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Type 2 Diabetes MellitusPhase 2NCT02526524

Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM

A Phase 2 study testing Met DR and Met IR in people with Type 2 Diabetes Mellitus, run by Elcelyx Therapeutics, Inc. at 137 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Met DR and Met IR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
571 participants
Where
137 sitesin 2 countries
Study dates
Sep 2015to Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 18Show fewer
  • 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.

Who cannot join

  • 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
Show all 33Show fewer
  • 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.

Trial locations and contacts

137 sites in 2 countries.

137 sites in 2 countries

United States134 sites

  • Biofortis, Inc.

    Addison, Illinois, 60101

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico, 87109

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Heartland Research Associates, LLC - Augusta

    Augusta, Kansas, 67010

  • AMR Sakeena Research

    Aurora, Illinois, 60506

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • PMG Research of Bristol, LC - State

    Bristol, Tennessee, 37620

  • NY Scientific

    Brooklyn, New York, 11235

  • Meridien Research - Brooksville

    Brooksville, Florida, 34601

  • Burke Internal Medicine & Research

    Burke, Virginia, 22015

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

  • Trinity Universal Research Associates, Inc.

    Carrollton, Texas, 75007

  • Radiant Research - Phoenix

    Chandler, Arizona, 85224

  • Medical Research South, LLC

    Charleston, South Carolina, 29407

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Sterling Research Group, Ltd

    Cincinnati, Ohio, 45219

  • Metabolic Atherosclerosis Research Center

    Cincinnati, Ohio, 45227

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Colorado Springs Health Partners

    Colorado Springs, Colorado, 80906

  • Columbia Medical Practice

    Columbia, Maryland, 21045

  • Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health

    Columbus, Ohio, 43214

  • ALL Medical Research, LLC

    Cooper City, Florida, 33024

  • Avant Research Associates

    Crowley, Louisiana, 70526

  • Dallas Diabetes and Endocrine Center

    Dallas, Texas, 75230

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Galenos Research

    Dallas, Texas, 75251

  • Creekside Endocrine Associates

    Denver, Colorado, 80209

  • Brandywine Clinical Research

    Downingtown, Pennsylvania, 19335

  • Otrimed

    Edgewood, Kentucky, 41017

  • Radiant Research - Edina

    Edina, Minnesota, 55435

  • Advanced Metabolic Care & Research Institute (AMCR)

    Escondido, California, 92025

  • Willamette Valley Clinical Studies

    Eugene, Oregon, 97404

  • Evanston Premier Healthcare Research LLC

    Evanston, Illinois, 60201

  • Summit Clinical Trials Center

    Fayetteville, Arkansas, 72703

  • MD Studies, Inc.

    Fountain Valley, California, 92708

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Arrowhead Health Centers

    Glendale, Arizona, 85306

  • Long Island Gastrointestinal Research Group

    Great Neck, New York, 11023

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Triad Clinical Trials LLC

    Greensboro, North Carolina, 27410

  • Mountain View Clinical Research - Greer

    Greer, South Carolina, 29651

  • Neostart Corporation dba AGA Clinical Trials

    Hialeah, Florida, 33012

  • Mid-Hudson Medical Research, PLLC

    Hopewell Junction, New York, 12533

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77036

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Clinical Trial Network - Houston

    Houston, Texas, 77074

  • Juno Research, LLC-Houston

    Houston, Texas, 77074

  • Hometown Urgent Care and Research - Huber Heights

    Huber Heights, Ohio, 45424

  • National Research Institute

    Huntington Park, California, 90255

  • Medstar Health Research Institute

    Hyattsville, Maryland, 20782

  • Care Partners Clinical Research

    Jacksonville, Florida, 32277

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Juno Research, LLC-Katy

    Katy, Texas, 77450

  • Family Health Care Clinical Studies

    Kissimmee, Florida, 34741

  • PMG Research of Knoxville

    Knoxville, Tennessee, 37912

  • Scripps Whittier Diabetes Institute

    La Jolla, California, 92037

  • Centex Studies, Inc. - lake Charles

    Lake Charles, Louisiana, 70601

  • Clinical Research of Central Florida-Lakeland

    Lakeland, Florida, 33810

  • Alliance Against Diabetes

    Las Vegas, Nevada, 89101

  • AB Clinical Trials

    Las Vegas, Nevada, 89119

  • Palm Medical Research

    Las Vegas, Nevada, 89128

  • Ingham Neuroscience Group, LLC

    Las Vegas, Nevada, 89146

  • Kentucky Diabetes Endocrinology Center

    Lexington, Kentucky, 40503

  • Clinical Trials Research

    Lincoln, California, 95648

  • Collaborative Neuroscience Network, LLC

    Long Beach, California, 90806

  • National Research Institute

    Los Angeles, California, 90057

  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky, 40213

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • RAS Health LTD

    Marion, Ohio, 43302

  • Clinical Neuroscience Solutions, Inc. - Memphis

    Memphis, Tennessee, 38119

  • Clinical Pharmacology of Miami, Inc.

    Miami, Florida, 33014

  • Tellus Clinical Research, Inc.

    Miami, Florida, 33173

  • Internal Research Associates LLC - Breton

    Miami, Florida, 33183

  • Catalina Research Institute

    Montclair, California, 91763

  • PMG of Charleston, LLC

    Mt. Pleasant, South Carolina, 29464

  • Family Medicine of SayeBrook, LLC

    Myrtle Beach, South Carolina, 29588

  • SRSD, Inc. dba Synergy San Diego

    National City, California, 91950

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Pacific Research Partners, LLC

    Oakland, California, 94607

  • COR Clinical Research, LLC

    Oklahoma City, Oklahoma, 73103

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Heartland Clinical Research

    Omaha, Nebraska, 68134

  • SDS Clinical Trials, Inc.

    Orange, California, 92868

  • Clinical Neuroscience Solutions, Inc. Healthcare Orlando

    Orlando, Florida, 32801

  • Ormond Medical Arts Pharmaceutical Research Center

    Ormond Beach, Florida, 32174

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Four Rivers Clinical Research

    Paducah, Kentucky, 42003

  • Private Practice - Andres Patron, DO

    Pembroke Pines, Florida, 33026

  • Holland Center for Family Health, LTD

    Peoria, Arizona, 85381

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Thunderbird Internal Medicine - Indian School Rd.

    Phoenix, Arizona, 85037

  • Planters Clinic

    Port Gibson, Mississippi, 39150

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Beacon Clinical Research

    Quincy, Massachusetts, 02169

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23235

  • PMG Research of Rocky Mount

    Rocky Mount, North Carolina, 27804

  • Center for Clinical Trials of Sacramento

    Sacramento, California, 95823

  • Center for Clinical Trials of Scaramento

    Sacramento, California, 95823

  • Superior Research LLC

    Sacramento, California, 95825

  • PMG Research of Salisbury, LLC

    Salisbury, North Carolina, 28144

  • Texas Diabetes Institute Research Center

    San Antonio, Texas, 78207

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Victorium Clinical Research

    San Antonio, Texas, 78231

  • Syrentis Clinical Research (formerly Research Across America)

    Santa Ana, California, 92705

  • Searcy Medical Center

    Searcy, Arkansas, 72143

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • Hillcrest Clinical Research, LLC

    Simpsonville, South Carolina, 29681

  • Palmetto Proactive Healthcare, LLC

    Spartanburg, South Carolina, 29301

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Meridien Reserach - St. Petersburg

    St. Petersburg, Florida, 33709

  • Summit Reserach Group, LLC

    Stow, Ohio, 44224

  • Southwest Health Associates, P.A.

    Sugar Land, Texas, 77478

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Clinical Research Institute of Arizona, LLC

    Surprise, Arizona, 85374

  • Universal Research Group, LLC

    Tacoma, Washington, 98405

  • Clinical Reserch Trials of Florida

    Tampa, Florida, 33607

  • Meridien Research - Tampa

    Tampa, Florida, 33634

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Trinity Clinical Research

    Tullahoma, Tennessee, 37388

  • Terence T. Hart, MD

    Tuscumbia, Alabama, 35674

  • Clinical Trial Investigators

    Tustin, California, 92780

  • Buynak Clinical Research, PC

    Valparaiso, Indiana, 46383

  • Infosphere Clinical Research

    Van Nuys, California, 91405

  • The Iowa Clinic; Cardiovascular Services

    West Des Moines, Iowa, 50266

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • Great Lakes Medical Research

    Westfield, New York, 14787

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

Other trials in United States

Puerto Rico3 sites

  • Puerto Rico Renal and Health Research, Inc.

    Carolina, 00987

  • Advanced Medical Concepts

    Cidra, 00736

  • Manati Center for Clinical Reserach Doctor's Center Hospital

    Manati, 00674

Other trials in Puerto Rico

About this study

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

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.

Being tested
Met DR, Met IR, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Met DRDrug

    metformin delayed-release tablets

  • Met IRDrug

    metformin immediate-release tablets

  • PlaceboDrug

Study groups in NCT02526524
Study groupRoleWhat they receive
600 mg Met DR qAMExperimental600 mg metformin delayed-release once daily in the morning
Receives: Drug: Met DR
900 mg Met DR qAMExperimental900 mg metformin delayed-release once daily in the morning
Receives: Drug: Met DR
1200 mg Met DR qAMExperimental1200 mg metformin delayed-release once daily in the morning
Receives: Drug: Met DR
1500 mg Met DR qAMExperimental1500 mg metformin delayed-release once daily in the morning
Receives: Drug: Met DR
Placebo-1Placebo comparatorplacebo match for 600 and 1200 mg Met DR qAM treatment groups
Receives: Drug: Placebo
Placebo-2Placebo comparatorplacebo match for 900 and 1500 mg Met DR qAM treatment groups
Receives: Drug: Placebo
2000 mg Met IRActive comparator1000 mg metformin immediate-release twice daily
Receives: Drug: Met IR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c (%) at 16 Weeks

    Measured: Baseline and 16 weeks after the first dose of study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
571 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02526524
Sponsor's protocol ID
LCRM112
Status last verified
Mar 2018
First submitted
16 Aug 2015
Last updated
27 Apr 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 30252913

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Met DR and Met IR in people with Type 2 Diabetes Mellitus, run by Elcelyx Therapeutics, Inc. at 137 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (%) at 16 Weeks (time frame: Baseline and 16 weeks after the first dose of study medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02526524, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.

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