Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02526524
- Lead Sponsor
- Elcelyx Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 571
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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.
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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.
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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
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Ability to understand and willingness to adhere to protocol requirements.
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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.
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A history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within the past year.
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Prior major surgery of any kind within 6 months of Visit 1.
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A history of >3% weight change within 3 months of Visit 1.
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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.
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An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN.
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A physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study.
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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.
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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.
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Has known immune system based allergies or hypersensitivity to any component of study treatment. A history of gastrointestinal intolerance to metformin is not exclusionary.
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Is employed by Elcelyx Therapeutics, Inc. (that is an employee, contract worker, or designee of the company).
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1200 mg Met DR qAM Met DR 1200 mg metformin delayed-release once daily in the morning 1500 mg Met DR qAM Met DR 1500 mg metformin delayed-release once daily in the morning 600 mg Met DR qAM Met DR 600 mg metformin delayed-release once daily in the morning 900 mg Met DR qAM Met DR 900 mg metformin delayed-release once daily in the morning Placebo-1 Placebo placebo match for 600 and 1200 mg Met DR qAM treatment groups 2000 mg Met IR Met IR 1000 mg metformin immediate-release twice daily Placebo-2 Placebo placebo match for 900 and 1500 mg Met DR qAM treatment groups
- Primary Outcome Measures
Name Time Method Change in HbA1c (%) at 16 Weeks Baseline and 16 weeks after the first dose of study medication
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (136)
Clinical Pharmacology of Miami, Inc.
🇺🇸Miami, Florida, United States
Tellus Clinical Research, Inc.
🇺🇸Miami, Florida, United States
Columbia Medical Practice
🇺🇸Columbia, Maryland, United States
Mercury Street Medical Group, PLLC
🇺🇸Butte, Montana, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Dallas Diabetes and Endocrine Center
🇺🇸Dallas, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
Juno Research, LLC-Houston
🇺🇸Houston, Texas, United States
Southwest Health Associates, P.A.
🇺🇸Sugar Land, Texas, United States
Palm Medical Research
🇺🇸Las Vegas, Nevada, United States
Radiant Research - Phoenix
🇺🇸Chandler, Arizona, United States
PMG Research of Bristol, LC - State
🇺🇸Bristol, Tennessee, United States
ALL Medical Research, LLC
🇺🇸Cooper City, Florida, United States
Searcy Medical Center
🇺🇸Searcy, Arkansas, United States
Medstar Health Research Institute
🇺🇸Hyattsville, Maryland, United States
Clinical Research Institute of Arizona, LLC
🇺🇸Surprise, Arizona, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
Advanced Medical Concepts
🇵🇷Cidra, Puerto Rico
Care Partners Clinical Research
🇺🇸Jacksonville, Florida, United States
Clinical Research of Central Florida-Lakeland
🇺🇸Lakeland, Florida, United States
PMG Research of Knoxville
🇺🇸Knoxville, Tennessee, United States
Palmetto Proactive Healthcare, LLC
🇺🇸Spartanburg, South Carolina, United States
Neostart Corporation dba AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
🇺🇸Ormond Beach, Florida, United States
Family Medicine of SayeBrook, LLC
🇺🇸Myrtle Beach, South Carolina, United States
Manati Center for Clinical Reserach Doctor's Center Hospital
🇵🇷Manati, Puerto Rico
Clinical Neuroscience Solutions, Inc. - Memphis
🇺🇸Memphis, Tennessee, United States
PMG of Charleston, LLC
🇺🇸Mount Pleasant, South Carolina, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States
Ingham Neuroscience Group, LLC
🇺🇸Las Vegas, Nevada, United States
Puerto Rico Renal and Health Research, Inc.
🇵🇷Carolina, Puerto Rico
Mountain View Clinical Research - Greer
🇺🇸Greer, South Carolina, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Hillcrest Clinical Research, LLC
🇺🇸Simpsonville, South Carolina, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Victorium Clinical Research
🇺🇸San Antonio, Texas, United States
Arrowhead Health Centers
🇺🇸Glendale, Arizona, United States
Holland Center for Family Health, LTD
🇺🇸Peoria, Arizona, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Thunderbird Internal Medicine - Indian School Rd.
🇺🇸Phoenix, Arizona, United States
Catalina Research Institute
🇺🇸Montclair, California, United States
Infosphere Clinical Research
🇺🇸Van Nuys, California, United States
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Summit Clinical Trials Center
🇺🇸Fayetteville, Arkansas, United States
Heartland Research Associates, LLC - Augusta
🇺🇸Augusta, Kansas, United States
Cotton-O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Meridien Research - Brooksville
🇺🇸Brooksville, Florida, United States
Collaborative Neuroscience Network, LLC
🇺🇸Long Beach, California, United States
Radiant Research - Edina
🇺🇸Edina, Minnesota, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Colorado Springs Health Partners
🇺🇸Colorado Springs, Colorado, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Family Health Care Clinical Studies
🇺🇸Kissimmee, Florida, United States
Internal Research Associates LLC - Breton
🇺🇸Miami, Florida, United States
Biofortis, Inc.
🇺🇸Addison, Illinois, United States
Private Practice - Andres Patron, DO
🇺🇸Pembroke Pines, Florida, United States
Meridien Reserach - St. Petersburg
🇺🇸Saint Petersburg, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
NY Scientific
🇺🇸Brooklyn, New York, United States
Avant Research Associates
🇺🇸Crowley, Louisiana, United States
Centex Studies, Inc. - lake Charles
🇺🇸Lake Charles, Louisiana, United States
Alliance Against Diabetes
🇺🇸Las Vegas, Nevada, United States
Buynak Clinical Research, PC
🇺🇸Valparaiso, Indiana, United States
Planters Clinic
🇺🇸Port Gibson, Mississippi, United States
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Hometown Urgent Care and Research - Huber Heights
🇺🇸Huber Heights, Ohio, United States
Long Island Gastrointestinal Research Group
🇺🇸Great Neck, New York, United States
PMG Research of Rocky Mount
🇺🇸Rocky Mount, North Carolina, United States
Willamette Valley Clinical Studies
🇺🇸Eugene, Oregon, United States
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Juno Research, LLC-Katy
🇺🇸Katy, Texas, United States
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
MD Studies, Inc.
🇺🇸Fountain Valley, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
SRSD, Inc. dba Synergy San Diego
🇺🇸National City, California, United States
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
SDS Clinical Trials, Inc.
🇺🇸Orange, California, United States
Syrentis Clinical Research (formerly Research Across America)
🇺🇸Santa Ana, California, United States
AMR Sakeena Research
🇺🇸Aurora, Illinois, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
The Iowa Clinic; Cardiovascular Services
🇺🇸West Des Moines, Iowa, United States
Otrimed
🇺🇸Edgewood, Kentucky, United States
Great Lakes Medical Research
🇺🇸Westfield, New York, United States
Mid-Hudson Medical Research, PLLC
🇺🇸Hopewell Junction, New York, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
PMG Research of Salisbury, LLC
🇺🇸Salisbury, North Carolina, United States
Sterling Research Group, Ltd
🇺🇸Cincinnati, Ohio, United States
Metabolic Atherosclerosis Research Center
🇺🇸Cincinnati, Ohio, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health
🇺🇸Columbus, Ohio, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
RAS Health LTD
🇺🇸Marion, Ohio, United States
Trinity Universal Research Associates, Inc.
🇺🇸Carrollton, Texas, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
Summit Reserach Group, LLC
🇺🇸Stow, Ohio, United States
Galenos Research
🇺🇸Dallas, Texas, United States
Clinical Trial Network - Houston
🇺🇸Houston, Texas, United States
Burke Internal Medicine & Research
🇺🇸Burke, Virginia, United States
Universal Research Group, LLC
🇺🇸Tacoma, Washington, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Consano Clinical Research
🇺🇸Shavano Park, Texas, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Triad Clinical Trials LLC
🇺🇸Greensboro, North Carolina, United States
Terence T. Hart, MD
🇺🇸Tuscumbia, Alabama, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Scripps Whittier Diabetes Institute
🇺🇸La Jolla, California, United States
Clinical Trial Investigators
🇺🇸Tustin, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Evanston Premier Healthcare Research LLC
🇺🇸Evanston, Illinois, United States
Brandywine Clinical Research
🇺🇸Downingtown, Pennsylvania, United States
Trinity Clinical Research
🇺🇸Tullahoma, Tennessee, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Texas Diabetes Institute Research Center
🇺🇸San Antonio, Texas, United States
Center for Clinical Trials of Sacramento
🇺🇸Sacramento, California, United States
Center for Clinical Trials of Scaramento
🇺🇸Sacramento, California, United States
Superior Research LLC
🇺🇸Sacramento, California, United States
Creekside Endocrine Associates
🇺🇸Denver, Colorado, United States
Clinical Neuroscience Solutions, Inc. Healthcare Orlando
🇺🇸Orlando, Florida, United States
Clinical Reserch Trials of Florida
🇺🇸Tampa, Florida, United States
Meridien Research - Tampa
🇺🇸Tampa, Florida, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
🇺🇸Louisville, Kentucky, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Heartland Clinical Research
🇺🇸Omaha, Nebraska, United States
Medical Research South, LLC
🇺🇸Charleston, South Carolina, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
Kentucky Diabetes Endocrinology Center
🇺🇸Lexington, Kentucky, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Advanced Metabolic Care & Research Institute (AMCR)
🇺🇸Escondido, California, United States
Beacon Clinical Research
🇺🇸Quincy, Massachusetts, United States