- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02526524
Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled, Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release In Subjects With Type 2 Diabetes Mellitus
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Alabama
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Anniston, Alabama, Estados Unidos, 36207
- Pinnacle Research Group, LLC
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Estados Unidos, 35216
- Achieve Clinical Research, LLC
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Birmingham, Alabama, Estados Unidos, 35209
- Central Alabama Research
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Tuscumbia, Alabama, Estados Unidos, 35674
- Terence T. Hart, MD
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Arizona
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Chandler, Arizona, Estados Unidos, 85224
- Radiant Research - Phoenix
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Glendale, Arizona, Estados Unidos, 85306
- Arrowhead Health Centers
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Peoria, Arizona, Estados Unidos, 85381
- Holland Center for Family Health, LTD
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Phoenix, Arizona, Estados Unidos, 85018
- Elite Clinical Studies
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Phoenix, Arizona, Estados Unidos, 85037
- Thunderbird Internal Medicine - Indian School Rd.
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Surprise, Arizona, Estados Unidos, 85374
- Clinical Research Institute of Arizona, LLC
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Arkansas
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Fayetteville, Arkansas, Estados Unidos, 72703
- Summit Clinical Trials Center
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Searcy, Arkansas, Estados Unidos, 72143
- Searcy Medical Center
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California
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Escondido, California, Estados Unidos, 92025
- Advanced Metabolic Care & Research Institute (AMCR)
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Fountain Valley, California, Estados Unidos, 92708
- MD Studies, Inc.
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Huntington Park, California, Estados Unidos, 90255
- National Research Institute
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La Jolla, California, Estados Unidos, 92037
- Scripps Whittier Diabetes Institute
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Lincoln, California, Estados Unidos, 95648
- Clinical Trials Research
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Long Beach, California, Estados Unidos, 90806
- Collaborative Neuroscience Network, LLC
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Los Angeles, California, Estados Unidos, 90057
- National Research Institute
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Montclair, California, Estados Unidos, 91763
- Catalina Research Institute
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National City, California, Estados Unidos, 91950
- SRSD, Inc. dba Synergy San Diego
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North Hollywood, California, Estados Unidos, 91606
- Providence Clinical Research
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Oakland, California, Estados Unidos, 94607
- Pacific Research Partners, LLC
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Orange, California, Estados Unidos, 92868
- SDS Clinical Trials, Inc.
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Sacramento, California, Estados Unidos, 95825
- Superior Research LLC
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Sacramento, California, Estados Unidos, 95823
- Center for Clinical Trials of Sacramento
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Sacramento, California, Estados Unidos, 95823
- Center for Clinical Trials of Scaramento
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Santa Ana, California, Estados Unidos, 92705
- Syrentis Clinical Research (formerly Research Across America)
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Spring Valley, California, Estados Unidos, 91978
- Encompass Clinical Research
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Tustin, California, Estados Unidos, 92780
- Clinical Trial Investigators
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Van Nuys, California, Estados Unidos, 91405
- Infosphere Clinical Research
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80906
- Colorado Springs Health Partners
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Denver, Colorado, Estados Unidos, 80209
- Creekside Endocrine Associates
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Florida
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Brooksville, Florida, Estados Unidos, 34601
- Meridien Research - Brooksville
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Cooper City, Florida, Estados Unidos, 33024
- ALL Medical Research, LLC
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Hialeah, Florida, Estados Unidos, 33012
- Neostart Corporation dba AGA Clinical Trials
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Jacksonville, Florida, Estados Unidos, 32277
- Care Partners Clinical Research
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Jupiter, Florida, Estados Unidos, 33458
- Health Awareness, Inc.
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Kissimmee, Florida, Estados Unidos, 34741
- Family Health Care Clinical Studies
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Lakeland, Florida, Estados Unidos, 33810
- Clinical Research of Central Florida-Lakeland
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Miami, Florida, Estados Unidos, 33014
- Clinical Pharmacology of Miami, Inc.
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Miami, Florida, Estados Unidos, 33173
- Tellus Clinical Research, Inc.
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Miami, Florida, Estados Unidos, 33183
- Internal Research Associates LLC - Breton
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Orlando, Florida, Estados Unidos, 32801
- Clinical Neuroscience Solutions, Inc. Healthcare Orlando
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Ormond Beach, Florida, Estados Unidos, 32174
- Ormond Medical Arts Pharmaceutical Research Center
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Pembroke Pines, Florida, Estados Unidos, 33026
- Private Practice - Andres Patron, DO
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Port Orange, Florida, Estados Unidos, 32127
- Progressive Medical Research
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Saint Petersburg, Florida, Estados Unidos, 33709
- Meridien Reserach - St. Petersburg
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Tampa, Florida, Estados Unidos, 33634
- Meridien Research - Tampa
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Tampa, Florida, Estados Unidos, 33607
- Clinical Reserch Trials of Florida
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West Palm Beach, Florida, Estados Unidos, 33401
- Metabolic Research Institute, Inc.
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Illinois
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Addison, Illinois, Estados Unidos, 60101
- Biofortis, Inc.
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Aurora, Illinois, Estados Unidos, 60506
- AMR Sakeena Research
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Chicago, Illinois, Estados Unidos, 60607
- Cedar-Crosse Research Center
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Evanston, Illinois, Estados Unidos, 60201
- Evanston Premier Healthcare Research LLC
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Indiana
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Valparaiso, Indiana, Estados Unidos, 46383
- Buynak Clinical Research, PC
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Iowa
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West Des Moines, Iowa, Estados Unidos, 50266
- The Iowa Clinic; Cardiovascular Services
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Kansas
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Augusta, Kansas, Estados Unidos, 67010
- Heartland Research Associates, LLC - Augusta
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Topeka, Kansas, Estados Unidos, 66606
- Cotton-O'Neil Clinical Research Center
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Kentucky
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Edgewood, Kentucky, Estados Unidos, 41017
- Otrimed
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Lexington, Kentucky, Estados Unidos, 40503
- Kentucky Diabetes Endocrinology Center
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Louisville, Kentucky, Estados Unidos, 40213
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
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Paducah, Kentucky, Estados Unidos, 42003
- Four Rivers Clinical Research
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Louisiana
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Crowley, Louisiana, Estados Unidos, 70526
- Avant Research Associates
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Lake Charles, Louisiana, Estados Unidos, 70601
- Centex Studies, Inc. - Lake Charles
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Maryland
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Columbia, Maryland, Estados Unidos, 21045
- Columbia Medical Practice
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Hyattsville, Maryland, Estados Unidos, 20782
- MedStar Health Research Institute
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Oxon Hill, Maryland, Estados Unidos, 20745
- Md Medical Research
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Massachusetts
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Quincy, Massachusetts, Estados Unidos, 02169
- Beacon Clinical Research
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Minnesota
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Edina, Minnesota, Estados Unidos, 55435
- Radiant Research - Edina
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Mississippi
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Port Gibson, Mississippi, Estados Unidos, 39150
- Planters Clinic
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Montana
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Butte, Montana, Estados Unidos, 59701
- Mercury Street Medical Group, PLLC
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68114
- Quality Clinical Research, Inc.
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Omaha, Nebraska, Estados Unidos, 68134
- Heartland Clinical Research
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89119
- AB Clinical Trials
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Las Vegas, Nevada, Estados Unidos, 89101
- Alliance Against Diabetes
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Las Vegas, Nevada, Estados Unidos, 89128
- Palm Medical Research
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Las Vegas, Nevada, Estados Unidos, 89146
- Ingham Neuroscience Group, LLC
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New Jersey
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Berlin, New Jersey, Estados Unidos, 08009
- Comprehensive Clinical Research
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87109
- Albuquerque Neuroscience, Inc.
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Albuquerque, New Mexico, Estados Unidos, 87102
- Albuquerque Clinical Trials
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New York
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Brooklyn, New York, Estados Unidos, 11235
- NY Scientific
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Great Neck, New York, Estados Unidos, 11023
- Long Island Gastrointestinal Research Group
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Hopewell Junction, New York, Estados Unidos, 12533
- Mid-Hudson Medical Research, PLLC
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Westfield, New York, Estados Unidos, 14787
- Great Lakes Medical Research
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North Carolina
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Greensboro, North Carolina, Estados Unidos, 27408
- PharmQuest
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Greensboro, North Carolina, Estados Unidos, 27410
- Triad Clinical Trials LLC
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Rocky Mount, North Carolina, Estados Unidos, 27804
- PMG Research of Rocky Mount
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Salisbury, North Carolina, Estados Unidos, 28144
- PMG Research of Salisbury, LLC
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Wilmington, North Carolina, Estados Unidos, 28401
- PMG Research of Wilmington, LLC
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- New Horizons Clinical Research
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Cincinnati, Ohio, Estados Unidos, 45219
- Sterling Research Group, Ltd
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Cincinnati, Ohio, Estados Unidos, 45227
- Metabolic Atherosclerosis Research Center
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Columbus, Ohio, Estados Unidos, 43214
- Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health
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Franklin, Ohio, Estados Unidos, 45005
- Prestige Clinical Research
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Huber Heights, Ohio, Estados Unidos, 45424
- Hometown Urgent Care and Research - Huber Heights
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Marion, Ohio, Estados Unidos, 43302
- RAS Health LTD
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Stow, Ohio, Estados Unidos, 44224
- Summit Reserach Group, LLC
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73103
- COR Clinical Research, LLC
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Oregon
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Eugene, Oregon, Estados Unidos, 97404
- Willamette Valley Clinical Studies
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Pennsylvania
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Downingtown, Pennsylvania, Estados Unidos, 19335
- Brandywine Clinical Research
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29407
- Medical Research South, LLC
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Greer, South Carolina, Estados Unidos, 29651
- Mountain View Clinical Research - Greer
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Mount Pleasant, South Carolina, Estados Unidos, 29464
- PMG of Charleston, LLC
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Myrtle Beach, South Carolina, Estados Unidos, 29588
- Family Medicine of SayeBrook, LLC
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Simpsonville, South Carolina, Estados Unidos, 29681
- Hillcrest Clinical Research, LLC
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Spartanburg, South Carolina, Estados Unidos, 29303
- Spartanburg Medical Research
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Spartanburg, South Carolina, Estados Unidos, 29301
- Palmetto Proactive Healthcare, LLC
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Summerville, South Carolina, Estados Unidos, 29485
- Palmetto Clinical Research
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Tennessee
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Bristol, Tennessee, Estados Unidos, 37620
- PMG Research of Bristol, LC - State
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Knoxville, Tennessee, Estados Unidos, 37912
- PMG Research of Knoxville
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Memphis, Tennessee, Estados Unidos, 38119
- Clinical Neuroscience Solutions, Inc. - Memphis
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Tullahoma, Tennessee, Estados Unidos, 37388
- Trinity Clinical Research
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Texas
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Austin, Texas, Estados Unidos, 78705
- Central Texas Clinical Research
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Carrollton, Texas, Estados Unidos, 75007
- Trinity Universal Research Associates, Inc.
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Dallas, Texas, Estados Unidos, 75230
- Dallas Diabetes and Endocrine Center
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Dallas, Texas, Estados Unidos, 75231
- Research Institute Of Dallas
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Dallas, Texas, Estados Unidos, 75251
- Galenos Research
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Houston, Texas, Estados Unidos, 77058
- Centex Studies, Inc.
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Houston, Texas, Estados Unidos, 77036
- Pioneer Research Solutions, Inc.
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Houston, Texas, Estados Unidos, 77074
- Clinical Trial Network - Houston
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Houston, Texas, Estados Unidos, 77074
- Juno Research, LLC-Houston
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Katy, Texas, Estados Unidos, 77450
- Juno Research, LLC-Katy
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San Antonio, Texas, Estados Unidos, 78215
- Sun Research Institute
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San Antonio, Texas, Estados Unidos, 78231
- Victorium Clinical Research
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San Antonio, Texas, Estados Unidos, 78207
- Texas Diabetes Institute Research Center
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Shavano Park, Texas, Estados Unidos, 78231
- Consano Clinical Research
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Sugar Land, Texas, Estados Unidos, 77478
- Southwest Health Associates, P.A.
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Utah
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Saint George, Utah, Estados Unidos, 84790
- Chrysalis Clinical Research
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Virginia
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Burke, Virginia, Estados Unidos, 22015
- Burke Internal Medicine & Research
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Manassas, Virginia, Estados Unidos, 20110
- Manassas Clinical Research Center
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Richmond, Virginia, Estados Unidos, 23235
- Clinical Research Partners, LLC
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Washington
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Tacoma, Washington, Estados Unidos, 98405
- Universal Research Group, LLC
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Carolina, Porto Rico, 00987
- Puerto Rico Renal and Health Research, Inc.
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Cidra, Porto Rico, 00736
- Advanced Medical Concepts
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Manati, Porto Rico, 00674
- Manati Center for Clinical Reserach Doctor's Center Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Is at least 25 years old at Visit 1 (Screening).
Is male, or is female and meets all of the following criteria:
- Not breastfeeding
- Negative pregnancy test result at Visit 1 (not applicable to post-menopausal or surgically sterile females)
- Surgically sterile, postmenopausal, or if of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study.
- Body mass index (BMI) 20.0 to 45.0 kg/m² (inclusive) at Visit 1 (Screening).
- Has a physical examination with no clinically significant abnormalities as judged by the investigator.
- Has T2DM and an HbA1c of 7.5% to 10.5%, inclusive, at Visit 1.
- Has an estimated glomerular filtration rate (eGFR) value of ≥60 mL/min/1.73 m² based on the Modification of Diet in Renal Disease (MDRD) equation.
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 3 months prior to Visit 1:
- Thiazolidinedione, sulfonylurea, dipeptidyl peptidase-4 inhibitors, and alpha-glucosidase inhibitors
- Hormone replacement therapy (female subjects) and testosterone (male subjects)
- Oral contraceptives (female subjects)
- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy
- Antidepressant agents
- Ability to understand and willingness to adhere to protocol requirements.
Exclusion Criteria:
Has a clinically significant medical condition as judged by the investigator that could potentially affect study participation and/or personal well-being, including but not limited to the following conditions:
- Hepatic disease
- Gastrointestinal disease
- Endocrine disorder (T2DM is allowed)
- Cardiovascular disease
- Central nervous system diseases
- Psychiatric or neurological disorders
- Organ transplantation
- Chronic or acute infection
- Orthostatic hypotension, fainting spells or blackouts
- Allergy or hypersensitivity.
- A history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within the past year.
- Prior major surgery of any kind within 6 months of Visit 1.
- A history of >3% weight change within 3 months of Visit 1.
- A clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormality, other than that related to T2DM, judged by the investigator to be clinically significant at Visit 1.
- An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN.
- A physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study.
Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications:
- Metformin within 2 months of Visit 1 (Screening)
- Insulin within 2 weeks of Visit 1 (Screening) or for more than 1 week within 3 months of Visit 1 (Screening)
- Glucagon-like peptide-1 receptor agonists or sodium-glucose co-transporter 2 inhibitors within 3 months of Visit 1
- Drugs known to affect body weight, including prescription medications and over-the-counter anti obesity agents within 3 months of Visit 1.
- Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of Visit 1
- Planned use of any drug treatment that affects gastric pH (prescription or over-the-counter), such as H2-receptor antagonists and proton pump inhibitors, after Visit 2 (Week -2), or planned chronic use of any antacids (i.e., more than twice per week) after Visit 2 (Week -2)
- Cationic drugs that are eliminated by renal tubular secretion within 1 week of Visit 1.
- Iodinated contrast dye within 1 week prior to Visit 1.
- Investigational drug within 2 months (or five half-lives of the investigational drug, whichever is greater) of the date of the first dose of randomized study medication.
- Met DR or double-blind matching placebo for Met DR at any time prior to Visit 1 (Screening)
- Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures.
- Had a blood transfusion or experienced significant blood loss (i.e., >500 mL), including loss due to blood donation, within 2 months prior to Visit 1 (Screening), or is planning to donate blood during the study.
- Has known immune system based allergies or hypersensitivity to any component of study treatment. A history of gastrointestinal intolerance to metformin is not exclusionary.
- Is employed by Elcelyx Therapeutics, Inc. (that is an employee, contract worker, or designee of the company).
- Has a fasting plasma glucose value >270 mg/dL at Visit 1 (Screening), Visit 2 (Week -2), and an unscheduled visit to be completed within 1 week following Visit 2. The unscheduled visit is to be completed only for subjects with a fasting plasma glucose value >270 mg/dL at Visit 1 and Visit 2.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
|
metformina comprimidos de liberação retardada
|
Experimental: 900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
|
metformina comprimidos de liberação retardada
|
Experimental: 1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
|
metformina comprimidos de liberação retardada
|
Experimental: 1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
|
metformina comprimidos de liberação retardada
|
Comparador de Placebo: Placebo-1
placebo match for 600 and 1200 mg Met DR qAM treatment groups
|
|
Comparador de Placebo: Placebo-2
placebo match for 900 and 1500 mg Met DR qAM treatment groups
|
|
Comparador Ativo: 2000 mg Met IR
1000 mg metformin immediate-release twice daily
|
metformin immediate-release tablets
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Change in HbA1c (%) at 16 Weeks
Prazo: Baseline and 16 weeks after the first dose of study medication
|
Baseline and 16 weeks after the first dose of study medication
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Juan P Frias, MD, National Research Institute - Wilshire
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LCRM112
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