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Clinical Trial Details

Trial ID: L3158
Source ID: NCT00947557
Associated Drug: Dutogliptin
Title: Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type II
Interventions: DRUG: Dutogliptin|DRUG: Placebo
Outcome Measures: Primary: Hemoglobin A1c (HbA1c), HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26). | Secondary: Fasting Plasma Glucose (FPG), FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26).
Sponsor/Collaborators: Sponsor: Forest Laboratories | Collaborators: Phenomix
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 677
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-07
Completion Date:
Results First Posted:
Last Update Posted: 2011-09-21
Locations: Forest Investigative Site 064, Birmingham, Alabama, 35205, United States|Forest Investigative Site 020, Birmingham, Alabama, 35235, United States|Forest Investigative Site 025, Muscle Shoals, Alabama, 35661, United States|Forest Investigative Site 059, Chandler, Arizona, 85225, United States|Forest Investigative Site 113, Gilbert, Arizona, 85295, United States|Forest Investigative Site 096, Litchfield, Arizona, 85340, United States|Forest Investigative Site 080, Peoria, Arizona, 85381, United States|Forest Investigative Site 098, Phoenix, Arizona, 85020, United States|Forest Investigative Site 044, Scottsdale, Arizona, 85254, United States|Forest Investigative Site 061, Anaheim, California, 92801, United States|Forest Investigative Site 041, Chula Vista, California, 91911, United States|Forest Investigative Site 049, Encinitas, California, 92024, United States|Forest Investigative Site 022, Greenbrae, California, 94904, United States|Forest Investigative Site 047, Harbor City, California, 90710, United States|Forest Investigative Site 010, Huntington Park, California, 90255, United States|Forest Investigative Site 070, Los Angeles, California, 90057, United States|Forest Investigative Site 111, Northridge, California, 91325, United States|Forest Investigative Site 031, Riverside, California, 92506, United States|Forest Investigative Site 091, Roseville, California, 95661, United States|Forest Investigative Site 067, Sacramento, California, 95821, United States|Forest Investigative Site 112, Santa Ana, California, 92701, United States|Forest Investigative Site 011, Walnut Creek, California, 94598, United States|Forest Investigative Site 063, West Hills, California, 91307, United States|Forest Investigative Site 088, Denver, Colorado, 80239, United States|Forest Investigative Site 156, Boca Raton, Florida, 33432, United States|Forest Investigative Site 004, Daytona Beach, Florida, 32117, United States|Forest Investigative Site 052, DeLand, Florida, 32720, United States|Forest Investigative Site 129, Hollywood, Florida, 33021, United States|Forest Investigative Site 062, Jacksonville, Florida, 32205, United States|Forest Investigative Site 125, Miami Lakes, Florida, 33014, United States|Forest Investigative Site 050, Miami, Florida, 33156, United States|Forest Investigative Site 021, Miami, Florida, 33169, United States|Forest Investigative Site 122, Miami, Florida, 33186, United States|Forest Investigative Site 069, New Port Richey, Florida, 34652, United States|Forest Investigative Site 012, Ocala, Florida, 34471, United States|Forest Investigative Site 015, Orlando, Florida, 32806, United States|Forest Investigative Site 131, Ormond Beach, Florida, 32174, United States|Forest Investigative Site 127, Pembroke Pines, Florida, 33028, United States|Forest Investigative Site 018, Sarasota, Florida, 34239, United States|Forest Investigative Site 075, St. Petersburg, Florida, 33716, United States|Forest Investigative Site 026, West Palm Beach, Florida, 33401, United States|Forest Investigative Site 045, Atlanta, Georgia, 30338, United States|Forest Investigative Site 079, Augusta, Georgia, 30909, United States|Forest Investigative Site 084, Roswell, Georgia, 30076, United States|Forest Investigative Site 132, Roswell, Georgia, 30076, United States|Forest Investigative Site 009, Meridian, Idaho, 83646, United States|Forest Investigative Site 030, Peoria, Illinois, 61614, United States|Forest Investigative Site 100, Evansville, Indiana, 47710, United States|Forest Investigative Site 097, Evansville, Indiana, 47713, United States|Forest Investigative Site 053, Kansas City, Kansas, 66160, United States|Forest Investigative Site 008, Wichita, Kansas, 67203, United States|Forest Investigative Site 107, Lexington, Kentucky, 40504, United States|Forest Investigative Site 034, Covington, Louisiana, 70433, United States|Forest Investigative Site 035, Baltimore, Maryland, 21204, United States|Forest Investigative Site 046, Oxon Hill, Maryland, 20745, United States|Forest Investigative Site 003, Brockton, Massachusetts, 02301, United States|Forest Investigative Site 055, Brockton, Massachusetts, 23301, United States|Forest Investigative Site 118, New Bedford, Massachusetts, 02740, United States|Forest Investigative Site 007, Waltham, Massachusetts, 24453, United States|Forest Investigative Site 002, Dearborn, Michigan, 48126, United States|Forest Investigative Site 029, St. Clair Shores, Michigan, 48081, United States|Forest Investigative Site 054, Edina, Minnesota, 55435, United States|Forest Investigative Site 072, Las Vegas, Nevada, 89101, United States|Forest Investigative Site 065, Las Vegas, Nevada, 89117, United States|Forest Investigative Site 101, Albuquerque, New Mexico, 87108, United States|Forest Investigative Site 081, New Hyde Park, New York, 11042, United States|Forest Investigative Site 016, New York, New York, 10019, United States|Forest Investigative Site 094, Charlotte, North Carolina, 28204, United States|Forest Investigative Site 051, Charlotte, North Carolina, 28209, United States|Forest Investigative Site 058, Lenoir, North Carolina, 28645, United States|Forest Investigative Site 038, Morehead City, North Carolina, 28557, United States|Forest Investigative Site 040, Salisbury, North Carolina, 28144, United States|Forest Investigative Site 082, Winston-Salem, North Carolina, 27103, United States|Forest Investigative Site 039, Akron, Ohio, 44311, United States|Forest Investigative Site 023, Cincinnati, Ohio, 45242, United States|Forest Investigative Site 043, Columbus, Ohio, 43201, United States|Forest Investigative Site 057, Dayton, Ohio, 45406, United States|Forest Investigative Site 032, Kettering, Ohio, 45429, United States|Forest Investigative Site 083, Bethany, Oklahoma, 73008, United States|Forest Investigative Site 005, Eugene, Oregon, 97404, United States|Forest Investigative Site 001, Medford, Oregon, 97504, United States|Forest Investigative Site 126, Jenkintown, Pennsylvania, 19046, United States|Forest Investigative Site 066, Philadelphia, Pennsylvania, 19152, United States|Forest Investigative Site 036, Tipton, Pennsylvania, 16684, United States|Forest Investigative Site 103, Greer, South Carolina, 29651, United States|Forest Investigative Site 033, Pelzer, South Carolina, 29669, United States|Forest Investigative Site 114, Chattanooga, Tennessee, 37404, United States|Forest Investigative Site 104, Chattanooga, Tennessee, 37421, United States|Forest Investigative Site 099, Arlington, Texas, 76014, United States|Forest Investigative Site 056, Corpus Christi, Texas, 78404, United States|Forest Investigative Site 071, Dallas, Texas, 75230, United States|Forest Investigative Site 017, Dallas, Texas, 75235, United States|Forest Investigative Site 014, Irving, Texas, 75039, United States|Forest Investigative Site 109, San Antonio, Texas, 78229, United States|Forest Investigative Site 119, San Antonio, Texas, 78258, United States|Forest Investigative Site 076, Salt Lake City, Utah, 84107, United States|Forest Investigative Site 028, Virginia Beach, Virginia, 23454, United States|Forest Investigative Site 068, Renton, Washington, 98057, United States|Forest Investigative Site 202, Gomel, 236029, Belarus|Forest Investigative Site 208, Grodno, 230015, Belarus|Forest Investigative Site 207, Minsk, 220114, Belarus|Forest Investigative Site 209, Mogilev, 212030, Belarus|Forest Investigative Site 206, Vitebsk, 210037, Belarus|Forest Investigative Site 302, Medellin, Antioquia, Colombia|Forest Investigative Site 506, Budapest, H-1083, Hungary|Forest Investigative Site 504, Szentes, H-6600, Hungary|Forest Investigative Site 621, Hyderabad, Andhra Pradesh, 500034, India|Forest Investigative Site 614, Vijayawada, Andhra Pradesh, 520002, India|Forest Investigative Site 610, Visakhapatanam, Andhra Pradesh, 530002, India|Forest Investigative Site 609, Mapusa, Goa, 403507, India|Forest Investigative Site 618, Ahmedabad, Gujarat, 380015, India|Forest Investigative Site 620, Haryana, Karnal, 132001, India|Forest Investigative Site 607, Bangalore, Karnataka, 560003, India|Forest Investigative Site 606, Bangalore, Karnataka, 560010, India|Forest Investigative Site 602, Bangalore, Karnataka, 560043, India|Forest Investigative Site 604, Bangalore, Karnataka, 560092, India|Forest Investigative Site 601, Mangalore, Karnataka, 575003, India|Forest Investigative Site 619, Palakkad, Kerala, 678013, India|Forest Investigative Site 616, Nagpur, Maharashtra, 440012, India|Forest Investigative Site 617, Nasik, Maharashtra, 380015, India|Forest Investigative Site 612, Pune, Maharashtra, 411037, India|Forest Investigative Site 603, Channi, Tamil Nadu, 600020, India|Forest Investigative Site 613, Chennai, Tamil Nadu, 600013, India|Forest Investigative Site 615, Vellore, Tamil Nadu, 632009, India|Forest Investigative Site 702, Kaunas, 48259, Lithuania|Forest Investigative Site 703, Kaunas, 49456, Lithuania|Forest Investigative Site 701, Kaunas, 51270, Lithuania|Forest Investigative Site 704, Klaipeda, 92288, Lithuania|Forest Investigative Site 705, Vilnius, 09112, Lithuania|Forest Investigative Site 812, Trujillo, La Libertad, Peru|Forest Investigative Site 811, Chiclayo, Lambayeque, Peru|Forest Investigative Site 804, Arequipa, 804, Peru|Forest Investigative Site 803, Arequipa, Peru|Forest Investigative Site 805, Lima, Lima 14, Peru|Forest Investigative Site 813, Lima, Lima 17, Peru|Forest Investigative Site 801, Lima, Lima 27, Peru|Forest Investigative Site 807, Lima, Lima 27, Peru|Forest Investigative Site 809, Lima, Lima 33, Peru|Forest Investigative Site 808, Lima, Lima 41, Peru|Forest Investigative Site 802, Piura, Peru|Forest Investigative Site 909, Bacau, 600164, Romania|Forest Investigative Site 906, Bucuresti, 010584, Romania|Forest Investigative Site 908, Bucuresti, 020725, Romania|Forest Investigative Site 903, Satu Mare, 440055, Romania|Forest Investigative Site 901, Sibiu, 550245, Romania|Forest Investigative Site 905, Tg Mures, 540142, Romania|Forest Investigative Site 902, Timisoara, 300736, Romania
URL: https://clinicaltrials.gov/show/NCT00947557

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress