Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
27 maart 2018 bijgewerkt door: Elcelyx Therapeutics, Inc.
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
The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks.
The study is designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning [qAM]) compared to placebo.
A single-blind reference treatment of 2000 mg metformin immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID) will also be included.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
571
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Carolina, Puerto Rico, 00987
- Puerto Rico Renal and Health Research, Inc.
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Cidra, Puerto Rico, 00736
- Advanced Medical Concepts
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Manati, Puerto Rico, 00674
- Manati Center for Clinical Reserach Doctor's Center Hospital
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Alabama
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Anniston, Alabama, Verenigde Staten, 36207
- Pinnacle Research Group, LLC
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Birmingham, Alabama, Verenigde Staten, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Verenigde Staten, 35216
- Achieve Clinical Research, LLC
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Birmingham, Alabama, Verenigde Staten, 35209
- Central Alabama Research
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Tuscumbia, Alabama, Verenigde Staten, 35674
- Terence T. Hart, MD
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Arizona
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Chandler, Arizona, Verenigde Staten, 85224
- Radiant Research - Phoenix
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Glendale, Arizona, Verenigde Staten, 85306
- Arrowhead Health Centers
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Peoria, Arizona, Verenigde Staten, 85381
- Holland Center for Family Health, LTD
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Phoenix, Arizona, Verenigde Staten, 85018
- Elite Clinical Studies
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Phoenix, Arizona, Verenigde Staten, 85037
- Thunderbird Internal Medicine - Indian School Rd.
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Surprise, Arizona, Verenigde Staten, 85374
- Clinical Research Institute of Arizona, LLC
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Arkansas
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Fayetteville, Arkansas, Verenigde Staten, 72703
- Summit Clinical Trials Center
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Searcy, Arkansas, Verenigde Staten, 72143
- Searcy Medical Center
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California
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Escondido, California, Verenigde Staten, 92025
- Advanced Metabolic Care & Research Institute (AMCR)
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Fountain Valley, California, Verenigde Staten, 92708
- MD Studies, Inc.
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Huntington Park, California, Verenigde Staten, 90255
- National Research Institute
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La Jolla, California, Verenigde Staten, 92037
- Scripps Whittier Diabetes Institute
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Lincoln, California, Verenigde Staten, 95648
- Clinical Trials Research
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Long Beach, California, Verenigde Staten, 90806
- Collaborative Neuroscience Network, LLC
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Los Angeles, California, Verenigde Staten, 90057
- National Research Institute
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Montclair, California, Verenigde Staten, 91763
- Catalina Research Institute
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National City, California, Verenigde Staten, 91950
- SRSD, Inc. dba Synergy San Diego
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North Hollywood, California, Verenigde Staten, 91606
- Providence Clinical Research
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Oakland, California, Verenigde Staten, 94607
- Pacific Research Partners, LLC
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Orange, California, Verenigde Staten, 92868
- SDS Clinical Trials, Inc.
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Sacramento, California, Verenigde Staten, 95825
- Superior Research LLC
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Sacramento, California, Verenigde Staten, 95823
- Center for Clinical Trials of Sacramento
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Sacramento, California, Verenigde Staten, 95823
- Center for Clinical Trials of Scaramento
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Santa Ana, California, Verenigde Staten, 92705
- Syrentis Clinical Research (formerly Research Across America)
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Spring Valley, California, Verenigde Staten, 91978
- Encompass Clinical Research
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Tustin, California, Verenigde Staten, 92780
- Clinical Trial Investigators
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Van Nuys, California, Verenigde Staten, 91405
- Infosphere Clinical Research
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80906
- Colorado Springs Health Partners
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Denver, Colorado, Verenigde Staten, 80209
- Creekside Endocrine Associates
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Florida
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Brooksville, Florida, Verenigde Staten, 34601
- Meridien Research - Brooksville
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Cooper City, Florida, Verenigde Staten, 33024
- ALL Medical Research, LLC
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Hialeah, Florida, Verenigde Staten, 33012
- Neostart Corporation dba AGA Clinical Trials
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Jacksonville, Florida, Verenigde Staten, 32277
- Care Partners Clinical Research
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Jupiter, Florida, Verenigde Staten, 33458
- Health Awareness, Inc.
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Kissimmee, Florida, Verenigde Staten, 34741
- Family Health Care Clinical Studies
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Lakeland, Florida, Verenigde Staten, 33810
- Clinical Research of Central Florida-Lakeland
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Miami, Florida, Verenigde Staten, 33014
- Clinical Pharmacology of Miami, Inc.
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Miami, Florida, Verenigde Staten, 33173
- Tellus Clinical Research, Inc.
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Miami, Florida, Verenigde Staten, 33183
- Internal Research Associates LLC - Breton
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Orlando, Florida, Verenigde Staten, 32801
- Clinical Neuroscience Solutions, Inc. Healthcare Orlando
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Ormond Beach, Florida, Verenigde Staten, 32174
- Ormond Medical Arts Pharmaceutical Research Center
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Pembroke Pines, Florida, Verenigde Staten, 33026
- Private Practice - Andres Patron, DO
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Port Orange, Florida, Verenigde Staten, 32127
- Progressive Medical Research
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Saint Petersburg, Florida, Verenigde Staten, 33709
- Meridien Reserach - St. Petersburg
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Tampa, Florida, Verenigde Staten, 33634
- Meridien Research - Tampa
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Tampa, Florida, Verenigde Staten, 33607
- Clinical Reserch Trials of Florida
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West Palm Beach, Florida, Verenigde Staten, 33401
- Metabolic Research Institute, Inc.
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Illinois
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Addison, Illinois, Verenigde Staten, 60101
- Biofortis, Inc.
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Aurora, Illinois, Verenigde Staten, 60506
- AMR Sakeena Research
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Chicago, Illinois, Verenigde Staten, 60607
- Cedar-Crosse Research Center
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Evanston, Illinois, Verenigde Staten, 60201
- Evanston Premier Healthcare Research LLC
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Indiana
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Valparaiso, Indiana, Verenigde Staten, 46383
- Buynak Clinical Research, PC
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Iowa
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West Des Moines, Iowa, Verenigde Staten, 50266
- The Iowa Clinic; Cardiovascular Services
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Kansas
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Augusta, Kansas, Verenigde Staten, 67010
- Heartland Research Associates, LLC - Augusta
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Topeka, Kansas, Verenigde Staten, 66606
- Cotton-O'Neil Clinical Research Center
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Kentucky
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Edgewood, Kentucky, Verenigde Staten, 41017
- Otrimed
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Lexington, Kentucky, Verenigde Staten, 40503
- Kentucky Diabetes Endocrinology Center
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Louisville, Kentucky, Verenigde Staten, 40213
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
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Paducah, Kentucky, Verenigde Staten, 42003
- Four Rivers Clinical Research
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Louisiana
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Crowley, Louisiana, Verenigde Staten, 70526
- Avant Research Associates
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Lake Charles, Louisiana, Verenigde Staten, 70601
- Centex Studies, Inc. - Lake Charles
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Maryland
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Columbia, Maryland, Verenigde Staten, 21045
- Columbia Medical Practice
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Hyattsville, Maryland, Verenigde Staten, 20782
- Medstar Health Research Institute
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Oxon Hill, Maryland, Verenigde Staten, 20745
- MD Medical Research
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Massachusetts
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Quincy, Massachusetts, Verenigde Staten, 02169
- Beacon Clinical Research
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Minnesota
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Edina, Minnesota, Verenigde Staten, 55435
- Radiant Research - Edina
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Mississippi
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Port Gibson, Mississippi, Verenigde Staten, 39150
- Planters Clinic
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Montana
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Butte, Montana, Verenigde Staten, 59701
- Mercury Street Medical Group, PLLC
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68114
- Quality Clinical Research, Inc.
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Omaha, Nebraska, Verenigde Staten, 68134
- Heartland Clinical Research
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89119
- AB Clinical Trials
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Las Vegas, Nevada, Verenigde Staten, 89101
- Alliance Against Diabetes
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Las Vegas, Nevada, Verenigde Staten, 89128
- Palm Medical Research
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Las Vegas, Nevada, Verenigde Staten, 89146
- Ingham Neuroscience Group, LLC
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New Jersey
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Berlin, New Jersey, Verenigde Staten, 08009
- Comprehensive Clinical Research
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87109
- Albuquerque Neuroscience, Inc.
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Albuquerque, New Mexico, Verenigde Staten, 87102
- Albuquerque Clinical Trials
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New York
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Brooklyn, New York, Verenigde Staten, 11235
- NY Scientific
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Great Neck, New York, Verenigde Staten, 11023
- Long Island Gastrointestinal Research Group
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Hopewell Junction, New York, Verenigde Staten, 12533
- Mid-Hudson Medical Research, PLLC
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Westfield, New York, Verenigde Staten, 14787
- Great Lakes Medical Research
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North Carolina
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Greensboro, North Carolina, Verenigde Staten, 27408
- PharmQuest
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Greensboro, North Carolina, Verenigde Staten, 27410
- Triad Clinical Trials LLC
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Rocky Mount, North Carolina, Verenigde Staten, 27804
- PMG Research of Rocky Mount
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Salisbury, North Carolina, Verenigde Staten, 28144
- PMG Research of Salisbury, LLC
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Wilmington, North Carolina, Verenigde Staten, 28401
- PMG Research of Wilmington, LLC
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45242
- New Horizons Clinical Research
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Cincinnati, Ohio, Verenigde Staten, 45219
- Sterling Research Group, Ltd
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Cincinnati, Ohio, Verenigde Staten, 45227
- Metabolic Atherosclerosis Research Center
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Columbus, Ohio, Verenigde Staten, 43214
- Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health
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Franklin, Ohio, Verenigde Staten, 45005
- Prestige Clinical Research
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Huber Heights, Ohio, Verenigde Staten, 45424
- Hometown Urgent Care and Research - Huber Heights
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Marion, Ohio, Verenigde Staten, 43302
- RAS Health LTD
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Stow, Ohio, Verenigde Staten, 44224
- Summit Reserach Group, LLC
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73103
- COR Clinical Research, LLC
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Oregon
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Eugene, Oregon, Verenigde Staten, 97404
- Willamette Valley Clinical Studies
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Pennsylvania
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Downingtown, Pennsylvania, Verenigde Staten, 19335
- Brandywine Clinical Research
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29407
- Medical Research South, LLC
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Greer, South Carolina, Verenigde Staten, 29651
- Mountain View CLinical Research - Greer
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Mount Pleasant, South Carolina, Verenigde Staten, 29464
- PMG of Charleston, LLC
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Myrtle Beach, South Carolina, Verenigde Staten, 29588
- Family Medicine of SayeBrook, LLC
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Simpsonville, South Carolina, Verenigde Staten, 29681
- Hillcrest Clinical Research, LLC
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Spartanburg, South Carolina, Verenigde Staten, 29303
- Spartanburg Medical Research
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Spartanburg, South Carolina, Verenigde Staten, 29301
- Palmetto Proactive Healthcare, LLC
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Summerville, South Carolina, Verenigde Staten, 29485
- Palmetto Clinical Research
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Tennessee
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Bristol, Tennessee, Verenigde Staten, 37620
- PMG Research of Bristol, LC - State
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Knoxville, Tennessee, Verenigde Staten, 37912
- PMG Research of Knoxville
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Memphis, Tennessee, Verenigde Staten, 38119
- Clinical Neuroscience Solutions, Inc. - Memphis
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Tullahoma, Tennessee, Verenigde Staten, 37388
- Trinity Clinical Research
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Texas
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Austin, Texas, Verenigde Staten, 78705
- Central Texas Clinical Research
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Carrollton, Texas, Verenigde Staten, 75007
- Trinity Universal Research Associates, Inc.
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Dallas, Texas, Verenigde Staten, 75230
- Dallas Diabetes and Endocrine Center
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Dallas, Texas, Verenigde Staten, 75231
- Research Institute of Dallas
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Dallas, Texas, Verenigde Staten, 75251
- Galenos Research
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Houston, Texas, Verenigde Staten, 77058
- Centex Studies, Inc.
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Houston, Texas, Verenigde Staten, 77036
- Pioneer Research Solutions, Inc.
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Houston, Texas, Verenigde Staten, 77074
- Clinical Trial Network - Houston
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Houston, Texas, Verenigde Staten, 77074
- Juno Research, LLC-Houston
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Katy, Texas, Verenigde Staten, 77450
- Juno Research, LLC-Katy
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San Antonio, Texas, Verenigde Staten, 78215
- Sun Research Institute
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San Antonio, Texas, Verenigde Staten, 78231
- Victorium Clinical Research
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San Antonio, Texas, Verenigde Staten, 78207
- Texas Diabetes Institute Research Center
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Shavano Park, Texas, Verenigde Staten, 78231
- Consano Clinical Research
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Sugar Land, Texas, Verenigde Staten, 77478
- Southwest Health Associates, P.A.
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Utah
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Saint George, Utah, Verenigde Staten, 84790
- Chrysalis Clinical Research
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Virginia
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Burke, Virginia, Verenigde Staten, 22015
- Burke Internal Medicine & Research
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Manassas, Virginia, Verenigde Staten, 20110
- Manassas Clinical Research Center
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Richmond, Virginia, Verenigde Staten, 23235
- Clinical Research Partners, LLC
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Washington
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Tacoma, Washington, Verenigde Staten, 98405
- Universal Research Group, LLC
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
25 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
|
metformine tabletten met vertraagde afgifte
|
|
Experimenteel: 900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
|
metformine tabletten met vertraagde afgifte
|
|
Experimenteel: 1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
|
metformine tabletten met vertraagde afgifte
|
|
Experimenteel: 1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
|
metformine tabletten met vertraagde afgifte
|
|
Placebo-vergelijker: Placebo-1
placebo match for 600 and 1200 mg Met DR qAM treatment groups
|
|
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Placebo-vergelijker: Placebo-2
placebo match for 900 and 1500 mg Met DR qAM treatment groups
|
|
|
Actieve vergelijker: 2000 mg Met IR
1000 mg metformin immediate-release twice daily
|
metformin immediate-release tablets
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in HbA1c (%) at 16 Weeks
Tijdsspanne: Baseline and 16 weeks after the first dose of study medication
|
Baseline and 16 weeks after the first dose of study medication
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Juan P Frias, MD, National Research Institute - Wilshire
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2015
Primaire voltooiing (Werkelijk)
1 september 2016
Studie voltooiing (Werkelijk)
1 september 2016
Studieregistratiedata
Eerst ingediend
16 augustus 2015
Eerst ingediend dat voldeed aan de QC-criteria
17 augustus 2015
Eerst geplaatst (Schatting)
18 augustus 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 april 2018
Laatste update ingediend die voldeed aan QC-criteria
27 maart 2018
Laatst geverifieerd
1 maart 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- LCRM112
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .