Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
27 marzo 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
571
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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Alabama
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Anniston, Alabama, Stati Uniti, 36207
- Pinnacle Research Group, LLC
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Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Stati Uniti, 35216
- Achieve Clinical Research, LLC
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Birmingham, Alabama, Stati Uniti, 35209
- Central Alabama Research
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Tuscumbia, Alabama, Stati Uniti, 35674
- Terence T. Hart, MD
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Arizona
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Chandler, Arizona, Stati Uniti, 85224
- Radiant Research - Phoenix
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Glendale, Arizona, Stati Uniti, 85306
- Arrowhead Health Centers
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Peoria, Arizona, Stati Uniti, 85381
- Holland Center for Family Health, LTD
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Phoenix, Arizona, Stati Uniti, 85018
- Elite Clinical Studies
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Phoenix, Arizona, Stati Uniti, 85037
- Thunderbird Internal Medicine - Indian School Rd.
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Surprise, Arizona, Stati Uniti, 85374
- Clinical Research Institute of Arizona, LLC
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Arkansas
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Fayetteville, Arkansas, Stati Uniti, 72703
- Summit Clinical Trials Center
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Searcy, Arkansas, Stati Uniti, 72143
- Searcy Medical Center
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California
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Escondido, California, Stati Uniti, 92025
- Advanced Metabolic Care & Research Institute (AMCR)
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Fountain Valley, California, Stati Uniti, 92708
- MD Studies, Inc.
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Huntington Park, California, Stati Uniti, 90255
- National Research Institute
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La Jolla, California, Stati Uniti, 92037
- Scripps Whittier Diabetes Institute
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Lincoln, California, Stati Uniti, 95648
- Clinical Trials Research
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Long Beach, California, Stati Uniti, 90806
- Collaborative Neuroscience Network, LLC
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Los Angeles, California, Stati Uniti, 90057
- National Research Institute
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Montclair, California, Stati Uniti, 91763
- Catalina Research Institute
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National City, California, Stati Uniti, 91950
- SRSD, Inc. dba Synergy San Diego
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North Hollywood, California, Stati Uniti, 91606
- Providence Clinical Research
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Oakland, California, Stati Uniti, 94607
- Pacific Research Partners, LLC
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Orange, California, Stati Uniti, 92868
- SDS Clinical Trials, Inc.
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Sacramento, California, Stati Uniti, 95825
- Superior Research LLC
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Sacramento, California, Stati Uniti, 95823
- Center for Clinical Trials of Sacramento
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Sacramento, California, Stati Uniti, 95823
- Center for Clinical Trials of Scaramento
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Santa Ana, California, Stati Uniti, 92705
- Syrentis Clinical Research (formerly Research Across America)
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Spring Valley, California, Stati Uniti, 91978
- Encompass Clinical Research
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Tustin, California, Stati Uniti, 92780
- Clinical Trial Investigators
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Van Nuys, California, Stati Uniti, 91405
- Infosphere Clinical Research
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80906
- Colorado Springs Health Partners
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Denver, Colorado, Stati Uniti, 80209
- Creekside Endocrine Associates
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Florida
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Brooksville, Florida, Stati Uniti, 34601
- Meridien Research - Brooksville
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Cooper City, Florida, Stati Uniti, 33024
- ALL Medical Research, LLC
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Hialeah, Florida, Stati Uniti, 33012
- Neostart Corporation dba AGA Clinical Trials
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Jacksonville, Florida, Stati Uniti, 32277
- Care Partners Clinical Research
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Jupiter, Florida, Stati Uniti, 33458
- Health Awareness, Inc.
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Kissimmee, Florida, Stati Uniti, 34741
- Family Health Care Clinical Studies
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Lakeland, Florida, Stati Uniti, 33810
- Clinical Research of Central Florida-Lakeland
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Miami, Florida, Stati Uniti, 33014
- Clinical Pharmacology of Miami, Inc.
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Miami, Florida, Stati Uniti, 33173
- Tellus Clinical Research, Inc.
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Miami, Florida, Stati Uniti, 33183
- Internal Research Associates LLC - Breton
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Orlando, Florida, Stati Uniti, 32801
- Clinical Neuroscience Solutions, Inc. Healthcare Orlando
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Ormond Beach, Florida, Stati Uniti, 32174
- Ormond Medical Arts Pharmaceutical Research Center
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Pembroke Pines, Florida, Stati Uniti, 33026
- Private Practice - Andres Patron, DO
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Port Orange, Florida, Stati Uniti, 32127
- Progressive Medical Research
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Saint Petersburg, Florida, Stati Uniti, 33709
- Meridien Reserach - St. Petersburg
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Tampa, Florida, Stati Uniti, 33634
- Meridien Research - Tampa
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Tampa, Florida, Stati Uniti, 33607
- Clinical Reserch Trials of Florida
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West Palm Beach, Florida, Stati Uniti, 33401
- Metabolic Research Institute, Inc.
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Illinois
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Addison, Illinois, Stati Uniti, 60101
- Biofortis, Inc.
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Aurora, Illinois, Stati Uniti, 60506
- AMR Sakeena Research
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Chicago, Illinois, Stati Uniti, 60607
- Cedar-Crosse Research Center
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Evanston, Illinois, Stati Uniti, 60201
- Evanston Premier Healthcare Research LLC
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Indiana
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Valparaiso, Indiana, Stati Uniti, 46383
- Buynak Clinical Research, PC
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Iowa
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West Des Moines, Iowa, Stati Uniti, 50266
- The Iowa Clinic; Cardiovascular Services
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Kansas
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Augusta, Kansas, Stati Uniti, 67010
- Heartland Research Associates, LLC - Augusta
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Topeka, Kansas, Stati Uniti, 66606
- Cotton-O'Neil Clinical Research Center
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Kentucky
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Edgewood, Kentucky, Stati Uniti, 41017
- Otrimed
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Lexington, Kentucky, Stati Uniti, 40503
- Kentucky Diabetes Endocrinology Center
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Louisville, Kentucky, Stati Uniti, 40213
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
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Paducah, Kentucky, Stati Uniti, 42003
- Four Rivers Clinical Research
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Louisiana
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Crowley, Louisiana, Stati Uniti, 70526
- Avant Research Associates
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Lake Charles, Louisiana, Stati Uniti, 70601
- Centex Studies, Inc. - Lake Charles
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Maryland
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Columbia, Maryland, Stati Uniti, 21045
- Columbia Medical Practice
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Hyattsville, Maryland, Stati Uniti, 20782
- MedStar Health Research Institute
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Oxon Hill, Maryland, Stati Uniti, 20745
- MD Medical Research
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Massachusetts
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Quincy, Massachusetts, Stati Uniti, 02169
- Beacon Clinical Research
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Minnesota
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Edina, Minnesota, Stati Uniti, 55435
- Radiant Research - Edina
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Mississippi
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Port Gibson, Mississippi, Stati Uniti, 39150
- Planters Clinic
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Montana
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Butte, Montana, Stati Uniti, 59701
- Mercury Street Medical Group, PLLC
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68114
- Quality Clinical Research, Inc.
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Omaha, Nebraska, Stati Uniti, 68134
- Heartland Clinical Research
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89119
- AB Clinical Trials
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Las Vegas, Nevada, Stati Uniti, 89101
- Alliance Against Diabetes
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Las Vegas, Nevada, Stati Uniti, 89128
- Palm Medical Research
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Las Vegas, Nevada, Stati Uniti, 89146
- Ingham Neuroscience Group, LLC
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New Jersey
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Berlin, New Jersey, Stati Uniti, 08009
- Comprehensive Clinical Research
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87109
- Albuquerque Neuroscience, Inc.
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Albuquerque, New Mexico, Stati Uniti, 87102
- Albuquerque Clinical Trials
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New York
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Brooklyn, New York, Stati Uniti, 11235
- NY Scientific
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Great Neck, New York, Stati Uniti, 11023
- Long Island Gastrointestinal Research Group
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Hopewell Junction, New York, Stati Uniti, 12533
- Mid-Hudson Medical Research, PLLC
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Westfield, New York, Stati Uniti, 14787
- Great Lakes Medical Research
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North Carolina
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Greensboro, North Carolina, Stati Uniti, 27408
- PharmQuest
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Greensboro, North Carolina, Stati Uniti, 27410
- Triad Clinical Trials LLC
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Rocky Mount, North Carolina, Stati Uniti, 27804
- PMG Research of Rocky Mount
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Salisbury, North Carolina, Stati Uniti, 28144
- PMG Research of Salisbury, LLC
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Wilmington, North Carolina, Stati Uniti, 28401
- PMG Research of Wilmington, LLC
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45242
- New Horizons Clinical Research
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Cincinnati, Ohio, Stati Uniti, 45219
- Sterling Research Group, Ltd
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Cincinnati, Ohio, Stati Uniti, 45227
- Metabolic Atherosclerosis Research Center
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Columbus, Ohio, Stati Uniti, 43214
- Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health
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Franklin, Ohio, Stati Uniti, 45005
- Prestige Clinical Research
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Huber Heights, Ohio, Stati Uniti, 45424
- Hometown Urgent Care and Research - Huber Heights
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Marion, Ohio, Stati Uniti, 43302
- RAS Health LTD
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Stow, Ohio, Stati Uniti, 44224
- Summit Reserach Group, LLC
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73103
- COR Clinical Research, LLC
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Oregon
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Eugene, Oregon, Stati Uniti, 97404
- Willamette Valley Clinical Studies
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Pennsylvania
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Downingtown, Pennsylvania, Stati Uniti, 19335
- Brandywine Clinical Research
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29407
- Medical Research South, LLC
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Greer, South Carolina, Stati Uniti, 29651
- Mountain View Clinical Research - Greer
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Mount Pleasant, South Carolina, Stati Uniti, 29464
- PMG of Charleston, LLC
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Myrtle Beach, South Carolina, Stati Uniti, 29588
- Family Medicine of SayeBrook, LLC
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Simpsonville, South Carolina, Stati Uniti, 29681
- Hillcrest Clinical Research, LLC
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Spartanburg, South Carolina, Stati Uniti, 29303
- Spartanburg Medical Research
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Spartanburg, South Carolina, Stati Uniti, 29301
- Palmetto Proactive Healthcare, LLC
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Summerville, South Carolina, Stati Uniti, 29485
- Palmetto Clinical Research
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Tennessee
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Bristol, Tennessee, Stati Uniti, 37620
- PMG Research of Bristol, LC - State
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Knoxville, Tennessee, Stati Uniti, 37912
- PMG Research of Knoxville
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Memphis, Tennessee, Stati Uniti, 38119
- Clinical Neuroscience Solutions, Inc. - Memphis
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Tullahoma, Tennessee, Stati Uniti, 37388
- Trinity Clinical Research
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Texas
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Austin, Texas, Stati Uniti, 78705
- Central Texas Clinical Research
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Carrollton, Texas, Stati Uniti, 75007
- Trinity Universal Research Associates, Inc.
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Dallas, Texas, Stati Uniti, 75230
- Dallas Diabetes and Endocrine Center
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Dallas, Texas, Stati Uniti, 75231
- Research Institute Of Dallas
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Dallas, Texas, Stati Uniti, 75251
- Galenos Research
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Houston, Texas, Stati Uniti, 77058
- Centex Studies, Inc.
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Houston, Texas, Stati Uniti, 77036
- Pioneer Research Solutions, Inc.
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Houston, Texas, Stati Uniti, 77074
- Clinical Trial Network - Houston
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Houston, Texas, Stati Uniti, 77074
- Juno Research, LLC-Houston
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Katy, Texas, Stati Uniti, 77450
- Juno Research, LLC-Katy
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San Antonio, Texas, Stati Uniti, 78215
- Sun Research Institute
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San Antonio, Texas, Stati Uniti, 78231
- Victorium Clinical Research
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San Antonio, Texas, Stati Uniti, 78207
- Texas Diabetes Institute Research Center
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Shavano Park, Texas, Stati Uniti, 78231
- Consano Clinical Research
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Sugar Land, Texas, Stati Uniti, 77478
- Southwest Health Associates, P.A.
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Utah
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Saint George, Utah, Stati Uniti, 84790
- Chrysalis Clinical Research
-
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Virginia
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Burke, Virginia, Stati Uniti, 22015
- Burke Internal Medicine & Research
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Manassas, Virginia, Stati Uniti, 20110
- Manassas Clinical Research Center
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Richmond, Virginia, Stati Uniti, 23235
- Clinical Research Partners, LLC
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Washington
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Tacoma, Washington, Stati Uniti, 98405
- Universal Research Group, LLC
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
25 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
|
metformina compresse a rilascio ritardato
|
|
Sperimentale: 900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
|
metformina compresse a rilascio ritardato
|
|
Sperimentale: 1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
|
metformina compresse a rilascio ritardato
|
|
Sperimentale: 1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
|
metformina compresse a rilascio ritardato
|
|
Comparatore placebo: Placebo-1
placebo match for 600 and 1200 mg Met DR qAM treatment groups
|
|
|
Comparatore placebo: Placebo-2
placebo match for 900 and 1500 mg Met DR qAM treatment groups
|
|
|
Comparatore attivo: 2000 mg Met IR
1000 mg metformin immediate-release twice daily
|
metformin immediate-release tablets
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Change in HbA1c (%) at 16 Weeks
Lasso di tempo: Baseline and 16 weeks after the first dose of study medication
|
Baseline and 16 weeks after the first dose of study medication
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Juan P Frias, MD, National Research Institute - Wilshire
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2015
Completamento primario (Effettivo)
1 settembre 2016
Completamento dello studio (Effettivo)
1 settembre 2016
Date di iscrizione allo studio
Primo inviato
16 agosto 2015
Primo inviato che soddisfa i criteri di controllo qualità
17 agosto 2015
Primo Inserito (Stima)
18 agosto 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 aprile 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 marzo 2018
Ultimo verificato
1 marzo 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LCRM112
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .