Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
27 mars 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
571
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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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, États-Unis, 36207
- Pinnacle Research Group, Llc
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Birmingham, Alabama, États-Unis, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, États-Unis, 35216
- Achieve Clinical Research, LLC
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Birmingham, Alabama, États-Unis, 35209
- Central Alabama Research
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Tuscumbia, Alabama, États-Unis, 35674
- Terence T. Hart, MD
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Arizona
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Chandler, Arizona, États-Unis, 85224
- Radiant Research - Phoenix
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Glendale, Arizona, États-Unis, 85306
- Arrowhead Health Centers
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Peoria, Arizona, États-Unis, 85381
- Holland Center for Family Health, LTD
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Phoenix, Arizona, États-Unis, 85018
- Elite Clinical Studies
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Phoenix, Arizona, États-Unis, 85037
- Thunderbird Internal Medicine - Indian School Rd.
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Surprise, Arizona, États-Unis, 85374
- Clinical Research Institute of Arizona, LLC
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Arkansas
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Fayetteville, Arkansas, États-Unis, 72703
- Summit Clinical Trials Center
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Searcy, Arkansas, États-Unis, 72143
- Searcy Medical Center
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California
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Escondido, California, États-Unis, 92025
- Advanced Metabolic Care & Research Institute (AMCR)
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Fountain Valley, California, États-Unis, 92708
- MD Studies, Inc.
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Huntington Park, California, États-Unis, 90255
- National Research Institute
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La Jolla, California, États-Unis, 92037
- Scripps Whittier Diabetes Institute
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Lincoln, California, États-Unis, 95648
- Clinical Trials Research
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Long Beach, California, États-Unis, 90806
- Collaborative Neuroscience Network, LLC
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Los Angeles, California, États-Unis, 90057
- National Research Institute
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Montclair, California, États-Unis, 91763
- Catalina Research Institute
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National City, California, États-Unis, 91950
- SRSD, Inc. dba Synergy San Diego
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North Hollywood, California, États-Unis, 91606
- Providence Clinical Research
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Oakland, California, États-Unis, 94607
- Pacific Research Partners, LLC
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Orange, California, États-Unis, 92868
- SDS Clinical Trials, Inc.
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Sacramento, California, États-Unis, 95825
- Superior Research LLC
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Sacramento, California, États-Unis, 95823
- Center for Clinical Trials of Sacramento
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Sacramento, California, États-Unis, 95823
- Center for Clinical Trials of Scaramento
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Santa Ana, California, États-Unis, 92705
- Syrentis Clinical Research (formerly Research Across America)
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Spring Valley, California, États-Unis, 91978
- Encompass Clinical Research
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Tustin, California, États-Unis, 92780
- Clinical Trial Investigators
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Van Nuys, California, États-Unis, 91405
- Infosphere Clinical Research
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Colorado
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Colorado Springs, Colorado, États-Unis, 80906
- Colorado Springs Health Partners
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Denver, Colorado, États-Unis, 80209
- Creekside Endocrine Associates
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Florida
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Brooksville, Florida, États-Unis, 34601
- Meridien Research - Brooksville
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Cooper City, Florida, États-Unis, 33024
- ALL Medical Research, LLC
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Hialeah, Florida, États-Unis, 33012
- Neostart Corporation dba AGA Clinical Trials
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Jacksonville, Florida, États-Unis, 32277
- Care Partners Clinical Research
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Jupiter, Florida, États-Unis, 33458
- Health Awareness, Inc.
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Kissimmee, Florida, États-Unis, 34741
- Family Health Care Clinical Studies
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Lakeland, Florida, États-Unis, 33810
- Clinical Research of Central Florida-Lakeland
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Miami, Florida, États-Unis, 33014
- Clinical Pharmacology of Miami, Inc.
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Miami, Florida, États-Unis, 33173
- Tellus Clinical Research, Inc.
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Miami, Florida, États-Unis, 33183
- Internal Research Associates LLC - Breton
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Orlando, Florida, États-Unis, 32801
- Clinical Neuroscience Solutions, Inc. Healthcare Orlando
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Ormond Beach, Florida, États-Unis, 32174
- Ormond Medical Arts Pharmaceutical Research Center
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Pembroke Pines, Florida, États-Unis, 33026
- Private Practice - Andres Patron, DO
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Port Orange, Florida, États-Unis, 32127
- Progressive Medical Research
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Saint Petersburg, Florida, États-Unis, 33709
- Meridien Reserach - St. Petersburg
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Tampa, Florida, États-Unis, 33634
- Meridien Research - Tampa
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Tampa, Florida, États-Unis, 33607
- Clinical Reserch Trials of Florida
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West Palm Beach, Florida, États-Unis, 33401
- Metabolic Research Institute, Inc.
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Illinois
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Addison, Illinois, États-Unis, 60101
- Biofortis, Inc.
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Aurora, Illinois, États-Unis, 60506
- AMR Sakeena Research
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Chicago, Illinois, États-Unis, 60607
- Cedar-Crosse Research Center
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Evanston, Illinois, États-Unis, 60201
- Evanston Premier Healthcare Research LLC
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Indiana
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Valparaiso, Indiana, États-Unis, 46383
- Buynak Clinical Research, PC
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Iowa
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West Des Moines, Iowa, États-Unis, 50266
- The Iowa Clinic; Cardiovascular Services
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Kansas
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Augusta, Kansas, États-Unis, 67010
- Heartland Research Associates, LLC - Augusta
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Topeka, Kansas, États-Unis, 66606
- Cotton-O'Neil Clinical Research Center
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Kentucky
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Edgewood, Kentucky, États-Unis, 41017
- Otrimed
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Lexington, Kentucky, États-Unis, 40503
- Kentucky Diabetes Endocrinology Center
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Louisville, Kentucky, États-Unis, 40213
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
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Paducah, Kentucky, États-Unis, 42003
- Four Rivers Clinical Research
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Louisiana
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Crowley, Louisiana, États-Unis, 70526
- Avant Research Associates
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Lake Charles, Louisiana, États-Unis, 70601
- Centex Studies, Inc. - Lake Charles
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Maryland
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Columbia, Maryland, États-Unis, 21045
- Columbia Medical Practice
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Hyattsville, Maryland, États-Unis, 20782
- Medstar Health Research Institute
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Oxon Hill, Maryland, États-Unis, 20745
- MD Medical Research
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Massachusetts
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Quincy, Massachusetts, États-Unis, 02169
- Beacon Clinical Research
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Minnesota
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Edina, Minnesota, États-Unis, 55435
- Radiant Research - Edina
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Mississippi
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Port Gibson, Mississippi, États-Unis, 39150
- Planters Clinic
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Montana
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Butte, Montana, États-Unis, 59701
- Mercury Street Medical Group, PLLC
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Nebraska
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Omaha, Nebraska, États-Unis, 68114
- Quality Clinical Research, Inc.
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Omaha, Nebraska, États-Unis, 68134
- Heartland Clinical Research
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Nevada
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Las Vegas, Nevada, États-Unis, 89119
- AB Clinical Trials
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Las Vegas, Nevada, États-Unis, 89101
- Alliance Against Diabetes
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Las Vegas, Nevada, États-Unis, 89128
- Palm Medical Research
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Las Vegas, Nevada, États-Unis, 89146
- Ingham Neuroscience Group, LLC
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New Jersey
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Berlin, New Jersey, États-Unis, 08009
- Comprehensive Clinical Research
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87109
- Albuquerque Neuroscience, Inc.
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Albuquerque, New Mexico, États-Unis, 87102
- Albuquerque Clinical Trials
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New York
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Brooklyn, New York, États-Unis, 11235
- NY Scientific
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Great Neck, New York, États-Unis, 11023
- Long Island Gastrointestinal Research Group
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Hopewell Junction, New York, États-Unis, 12533
- Mid-Hudson Medical Research, PLLC
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Westfield, New York, États-Unis, 14787
- Great Lakes Medical Research
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North Carolina
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Greensboro, North Carolina, États-Unis, 27408
- PharmQuest
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Greensboro, North Carolina, États-Unis, 27410
- Triad Clinical Trials LLC
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Rocky Mount, North Carolina, États-Unis, 27804
- PMG Research of Rocky Mount
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Salisbury, North Carolina, États-Unis, 28144
- PMG Research of Salisbury, LLC
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Wilmington, North Carolina, États-Unis, 28401
- PMG Research of Wilmington, LLC
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Ohio
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Cincinnati, Ohio, États-Unis, 45242
- New Horizons Clinical Research
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Cincinnati, Ohio, États-Unis, 45219
- Sterling Research Group, Ltd
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Cincinnati, Ohio, États-Unis, 45227
- Metabolic Atherosclerosis Research Center
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Columbus, Ohio, États-Unis, 43214
- Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health
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Franklin, Ohio, États-Unis, 45005
- Prestige Clinical Research
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Huber Heights, Ohio, États-Unis, 45424
- Hometown Urgent Care and Research - Huber Heights
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Marion, Ohio, États-Unis, 43302
- RAS Health LTD
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Stow, Ohio, États-Unis, 44224
- Summit Reserach Group, LLC
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73103
- COR Clinical Research, LLC
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Oregon
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Eugene, Oregon, États-Unis, 97404
- Willamette Valley Clinical Studies
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Pennsylvania
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Downingtown, Pennsylvania, États-Unis, 19335
- Brandywine Clinical Research
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South Carolina
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Charleston, South Carolina, États-Unis, 29407
- Medical Research South, LLC
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Greer, South Carolina, États-Unis, 29651
- Mountain View CLinical Research - Greer
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Mount Pleasant, South Carolina, États-Unis, 29464
- PMG of Charleston, LLC
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Myrtle Beach, South Carolina, États-Unis, 29588
- Family Medicine of SayeBrook, LLC
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Simpsonville, South Carolina, États-Unis, 29681
- Hillcrest Clinical Research, LLC
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Spartanburg, South Carolina, États-Unis, 29303
- Spartanburg Medical Research
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Spartanburg, South Carolina, États-Unis, 29301
- Palmetto Proactive Healthcare, LLC
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Summerville, South Carolina, États-Unis, 29485
- Palmetto Clinical Research
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Tennessee
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Bristol, Tennessee, États-Unis, 37620
- PMG Research of Bristol, LC - State
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Knoxville, Tennessee, États-Unis, 37912
- PMG Research of Knoxville
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Memphis, Tennessee, États-Unis, 38119
- Clinical Neuroscience Solutions, Inc. - Memphis
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Tullahoma, Tennessee, États-Unis, 37388
- Trinity Clinical Research
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Texas
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Austin, Texas, États-Unis, 78705
- Central Texas Clinical Research
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Carrollton, Texas, États-Unis, 75007
- Trinity Universal Research Associates, Inc.
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Dallas, Texas, États-Unis, 75230
- Dallas Diabetes and Endocrine Center
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Dallas, Texas, États-Unis, 75231
- Research Institute Of Dallas
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Dallas, Texas, États-Unis, 75251
- Galenos Research
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Houston, Texas, États-Unis, 77058
- Centex Studies, Inc.
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Houston, Texas, États-Unis, 77036
- Pioneer Research Solutions, Inc.
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Houston, Texas, États-Unis, 77074
- Clinical Trial Network - Houston
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Houston, Texas, États-Unis, 77074
- Juno Research, LLC-Houston
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Katy, Texas, États-Unis, 77450
- Juno Research, LLC-Katy
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San Antonio, Texas, États-Unis, 78215
- Sun Research Institute
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San Antonio, Texas, États-Unis, 78231
- Victorium Clinical Research
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San Antonio, Texas, États-Unis, 78207
- Texas Diabetes Institute Research Center
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Shavano Park, Texas, États-Unis, 78231
- Consano Clinical Research
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Sugar Land, Texas, États-Unis, 77478
- Southwest Health Associates, P.A.
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Utah
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Saint George, Utah, États-Unis, 84790
- Chrysalis Clinical Research
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Virginia
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Burke, Virginia, États-Unis, 22015
- Burke Internal Medicine & Research
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Manassas, Virginia, États-Unis, 20110
- Manassas Clinical Research Center
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Richmond, Virginia, États-Unis, 23235
- Clinical Research Partners, LLC
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Washington
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Tacoma, Washington, États-Unis, 98405
- Universal Research Group, LLC
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
25 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
|
comprimés à libération retardée de metformine
|
|
Expérimental: 900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
|
comprimés à libération retardée de metformine
|
|
Expérimental: 1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
|
comprimés à libération retardée de metformine
|
|
Expérimental: 1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
|
comprimés à libération retardée de metformine
|
|
Comparateur placebo: Placebo-1
placebo match for 600 and 1200 mg Met DR qAM treatment groups
|
|
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Comparateur placebo: Placebo-2
placebo match for 900 and 1500 mg Met DR qAM treatment groups
|
|
|
Comparateur actif: 2000 mg Met IR
1000 mg metformin immediate-release twice daily
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metformin immediate-release tablets
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change in HbA1c (%) at 16 Weeks
Délai: Baseline and 16 weeks after the first dose of study medication
|
Baseline and 16 weeks after the first dose of study medication
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Juan P Frias, MD, National Research Institute - Wilshire
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2015
Achèvement primaire (Réel)
1 septembre 2016
Achèvement de l'étude (Réel)
1 septembre 2016
Dates d'inscription aux études
Première soumission
16 août 2015
Première soumission répondant aux critères de contrôle qualité
17 août 2015
Première publication (Estimation)
18 août 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 avril 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 mars 2018
Dernière vérification
1 mars 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LCRM112
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .