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Clinical Trial Details

Trial ID: L6259
Source ID: NCT00631007
Associated Drug: Int131 Besylate
Title: A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00631007/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: INT131 besylate|DRUG: Pioglitazone HCl|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward, HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent, Weeks 0-24 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward., The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward., Weeks 0-24
Sponsor/Collaborators: Sponsor: InteKrin Therapeutics, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 367
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-02
Completion Date: 2009-09
Results First Posted: 2010-09-13
Last Update Posted: 2010-09-13
Locations: Northern California Research, Carmichael, California, 95608, United States|National Research Institute, Los Angeles, California, 90057, United States|VA San Diego Healthcare System, San Diego, California, 92161, United States|Apex Research Institute, Santa Ana, California, 92705, United States|Internal Medicine of the Rockies, Colorado Springs, Colorado, 80910, United States|Creekside Endocrine Associates, PC, Denver, Colorado, 80209, United States|Clinical Research Consulting, LLC, Milford, Connecticut, 06460, United States|MedStar Research Institute, Washington, District of Columbia, 20003, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|The Center for Diabetes and Endocrine Care, Hollywood, Florida, 33021, United States|Baptist Diabetes Associates, PA, Miami, Florida, 33156, United States|International Research Associates, LLC, Miami, Florida, 33156, United States|Elite Research Institute, Miami, Florida, 33169, United States|Suncoast Clinical Research, Inc., New Port Richey, Florida, 34652, United States|Suncoast Clinical Research, Inc., Palm Harbor, Florida, 34652, United States|Meridien Research, Tampa, Florida, 33606, United States|Meridien Research, Tampa, Florida, 34203, United States|Clinical Research of Central Florida, Winter Haven, Florida, 33880, United States|Executive Health and Research Associates, Inc., Atlanta, Georgia, 30342, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|ICCT Reseach International, Chicago, Illinois, 60611, United States|American Health Network, Indianapolis, Indiana, 46254, United States|L-Marc Research Center, Louisville, Kentucky, 40213, United States|New Orleans Center for Clinical Research, New Orleans, Louisiana, 70119, United States|Stephen R. Smith, MD, Baltimore, Maryland, 21234, United States|Olive Branch Family Medical Center, Olive Branch, Mississippi, 38654, United States|Diabetes and Endocrinology Specialists, Inc., Chesterfield, Missouri, 63017, United States|Saint Luke's Lipid and Diabetes Reseach Center, Kansas City, Missouri, 64111, United States|Bozeman Deaconess Internal Medicine Associates, Bozeman, Montana, 59715, United States|Comprehensive Clinical Research, Berlin, New Jersey, 08009, United States|Kaleida Health Diabetes Center, Buffalo, New York, 14209, United States|UNC Diabetes Care Center/Highgate Specialty Center, Durham, North Carolina, 27713, United States|Fairbrook Medical Clinic, Hickory, North Carolina, 28602, United States|Diabetes & Endrocrinology Consultants, Morehead City, North Carolina, 28557, United States|The Lindner Clinical Trial Center, Cincinnati, Ohio, 45219, United States|IVA Research, Cincinnati, Ohio, 45245, United States|Rapid Medical Research, Inc, Cleveland, Ohio, 44122, United States|Opitmed Research, LTD, Columbus, Ohio, 43235, United States|ResEvo LLC, Cuyahoga Falls, Ohio, 44223, United States|Delaware Smith Clinic, Delaware, Ohio, 43015, United States|Prestige Clinical Research, Franklin, Ohio, 45005, United States|Wells Institute for Health Awareness, Kettering, Ohio, 45429, United States|Frederick C Smith Clinic, Marion, Ohio, 43302, United States|Your Diabetes Endocrine Nutrition Group, LLC, Mentor, Ohio, 44060, United States|Clinical Research Source, Inc, Perrysburg, Ohio, 43551, United States|Tri-State Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Lycoming Internal Medicine, Inc., Jersey Shore, Pennsylvania, 17740, United States|New England Center for Clinical Research, Cranston, Rhode Island, 02920, United States|Hartwell Research Group, Anderson, South Carolina, 29621, United States|Medical Research South, Charleston, South Carolina, 29407, United States|Palmetto Clinical Trial Services, LLC, Simpsonville, South Carolina, 29681, United States|Dallas Diabetes and Endocrine Research Center, Dallas, Texas, 75230, United States|Research Institute of Dallas, Dallas, Texas, 75231, United States|Baylor University Endocrine Center, Dallas, Texas, 75246, United States|Diabetes Center of the Southwest, Midland, Texas, 79705, United States|Quality Research, Inc., San Antonio, Texas, 78209, United States|DGD Research, San Antonio, Texas, 78229, United States|Salem VA Medical Center R&D Office, Salem, Virginia, 24153, United States|Nucleo Medico Vallarta, Guadalajara, Jalisco, Mexico|Comite Mexicano para la Prevencion de la Osteoporosis A.C., Mexico City, Mexico DF, 06100, Mexico|Centro Especializado en Diabetes y Obisidad (EDOPEC), Mexico City, Mexico DF, 11650, Mexico|Instituto Nacional de Nutricion Salvador Zubiran (INNSZ), Mexico City, Mexico DF, 14000, Mexico|Instituto Mexicano de Investigacion Clinica, Mexico City, Mexico DF, Mexico|Unidad Metabolica y Cardiovascular SC, Cuernavaca, Morelos, Mexico|Hospital Santa Engracia, Monterrey, Nuevo Leon, 66220, Mexico
URL: https://clinicaltrials.gov/show/NCT00631007

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress