Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM
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
1 other identifier
interventional
571
2 countries
137
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Sep 2015
137 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
April 27, 2018
CompletedApril 27, 2018
March 1, 2018
1 year
August 16, 2015
March 27, 2018
March 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c (%) at 16 Weeks
Baseline and 16 weeks after the first dose of study medication
Study Arms (7)
600 mg Met DR qAM
EXPERIMENTAL600 mg metformin delayed-release once daily in the morning
900 mg Met DR qAM
EXPERIMENTAL900 mg metformin delayed-release once daily in the morning
1200 mg Met DR qAM
EXPERIMENTAL1200 mg metformin delayed-release once daily in the morning
1500 mg Met DR qAM
EXPERIMENTAL1500 mg metformin delayed-release once daily in the morning
Placebo-1
PLACEBO COMPARATORplacebo match for 600 and 1200 mg Met DR qAM treatment groups
Placebo-2
PLACEBO COMPARATORplacebo match for 900 and 1500 mg Met DR qAM treatment groups
2000 mg Met IR
ACTIVE COMPARATOR1000 mg metformin immediate-release twice daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (137)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Central Alabama Research
Birmingham, Alabama, 35209, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Terence T. Hart, MD
Tuscumbia, Alabama, 35674, United States
Radiant Research - Phoenix
Chandler, Arizona, 85224, United States
Arrowhead Health Centers
Glendale, Arizona, 85306, United States
Holland Center for Family Health, LTD
Peoria, Arizona, 85381, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Thunderbird Internal Medicine - Indian School Rd.
Phoenix, Arizona, 85037, United States
Clinical Research Institute of Arizona, LLC
Surprise, Arizona, 85374, United States
Summit Clinical Trials Center
Fayetteville, Arkansas, 72703, United States
Searcy Medical Center
Searcy, Arkansas, 72143, United States
Advanced Metabolic Care & Research Institute (AMCR)
Escondido, California, 92025, United States
MD Studies, Inc.
Fountain Valley, California, 92708, United States
National Research Institute
Huntington Park, California, 90255, United States
Scripps Whittier Diabetes Institute
La Jolla, California, 92037, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
National Research Institute
Los Angeles, California, 90057, United States
Catalina Research Institute
Montclair, California, 91763, United States
SRSD, Inc. dba Synergy San Diego
National City, California, 91950, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
Pacific Research Partners, LLC
Oakland, California, 94607, United States
SDS Clinical Trials, Inc.
Orange, California, 92868, United States
Center for Clinical Trials of Sacramento
Sacramento, California, 95823, United States
Center for Clinical Trials of Scaramento
Sacramento, California, 95823, United States
Superior Research LLC
Sacramento, California, 95825, United States
Syrentis Clinical Research (formerly Research Across America)
Santa Ana, California, 92705, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Clinical Trial Investigators
Tustin, California, 92780, United States
Infosphere Clinical Research
Van Nuys, California, 91405, United States
Colorado Springs Health Partners
Colorado Springs, Colorado, 80906, United States
Creekside Endocrine Associates
Denver, Colorado, 80209, United States
Meridien Research - Brooksville
Brooksville, Florida, 34601, United States
ALL Medical Research, LLC
Cooper City, Florida, 33024, United States
Neostart Corporation dba AGA Clinical Trials
Hialeah, Florida, 33012, United States
Care Partners Clinical Research
Jacksonville, Florida, 32277, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Family Health Care Clinical Studies
Kissimmee, Florida, 34741, United States
Clinical Research of Central Florida-Lakeland
Lakeland, Florida, 33810, United States
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014, United States
Tellus Clinical Research, Inc.
Miami, Florida, 33173, United States
Internal Research Associates LLC - Breton
Miami, Florida, 33183, United States
Clinical Neuroscience Solutions, Inc. Healthcare Orlando
Orlando, Florida, 32801, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174, United States
Private Practice - Andres Patron, DO
Pembroke Pines, Florida, 33026, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Meridien Reserach - St. Petersburg
St. Petersburg, Florida, 33709, United States
Clinical Reserch Trials of Florida
Tampa, Florida, 33607, United States
Meridien Research - Tampa
Tampa, Florida, 33634, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Biofortis, Inc.
Addison, Illinois, 60101, United States
AMR Sakeena Research
Aurora, Illinois, 60506, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201, United States
Buynak Clinical Research, PC
Valparaiso, Indiana, 46383, United States
The Iowa Clinic; Cardiovascular Services
West Des Moines, Iowa, 50266, United States
Heartland Research Associates, LLC - Augusta
Augusta, Kansas, 67010, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Otrimed
Edgewood, Kentucky, 41017, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, 40503, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, 40213, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
Avant Research Associates
Crowley, Louisiana, 70526, United States
Centex Studies, Inc. - lake Charles
Lake Charles, Louisiana, 70601, United States
Columbia Medical Practice
Columbia, Maryland, 21045, United States
Medstar Health Research Institute
Hyattsville, Maryland, 20782, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
Beacon Clinical Research
Quincy, Massachusetts, 02169, United States
Radiant Research - Edina
Edina, Minnesota, 55435, United States
Planters Clinic
Port Gibson, Mississippi, 39150, United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Heartland Clinical Research
Omaha, Nebraska, 68134, United States
Alliance Against Diabetes
Las Vegas, Nevada, 89101, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
Palm Medical Research
Las Vegas, Nevada, 89128, United States
Ingham Neuroscience Group, LLC
Las Vegas, Nevada, 89146, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, United States
NY Scientific
Brooklyn, New York, 11235, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
Mid-Hudson Medical Research, PLLC
Hopewell Junction, New York, 12533, United States
Great Lakes Medical Research
Westfield, New York, 14787, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
Triad Clinical Trials LLC
Greensboro, North Carolina, 27410, United States
PMG Research of Rocky Mount
Rocky Mount, North Carolina, 27804, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Sterling Research Group, Ltd
Cincinnati, Ohio, 45219, United States
Metabolic Atherosclerosis Research Center
Cincinnati, Ohio, 45227, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health
Columbus, Ohio, 43214, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Hometown Urgent Care and Research - Huber Heights
Huber Heights, Ohio, 45424, United States
RAS Health LTD
Marion, Ohio, 43302, United States
Summit Reserach Group, LLC
Stow, Ohio, 44224, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335, United States
Medical Research South, LLC
Charleston, South Carolina, 29407, United States
Mountain View Clinical Research - Greer
Greer, South Carolina, 29651, United States
PMG of Charleston, LLC
Mt. Pleasant, South Carolina, 29464, United States
Family Medicine of SayeBrook, LLC
Myrtle Beach, South Carolina, 29588, United States
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, 29681, United States
Palmetto Proactive Healthcare, LLC
Spartanburg, South Carolina, 29301, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
PMG Research of Bristol, LC - State
Bristol, Tennessee, 37620, United States
PMG Research of Knoxville
Knoxville, Tennessee, 37912, United States
Clinical Neuroscience Solutions, Inc. - Memphis
Memphis, Tennessee, 38119, United States
Trinity Clinical Research
Tullahoma, Tennessee, 37388, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Trinity Universal Research Associates, Inc.
Carrollton, Texas, 75007, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230, United States
Research Institute of Dallas
Dallas, Texas, 75231, United States
Galenos Research
Dallas, Texas, 75251, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77036, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
Clinical Trial Network - Houston
Houston, Texas, 77074, United States
Juno Research, LLC-Houston
Houston, Texas, 77074, United States
Juno Research, LLC-Katy
Katy, Texas, 77450, United States
Texas Diabetes Institute Research Center
San Antonio, Texas, 78207, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Victorium Clinical Research
San Antonio, Texas, 78231, United States
Consano Clinical Research
Shavano Park, Texas, 78231, United States
Southwest Health Associates, P.A.
Sugar Land, Texas, 77478, United States
Chrysalis Clinical Research
St. George, Utah, 84790, United States
Burke Internal Medicine & Research
Burke, Virginia, 22015, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23235, United States
Universal Research Group, LLC
Tacoma, Washington, 98405, United States
Puerto Rico Renal and Health Research, Inc.
Carolina, 00987, Puerto Rico
Advanced Medical Concepts
Cidra, 00736, Puerto Rico
Manati Center for Clinical Reserach Doctor's Center Hospital
ManatÃ, 00674, Puerto Rico
Related Publications (1)
Henry RR, Frias JP, Walsh B, Skare S, Hemming J, Burns C, Bicsak TA, Baron A, Fineman M. Improved glycemic control with minimal systemic metformin exposure: Effects of Metformin Delayed-Release (Metformin DR) targeting the lower bowel over 16 weeks in a randomized trial in subjects with type 2 diabetes. PLoS One. 2018 Sep 25;13(9):e0203946. doi: 10.1371/journal.pone.0203946. eCollection 2018.
PMID: 30252913DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Scientific Officer
- Organization
- Elcelyx Therapeutics, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Juan P Frias, MD
National Research Institute - Wilshire
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2015
First Posted
August 18, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
April 27, 2018
Results First Posted
April 27, 2018
Record last verified: 2018-03