, Peru|Phenomix Investigational Site 605, Cercado de Lima, Peru|Phenomix Investigational Site 601, Ica, Peru|Phenomix Investigational Site 600, Lima, Peru|Phenomix Investigational Site 603, Lima, Peru|Phenomix Investigational Site 604, Lima, Peru|Phenomix Investigational Site 608, Lima, Peru|Phenomix Investigational Site 610, Lima, Peru|Phenomix Investigational Site 606, Piura, Peru|Phenomix Investigational Site 602, Trujillo, Peru|Phenomix Investigational Site 609, Wanchaq Cusco, Peru|Phenomix Investigational Site 300, Gdańsk, Poland|Phenomix Investigational Site 301, Gdańsk, Poland|Phenomix Investigational Site 303, Katowice, Poland|Phenomix Investigational Site 312, Katowice, Poland|Phenomix Investigational Site 309, Kraków, Poland|Phenomix Investigational Site 313, Kraków, Poland|Phenomix Investigational Site 308, Lublin, Poland|Phenomix Investigational Site 310, Poznan, Poland|Phenomix Investigational Site 306, Puławy, Poland|Phenomix Investigational Site 304, Szczecin, Poland|Phenomix Investigational Site 305, Warszawa, Poland|Phenomix Investigational Site 307, Warszawa, Poland|Phenomix Investigational Site 311, Warszawa, Poland|Phenomix Investigational Site 302, Wrocław, Poland
URL: https://clinicaltrials.gov/show/NCT00850239

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress