Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
27. mars 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
571
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Anniston, Alabama, Forente stater, 36207
- Pinnacle Research Group, Llc
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Birmingham, Alabama, Forente stater, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Forente stater, 35216
- Achieve Clinical Research, LLC
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Birmingham, Alabama, Forente stater, 35209
- Central Alabama Research
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Tuscumbia, Alabama, Forente stater, 35674
- Terence T. Hart, MD
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Arizona
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Chandler, Arizona, Forente stater, 85224
- Radiant Research - Phoenix
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Glendale, Arizona, Forente stater, 85306
- Arrowhead Health Centers
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Peoria, Arizona, Forente stater, 85381
- Holland Center for Family Health, LTD
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Phoenix, Arizona, Forente stater, 85018
- Elite Clinical Studies
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Phoenix, Arizona, Forente stater, 85037
- Thunderbird Internal Medicine - Indian School Rd.
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Surprise, Arizona, Forente stater, 85374
- Clinical Research Institute of Arizona, LLC
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Arkansas
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Fayetteville, Arkansas, Forente stater, 72703
- Summit Clinical Trials Center
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Searcy, Arkansas, Forente stater, 72143
- Searcy Medical Center
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California
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Escondido, California, Forente stater, 92025
- Advanced Metabolic Care & Research Institute (AMCR)
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Fountain Valley, California, Forente stater, 92708
- MD Studies, Inc.
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Huntington Park, California, Forente stater, 90255
- National Research Institute
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La Jolla, California, Forente stater, 92037
- Scripps Whittier Diabetes Institute
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Lincoln, California, Forente stater, 95648
- Clinical Trials Research
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Long Beach, California, Forente stater, 90806
- Collaborative Neuroscience Network, LLC
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Los Angeles, California, Forente stater, 90057
- National Research Institute
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Montclair, California, Forente stater, 91763
- Catalina Research Institute
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National City, California, Forente stater, 91950
- SRSD, Inc. dba Synergy San Diego
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North Hollywood, California, Forente stater, 91606
- Providence Clinical Research
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Oakland, California, Forente stater, 94607
- Pacific Research Partners, LLC
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Orange, California, Forente stater, 92868
- SDS Clinical Trials, Inc.
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Sacramento, California, Forente stater, 95825
- Superior Research LLC
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Sacramento, California, Forente stater, 95823
- Center for Clinical Trials of Sacramento
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Sacramento, California, Forente stater, 95823
- Center for Clinical Trials of Scaramento
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Santa Ana, California, Forente stater, 92705
- Syrentis Clinical Research (formerly Research Across America)
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Spring Valley, California, Forente stater, 91978
- Encompass Clinical Research
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Tustin, California, Forente stater, 92780
- Clinical Trial Investigators
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Van Nuys, California, Forente stater, 91405
- Infosphere Clinical Research
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Colorado
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Colorado Springs, Colorado, Forente stater, 80906
- Colorado Springs Health Partners
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Denver, Colorado, Forente stater, 80209
- Creekside Endocrine Associates
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Florida
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Brooksville, Florida, Forente stater, 34601
- Meridien Research - Brooksville
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Cooper City, Florida, Forente stater, 33024
- ALL Medical Research, LLC
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Hialeah, Florida, Forente stater, 33012
- Neostart Corporation dba AGA Clinical Trials
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Jacksonville, Florida, Forente stater, 32277
- Care Partners Clinical Research
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Jupiter, Florida, Forente stater, 33458
- Health Awareness, Inc.
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Kissimmee, Florida, Forente stater, 34741
- Family Health Care Clinical Studies
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Lakeland, Florida, Forente stater, 33810
- Clinical Research of Central Florida-Lakeland
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Miami, Florida, Forente stater, 33014
- Clinical Pharmacology of Miami, Inc.
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Miami, Florida, Forente stater, 33173
- Tellus Clinical Research, Inc.
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Miami, Florida, Forente stater, 33183
- Internal Research Associates LLC - Breton
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Orlando, Florida, Forente stater, 32801
- Clinical Neuroscience Solutions, Inc. Healthcare Orlando
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Ormond Beach, Florida, Forente stater, 32174
- Ormond Medical Arts Pharmaceutical Research Center
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Pembroke Pines, Florida, Forente stater, 33026
- Private Practice - Andres Patron, DO
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Port Orange, Florida, Forente stater, 32127
- Progressive Medical Research
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Saint Petersburg, Florida, Forente stater, 33709
- Meridien Reserach - St. Petersburg
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Tampa, Florida, Forente stater, 33634
- Meridien Research - Tampa
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Tampa, Florida, Forente stater, 33607
- Clinical Reserch Trials of Florida
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West Palm Beach, Florida, Forente stater, 33401
- Metabolic Research Institute, Inc.
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Illinois
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Addison, Illinois, Forente stater, 60101
- Biofortis, Inc.
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Aurora, Illinois, Forente stater, 60506
- AMR Sakeena Research
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Chicago, Illinois, Forente stater, 60607
- Cedar-Crosse Research Center
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Evanston, Illinois, Forente stater, 60201
- Evanston Premier Healthcare Research LLC
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Indiana
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Valparaiso, Indiana, Forente stater, 46383
- Buynak Clinical Research, PC
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Iowa
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West Des Moines, Iowa, Forente stater, 50266
- The Iowa Clinic; Cardiovascular Services
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Kansas
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Augusta, Kansas, Forente stater, 67010
- Heartland Research Associates, LLC - Augusta
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Topeka, Kansas, Forente stater, 66606
- Cotton-O'Neil Clinical Research Center
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Kentucky
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Edgewood, Kentucky, Forente stater, 41017
- Otrimed
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Lexington, Kentucky, Forente stater, 40503
- Kentucky Diabetes Endocrinology Center
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Louisville, Kentucky, Forente stater, 40213
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
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Paducah, Kentucky, Forente stater, 42003
- Four Rivers Clinical Research
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Louisiana
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Crowley, Louisiana, Forente stater, 70526
- Avant Research Associates
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Lake Charles, Louisiana, Forente stater, 70601
- Centex Studies, Inc. - Lake Charles
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Maryland
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Columbia, Maryland, Forente stater, 21045
- Columbia Medical Practice
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Hyattsville, Maryland, Forente stater, 20782
- Medstar Health Research Institute
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Oxon Hill, Maryland, Forente stater, 20745
- MD Medical Research
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Massachusetts
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Quincy, Massachusetts, Forente stater, 02169
- Beacon Clinical Research
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Minnesota
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Edina, Minnesota, Forente stater, 55435
- Radiant Research - Edina
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Mississippi
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Port Gibson, Mississippi, Forente stater, 39150
- Planters Clinic
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Montana
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Butte, Montana, Forente stater, 59701
- Mercury Street Medical Group, PLLC
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Nebraska
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Omaha, Nebraska, Forente stater, 68114
- Quality Clinical Research, Inc.
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Omaha, Nebraska, Forente stater, 68134
- Heartland Clinical Research
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Nevada
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Las Vegas, Nevada, Forente stater, 89119
- AB Clinical Trials
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Las Vegas, Nevada, Forente stater, 89101
- Alliance Against Diabetes
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Las Vegas, Nevada, Forente stater, 89128
- Palm Medical Research
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Las Vegas, Nevada, Forente stater, 89146
- Ingham Neuroscience Group, LLC
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New Jersey
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Berlin, New Jersey, Forente stater, 08009
- Comprehensive Clinical Research
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87109
- Albuquerque Neuroscience, Inc.
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Albuquerque, New Mexico, Forente stater, 87102
- Albuquerque Clinical Trials
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New York
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Brooklyn, New York, Forente stater, 11235
- NY Scientific
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Great Neck, New York, Forente stater, 11023
- Long Island Gastrointestinal Research Group
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Hopewell Junction, New York, Forente stater, 12533
- Mid-Hudson Medical Research, PLLC
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Westfield, New York, Forente stater, 14787
- Great Lakes Medical Research
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North Carolina
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Greensboro, North Carolina, Forente stater, 27408
- PharmQuest
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Greensboro, North Carolina, Forente stater, 27410
- Triad Clinical Trials LLC
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Rocky Mount, North Carolina, Forente stater, 27804
- PMG Research of Rocky Mount
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Salisbury, North Carolina, Forente stater, 28144
- PMG Research of Salisbury, LLC
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Wilmington, North Carolina, Forente stater, 28401
- PMG Research of Wilmington, LLC
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Ohio
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Cincinnati, Ohio, Forente stater, 45242
- New Horizons Clinical Research
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Cincinnati, Ohio, Forente stater, 45219
- Sterling Research Group, Ltd
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Cincinnati, Ohio, Forente stater, 45227
- Metabolic Atherosclerosis Research Center
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Columbus, Ohio, Forente stater, 43214
- Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health
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Franklin, Ohio, Forente stater, 45005
- Prestige Clinical Research
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Huber Heights, Ohio, Forente stater, 45424
- Hometown Urgent Care and Research - Huber Heights
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Marion, Ohio, Forente stater, 43302
- RAS Health LTD
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Stow, Ohio, Forente stater, 44224
- Summit Reserach Group, LLC
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73103
- COR Clinical Research, LLC
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Oregon
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Eugene, Oregon, Forente stater, 97404
- Willamette Valley Clinical Studies
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Pennsylvania
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Downingtown, Pennsylvania, Forente stater, 19335
- Brandywine Clinical Research
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South Carolina
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Charleston, South Carolina, Forente stater, 29407
- Medical Research South, LLC
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Greer, South Carolina, Forente stater, 29651
- Mountain View CLinical Research - Greer
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Mount Pleasant, South Carolina, Forente stater, 29464
- PMG of Charleston, LLC
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Myrtle Beach, South Carolina, Forente stater, 29588
- Family Medicine of SayeBrook, LLC
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Simpsonville, South Carolina, Forente stater, 29681
- Hillcrest Clinical Research, LLC
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Spartanburg, South Carolina, Forente stater, 29303
- Spartanburg Medical Research
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Spartanburg, South Carolina, Forente stater, 29301
- Palmetto Proactive Healthcare, LLC
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Summerville, South Carolina, Forente stater, 29485
- Palmetto Clinical Research
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Tennessee
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Bristol, Tennessee, Forente stater, 37620
- PMG Research of Bristol, LC - State
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Knoxville, Tennessee, Forente stater, 37912
- PMG Research of Knoxville
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Memphis, Tennessee, Forente stater, 38119
- Clinical Neuroscience Solutions, Inc. - Memphis
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Tullahoma, Tennessee, Forente stater, 37388
- Trinity Clinical Research
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Texas
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Austin, Texas, Forente stater, 78705
- Central Texas Clinical Research
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Carrollton, Texas, Forente stater, 75007
- Trinity Universal Research Associates, Inc.
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Dallas, Texas, Forente stater, 75230
- Dallas Diabetes and Endocrine Center
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Dallas, Texas, Forente stater, 75231
- Research Institute Of Dallas
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Dallas, Texas, Forente stater, 75251
- Galenos Research
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Houston, Texas, Forente stater, 77058
- Centex Studies, Inc.
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Houston, Texas, Forente stater, 77036
- Pioneer Research Solutions, Inc.
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Houston, Texas, Forente stater, 77074
- Clinical Trial Network - Houston
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Houston, Texas, Forente stater, 77074
- Juno Research, LLC-Houston
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Katy, Texas, Forente stater, 77450
- Juno Research, LLC-Katy
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San Antonio, Texas, Forente stater, 78215
- Sun Research Institute
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San Antonio, Texas, Forente stater, 78231
- Victorium Clinical Research
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San Antonio, Texas, Forente stater, 78207
- Texas Diabetes Institute Research Center
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Shavano Park, Texas, Forente stater, 78231
- Consano Clinical Research
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Sugar Land, Texas, Forente stater, 77478
- Southwest Health Associates, P.A.
-
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Utah
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Saint George, Utah, Forente stater, 84790
- Chrysalis Clinical Research
-
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Virginia
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Burke, Virginia, Forente stater, 22015
- Burke Internal Medicine & Research
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Manassas, Virginia, Forente stater, 20110
- Manassas Clinical Research Center
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Richmond, Virginia, Forente stater, 23235
- Clinical Research Partners, LLC
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Washington
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Tacoma, Washington, Forente stater, 98405
- Universal Research Group, LLC
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-
-
-
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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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
|
metformin tabletter med forsinket frigjøring
|
|
Eksperimentell: 900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
|
metformin tabletter med forsinket frigjøring
|
|
Eksperimentell: 1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
|
metformin tabletter med forsinket frigjøring
|
|
Eksperimentell: 1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
|
metformin tabletter med forsinket frigjøring
|
|
Placebo komparator: Placebo-1
placebo match for 600 and 1200 mg Met DR qAM treatment groups
|
|
|
Placebo komparator: Placebo-2
placebo match for 900 and 1500 mg Met DR qAM treatment groups
|
|
|
Aktiv komparator: 2000 mg Met IR
1000 mg metformin immediate-release twice daily
|
metformin immediate-release tablets
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in HbA1c (%) at 16 Weeks
Tidsramme: Baseline and 16 weeks after the first dose of study medication
|
Baseline and 16 weeks after the first dose of study medication
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Juan P Frias, MD, National Research Institute - Wilshire
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2015
Primær fullføring (Faktiske)
1. september 2016
Studiet fullført (Faktiske)
1. september 2016
Datoer for studieregistrering
Først innsendt
16. august 2015
Først innsendt som oppfylte QC-kriteriene
17. august 2015
Først lagt ut (Anslag)
18. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. april 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. mars 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LCRM112
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .