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Clinical Trial Details

Trial ID: L4154
Source ID: NCT02526524
Associated Drug: Met Dr
Title: Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02526524/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Met DR|DRUG: Met IR|DRUG: Placebo
Outcome Measures: Primary: Change in HbA1c (%) at 16 Weeks, Baseline and 16 weeks after the first dose of study medication |
Sponsor/Collaborators: Sponsor: Elcelyx Therapeutics, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 571
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-09
Completion Date: 2016-09
Results First Posted: 2018-04-27
Last Update Posted: 2018-04-27
Locations: Pinnacle Research Group, LLC, Anniston, Alabama, 36207, United States|Central Alabama Research, Birmingham, Alabama, 35209, United States|Achieve Clinical Research, LLC, Birmingham, Alabama, 35216, United States|University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|Terence T. Hart, MD, Tuscumbia, Alabama, 35674, United States|Radiant Research - Phoenix, Chandler, Arizona, 85224, United States|Arrowhead Health Centers, Glendale, Arizona, 85306, United States|Holland Center for Family Health, LTD, Peoria, Arizona, 85381, United States|Elite Clinical Studies, Phoenix, Arizona, 85018, United States|Thunderbird Internal Medicine - Indian School Rd., Phoenix, Arizona, 85037, United States|Clinical Research Institute of Arizona, LLC, Surprise, Arizona, 85374, United States|Summit Clinical Trials Center, Fayetteville, Arkansas, 72703, United States|Searcy Medical Center, Searcy, Arkansas, 72143, United States|Advanced Metabolic Care & Research Institute (AMCR), Escondido, California, 92025, United States|MD Studies, Inc., Fountain Valley, California, 92708, United States|National Research Institute, Huntington Park, California, 90255, United States|Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States|Clinical Trials Research, Lincoln, California, 95648, United States|Collaborative Neuroscience Network, LLC, Long Beach, California, 90806, United States|National Research Institute, Los Angeles, California, 90057, United States|Catalina Research Institute, Montclair, California, 91763, United States|SRSD, Inc. dba Synergy San Diego, National City, California, 91950, United States|Providence Clinical Research, North Hollywood, California, 91606, United States|Pacific Research Partners, LLC, Oakland, California, 94607, United States|SDS Clinical Trials, Inc., Orange, California, 92868, United States|Center for Clinical Trials of Sacramento, Sacramento, California, 95823, United States|Center for Clinical Trials of Scaramento, Sacramento, California, 95823, United States|Superior Research LLC, Sacramento, California, 95825, United States|Syrentis Clinical Research (formerly Research Across America), Santa Ana, California, 92705, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Clinical Trial Investigators, Tustin, California, 92780, United States|Infosphere Clinical Research, Van Nuys, California, 91405, United States|Colorado Springs Health Partners, Colorado Springs, Colorado, 80906, United States|Creekside Endocrine Associates, Denver, Colorado, 80209, United States|Meridien Research - Brooksville, Brooksville, Florida, 34601, United States|ALL Medical Research, LLC, Cooper City, Florida, 33024, United States|Neostart Corporation dba AGA Clinical Trials, Hialeah, Florida, 33012, United States|Care Partners Clinical Research, Jacksonville, Florida, 32277, United States|Health Awareness, Inc., Jupiter, Florida, 33458, United States|Family Health Care Clinical Studies, Kissimmee, Florida, 34741, United States|Clinical Research of Central Florida-Lakeland, Lakeland, Florida, 33810, United States|Clinical Pharmacology of Miami, Inc., Miami, Florida, 33014, United States|Tellus Clinical Research, Inc., Miami, Florida, 33173, United States|Internal Research Associates LLC - Breton, Miami, Florida, 33183, United States|Clinical Neuroscience Solutions, Inc. Healthcare Orlando, Orlando, Florida, 32801, United States|Ormond Medical Arts Pharmaceutical Research Center, Ormond Beach, Florida, 32174, United States|Private Practice - Andres Patron, DO, Pembroke Pines, Florida, 33026, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Meridien Reserach - St. Petersburg, Saint Petersburg, Florida, 33709, United States|Clinical Reserch Trials of Florida, Tampa, Florida, 33607, United States|Meridien Research - Tampa, Tampa, Florida, 33634, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States|Biofortis, Inc., Addison, Illinois, 60101, United States|AMR Sakeena Research, Aurora, Illinois, 60506, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Evanston Premier Healthcare Research LLC, Evanston, Illinois, 60201, United States|Buynak Clinical Research, PC, Valparaiso, Indiana, 46383, United States|The Iowa Clinic; Cardiovascular Services, West Des Moines, Iowa, 50266, United States|Heartland Research Associates, LLC - Augusta, Augusta, Kansas, 67010, United States|Cotton-O'Neil Clinical Research Center, Topeka, Kansas, 66606, United States|Otrimed, Edgewood, Kentucky, 41017, United States|Kentucky Diabetes Endocrinology Center, Lexington, Kentucky, 40503, United States|Louisville Metabolic and Atherosclerosis Research Center (L-MARC), Louisville, Kentucky, 40213, United States|Four Rivers Clinical Research, Paducah, Kentucky, 42003, United States|Avant Research Associates, Crowley, Louisiana, 70526, United States|Centex Studies, Inc. - lake Charles, Lake Charles, Louisiana, 70601, United States|Columbia Medical Practice, Columbia, Maryland, 21045, United States|Medstar Health Research Institute, Hyattsville, Maryland, 20782, United States|MD Medical Research, Oxon Hill, Maryland, 20745, United States|Beacon Clinical Research, Quincy, Massachusetts, 02169, United States|Radiant Research - Edina, Edina, Minnesota, 55435, United States|Planters Clinic, Port Gibson, Mississippi, 39150, United States|Mercury Street Medical Group, PLLC, Butte, Montana, 59701, United States|Quality Clinical Research, Inc., Omaha, Nebraska, 68114, United States|Heartland Clinical Research, Omaha, Nebraska, 68134, United States|Alliance Against Diabetes, Las Vegas, Nevada, 89101, United States|AB Clinical Trials, Las Vegas, Nevada, 89119, United States|Palm Medical Research, Las Vegas, Nevada, 89128, United States|Ingham Neuroscience Group, LLC, Las Vegas, Nevada, 89146, United States|Comprehensive Clinical Research, Berlin, New Jersey, 08009, United States|Albuquerque Clinical Trials, Albuquerque, New Mexico, 87102, United States|Albuquerque Neuroscience, Inc., Albuquerque, New Mexico, 87109, United States|NY Scientific, Brooklyn, New York, 11235, United States|Long Island Gastrointestinal Research Group, Great Neck, New York, 11023, United States|Mid-Hudson Medical Research, PLLC, Hopewell Junction, New York, 12533, United States|Great Lakes Medical Research, Westfield, New York, 14787, United States|PharmQuest, Greensboro, North Carolina, 27408, United States|Triad Clinical Trials LLC, Greensboro, North Carolina, 27410, United States|PMG Research of Rocky Mount, Rocky Mount, North Carolina, 27804, United States|PMG Research of Salisbury, LLC, Salisbury, North Carolina, 28144, United States|PMG Research of Wilmington, LLC, Wilmington, North Carolina, 28401, United States|Sterling Research Group, Ltd, Cincinnati, Ohio, 45219, United States|Metabolic Atherosclerosis Research Center, Cincinnati, Ohio, 45227, United States|New Horizons Clinical Research, Cincinnati, Ohio, 45242, United States|Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health, Columbus, Ohio, 43214, United States|Prestige Clinical Research, Franklin, Ohio, 45005, United States|Hometown Urgent Care and Research - Huber Heights, Huber Heights, Ohio, 45424, United States|RAS Health LTD, Marion, Ohio, 43302, United States|Summit Reserach Group, LLC, Stow, Ohio, 44224, United States|COR Clinical Research, LLC, Oklahoma City, Oklahoma, 73103, United States|Willamette Valley Clinical Studies, Eugene, Oregon, 97404, United States|Brandywine Clinical Research, Downingtown, Pennsylvania, 19335, United States|Medical Research South, LLC, Charleston, South Carolina, 29407, United States|Mountain View Clinical Research - Greer, Greer, South Carolina, 29651, United States|PMG of Charleston, LLC, Mount Pleasant, South Carolina, 29464, United States|Family Medicine of SayeBrook, LLC, Myrtle Beach, South Carolina, 29588, United States|Hillcrest Clinical Research, LLC, Simpsonville, South Carolina, 29681, United States|Palmetto Proactive Healthcare, LLC, Spartanburg, South Carolina, 29301, United States|Spartanburg Medical Research, Spartanburg, South Carolina, 29303, United States|Palmetto Clinical Research, Summerville, South Carolina, 29485, United States|PMG Research of Bristol, LC - State, Bristol, Tennessee, 37620, United States|PMG Research of Knoxville, Knoxville, Tennessee, 37912, United States|Clinical Neuroscience Solutions, Inc. - Memphis, Memphis, Tennessee, 38119, United States|Trinity Clinical Research, Tullahoma, Tennessee, 37388, United States|Central Texas Clinical Research, Austin, Texas, 78705, United States|Trinity Universal Research Associates, Inc., Carrollton, Texas, 75007, United States|Dallas Diabetes and Endocrine Center, Dallas, Texas, 75230, United States|Research Institute of Dallas, Dallas, Texas, 75231, United States|Galenos Research, Dallas, Texas, 75251, United States|Pioneer Research Solutions, Inc., Houston, Texas, 77036, United States|Centex Studies, Inc., Houston, Texas, 77058, United States|Clinical Trial Network - Houston, Houston, Texas, 77074, United States|Juno Research, LLC-Houston, Houston, Texas, 77074, United States|Juno Research, LLC-Katy, Katy, Texas, 77450, United States|Texas Diabetes Institute Research Center, San Antonio, Texas, 78207, United States|Sun Research Institute, San Antonio, Texas, 78215, United States|Victorium Clinical Research, San Antonio, Texas, 78231, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States|Southwest Health Associates, P.A., Sugar Land, Texas, 77478, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|Burke Internal Medicine & Research, Burke, Virginia, 22015, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Clinical Research Partners, LLC, Richmond, Virginia, 23235, United States|Universal Research Group, LLC, Tacoma, Washington, 98405, United States|Puerto Rico Renal and Health Research, Inc., Carolina, 00987, Puerto Rico|Advanced Medical Concepts, Cidra, 00736, Puerto Rico|Manati Center for Clinical Reserach Doctor's Center Hospital, Manati, 00674, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT02526524