Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
This trial has been completed.
|Condition||type 2 diabetes mellitus|
|Treatments||met dr, met ir, placebo|
|Sponsor||Elcelyx Therapeutics, Inc.|
|Start date||September 2015|
|End date||September 2016|
|Trial size||571 participants|
|Trial identifier||NCT02526524, LCRM112|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Anniston, AL||Pinnacle Research Group, LLC||completed|
|Birmingham, AL||Central Alabama Research||completed|
|Birmingham, AL||Achieve Clinical Research, LLC||completed|
|Birmingham, AL||University of Alabama at Birmingham||completed|
|Tuscumbia, AL||Terence T. Hart, MD||completed|
|Chandler, AZ||Radiant Research - Phoenix||completed|
|Glendale, AZ||Arrowhead Health Centers||completed|
|Peoria, AZ||Holland Center for Family Health, LTD||completed|
|Phoenix, AZ||Elite Clinical Studies||completed|
|Phoenix, AZ||Thunderbird Internal Medicine - Indian School Rd.||completed|
|Surprise, AZ||Clinical Research Institute of Arizona, LLC||completed|
|Fayetteville, AR||Summit Clinical Trials Center||completed|
|Searcy, AR||Searcy Medical Center||completed|
|Escondido, CA||Advanced Metabolic Care & Research Institute (AMCR)||completed|
|Fountain Valley, CA||MD Studies, Inc.||completed|
|Huntington Park, CA||National Research Institute||completed|
|La Jolla, CA||Scripps Whittier Diabetes Institute||completed|
|Lincoln, CA||Clinical Trials Research||completed|
|Long Beach, CA||Collaborative Neuroscience Network, LLC||completed|
|Los Angeles, CA||National Research Institute||completed|
|Montclair, CA||Catalina Research Institute||completed|
|National City, CA||SRSD, Inc. dba Synergy San Diego||completed|
|North Hollywood, CA||Providence Clinical Research||completed|
|Oakland, CA||Pacific Research Partners, LLC||completed|
|Orange, CA||SDS Clinical Trials, Inc.||completed|
|Sacramento, CA||Center for Clinical Trials of Sacramento||completed|
|Sacramento, CA||Center for Clinical Trials of Scaramento||completed|
|Sacramento, CA||Superior Research LLC||completed|
|Santa Ana, CA||Syrentis Clinical Research (formerly Research Across America)||completed|
|Spring Valley, CA||Encompass Clinical Research||completed|
|Tustin, CA||Clinical Trial Investigators||completed|
|Van Nuys, CA||Infosphere Clinical Research||completed|
|Colorado Springs, CO||Colorado Springs Health Partners||completed|
|Denver, CO||Creekside Endocrine Associates||completed|
|Brooksville, FL||Meridien Research - Brooksville||completed|
|Cooper City, FL||ALL Medical Research, LLC||completed|
|Hialeah, FL||Neostart Corporation dba AGA Clinical Trials||completed|
|Jacksonville, FL||Care Partners Clinical Research||completed|
|Jupiter, FL||Health Awareness, Inc.||completed|
|Kissimmee, FL||Family Health Care Clinical Studies||completed|
|Lakeland, FL||Clinical Research of Central Florida-Lakeland||completed|
|Miami, FL||Clinical Pharmacology of Miami, Inc.||completed|
|Miami, FL||Tellus Clinical Research, Inc.||completed|
|Miami, FL||Internal Research Associates LLC - Breton||completed|
|Orlando, FL||Clinical Neuroscience Solutions, Inc. Healthcare Orlando||completed|
|Ormond Beach, FL||Ormond Medical Arts Pharmaceutical Research Center||completed|
|Pembroke Pines, FL||Private Practice - Andres Patron, DO||completed|
|Port Orange, FL||Progressive Medical Research||completed|
|St. Petersburg, FL||Meridien Reserach - St. Petersburg||completed|
|Tampa, FL||Clinical Reserch Trials of Florida||completed|
|Tampa, FL||Meridien Research - Tampa||completed|
|West Palm Beach, FL||Metabolic Research Institute, Inc.||completed|
|Addison, IL||Biofortis, Inc.||completed|
|Aurora, IL||AMR Sakeena Research||completed|
|Chicago, IL||Cedar-Crosse Research Center||completed|
|Evanston, IL||Evanston Premier Healthcare Research LLC||completed|
|Valparaiso, IN||Buynak Clinical Research, PC||completed|
|West Des Moines, IA||The Iowa Clinic; Cardiovascular Services||completed|
|Augusta, KS||Heartland Research Associates, LLC - Augusta||completed|
|Topeka, KS||Cotton-O'Neil Clinical Research Center||completed|
|Lexington, KY||Kentucky Diabetes Endocrinology Center||completed|
|Louisville, KY||Louisville Metabolic and Atherosclerosis Research Center (L-MARC)||completed|
|Paducah, KY||Four Rivers Clinical Research||completed|
|Crowley, LA||Avant Research Associates||completed|
|Lake Charles, LA||Centex Studies, Inc. - lake Charles||completed|
|Columbia, MD||Columbia Medical Practice||completed|
|Hyattsville, MD||Medstar Health Research Institute||completed|
|Oxon Hill, MD||MD Medical Research||completed|
|Quincy, MA||Beacon Clinical Research||completed|
|Edina, MN||Radiant Research - Edina||completed|
|Port Gibson, MS||Planters Clinic||completed|
|Butte, MT||Mercury Street Medical Group, PLLC||completed|
|Omaha, NE||Quality Clinical Research, Inc.||completed|
|Omaha, NE||Heartland Clinical Research||completed|
|Las Vegas, NV||Alliance Against Diabetes||completed|
|Las Vegas, NV||AB Clinical Trials||completed|
|Las Vegas, NV||Palm Medical Research||completed|
|Las Vegas, NV||Ingham Neuroscience Group, LLC||completed|
|Berlin, NJ||Comprehensive Clinical Research||completed|
|Albuquerque, NM||Albuquerque Clinical Trials||completed|
|Albuquerque, NM||Albuquerque Neuroscience, Inc.||completed|
|Brooklyn, NY||NY Scientific||completed|
|Great Neck, NY||Long Island Gastrointestinal Research Group||completed|
|Hopewell Junction, NY||Mid-Hudson Medical Research, PLLC||completed|
|Westfield, NY||Great Lakes Medical Research||completed|
|Greensboro, NC||Triad Clinical Trials LLC||completed|
|Rocky Mount, NC||PMG Research of Rocky Mount||completed|
|Salisbury, NC||PMG Research of Salisbury, LLC||completed|
|Wilmington, NC||PMG Research of Wilmington, LLC||completed|
|Cincinnati, OH||Sterling Research Group, Ltd||completed|
|Cincinnati, OH||Metabolic Atherosclerosis Research Center||completed|
|Cincinnati, OH||New Horizons Clinical Research||completed|
|Columbus, OH||Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health||completed|
|Franklin, OH||Prestige Clinical Research||completed|
|Huber Heights, OH||Hometown Urgent Care and Research - Huber Heights||completed|
|Marion, OH||RAS Health LTD||completed|
|Stow, OH||Summit Reserach Group, LLC||completed|
|Oklahoma City, OK||COR Clinical Research, LLC||completed|
|Eugene, OR||Willamette Valley Clinical Studies||completed|
|Downington, PA||Brandywine Clinical Research||completed|
|Charleston, SC||Medical Research South, LLC||completed|
|Greer, SC||Mountain View Clinical Research - Greer||completed|
|Mt. Pleasant, SC||PMG of Charleston, LLC||completed|
|Myrtle Beach, SC||Family Medicine of SayeBrook, LLC||completed|
|Simpsonville, SC||Hillcrest Clinical Research, LLC||completed|
|Spartanburg, SC||Palmetto Proactive Healthcare, LLC||completed|
|Spartanburg, SC||Spartanburg Medical Research||completed|
|Summerville, SC||Palmetto Clinical Research||completed|
|Bristol, TN||PMG Research of Bristol, LC - State||completed|
|Knoxville, TN||PMG Research of Knoxville||completed|
|Memphis, TN||Clinical Neuroscience Solutions, Inc. - Memphis||completed|
|Tullahoma, TN||Trinity Clinical Research||completed|
|Austin, TX||Central Texas Clinical Research||completed|
|Carrollton, TX||Trinity Universal Research Associates, Inc.||completed|
|Dallas, TX||Dallas Diabetes and Endocrine Center||completed|
|Dallas, TX||Research Institute of Dallas||completed|
|Dallas, TX||Galenos Research||completed|
|Houston, TX||Pioneer Research Solutions, Inc.||completed|
|Houston, TX||Centex Studies, Inc.||completed|
|Houston, TX||Clinical Trial Network - Houston||completed|
|Houston, TX||Juno Research, LLC-Houston||completed|
|Katy, TX||Juno Research, LLC-Katy||completed|
|San Antonio, TX||Texas Diabetes Institute Research Center||completed|
|San Antonio, TX||Sun Research Institute||completed|
|San Antonio, TX||Victorium Clinical Research||completed|
|Shavano Park, TX||Consano Clinical Research||completed|
|Sugarland, TX||Southwest Health Associates, P.A.||completed|
|St. George, UT||Chrysalis Clinical Research||completed|
|Burke, VA||Burke Internal Medicine & Research||completed|
|Manassas, VA||Manassas Clinical Research Center||completed|
|Richmond, VA||Clinical Research Partners, LLC||completed|
|Tacoma, WA||Universal Research Group, LLC||completed|
|Carolina, Puerto Rico||Puerto Rico Renal and Health Research, Inc.||completed|
|Cidra, Puerto Rico||Advanced Medical Concepts||completed|
|Manati, Puerto Rico||Manati Center for Clinical Reserach Doctor's Center Hospital||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change in HbA1c (%) at 16 Weeks
time frame: Baseline and 16 weeks after the first dose of study medication
Male or female participants at least 25 years old.
- 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.
- 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.
|Official title||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|
|Principal investigator||Juan P Frias, MD|
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