이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2018년 3월 27일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

571

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Alabama
      • Anniston, Alabama, 미국, 36207
        • Pinnacle Research Group, LLC
      • Birmingham, Alabama, 미국, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, 미국, 35216
        • Achieve Clinical Research, LLC
      • Birmingham, Alabama, 미국, 35209
        • Central Alabama Research
      • Tuscumbia, Alabama, 미국, 35674
        • Terence T. Hart, MD
    • Arizona
      • Chandler, Arizona, 미국, 85224
        • Radiant Research - Phoenix
      • Glendale, Arizona, 미국, 85306
        • Arrowhead Health Centers
      • Peoria, Arizona, 미국, 85381
        • Holland Center for Family Health, LTD
      • Phoenix, Arizona, 미국, 85018
        • Elite Clinical Studies
      • Phoenix, Arizona, 미국, 85037
        • Thunderbird Internal Medicine - Indian School Rd.
      • Surprise, Arizona, 미국, 85374
        • Clinical Research Institute of Arizona, LLC
    • Arkansas
      • Fayetteville, Arkansas, 미국, 72703
        • Summit Clinical Trials Center
      • Searcy, Arkansas, 미국, 72143
        • Searcy Medical Center
    • California
      • Escondido, California, 미국, 92025
        • Advanced Metabolic Care & Research Institute (AMCR)
      • Fountain Valley, California, 미국, 92708
        • MD Studies, Inc.
      • Huntington Park, California, 미국, 90255
        • National Research Institute
      • La Jolla, California, 미국, 92037
        • Scripps Whittier Diabetes Institute
      • Lincoln, California, 미국, 95648
        • Clinical Trials Research
      • Long Beach, California, 미국, 90806
        • Collaborative Neuroscience Network, LLC
      • Los Angeles, California, 미국, 90057
        • National Research Institute
      • Montclair, California, 미국, 91763
        • Catalina Research Institute
      • National City, California, 미국, 91950
        • SRSD, Inc. dba Synergy San Diego
      • North Hollywood, California, 미국, 91606
        • Providence Clinical Research
      • Oakland, California, 미국, 94607
        • Pacific Research Partners, LLC
      • Orange, California, 미국, 92868
        • SDS Clinical Trials, Inc.
      • Sacramento, California, 미국, 95825
        • Superior Research LLC
      • Sacramento, California, 미국, 95823
        • Center for Clinical Trials of Sacramento
      • Sacramento, California, 미국, 95823
        • Center for Clinical Trials of Scaramento
      • Santa Ana, California, 미국, 92705
        • Syrentis Clinical Research (formerly Research Across America)
      • Spring Valley, California, 미국, 91978
        • Encompass Clinical Research
      • Tustin, California, 미국, 92780
        • Clinical Trial Investigators
      • Van Nuys, California, 미국, 91405
        • Infosphere Clinical Research
    • Colorado
      • Colorado Springs, Colorado, 미국, 80906
        • Colorado Springs Health Partners
      • Denver, Colorado, 미국, 80209
        • Creekside Endocrine Associates
    • Florida
      • Brooksville, Florida, 미국, 34601
        • Meridien Research - Brooksville
      • Cooper City, Florida, 미국, 33024
        • ALL Medical Research, LLC
      • Hialeah, Florida, 미국, 33012
        • Neostart Corporation dba AGA Clinical Trials
      • Jacksonville, Florida, 미국, 32277
        • Care Partners Clinical Research
      • Jupiter, Florida, 미국, 33458
        • Health Awareness, Inc.
      • Kissimmee, Florida, 미국, 34741
        • Family Health Care Clinical Studies
      • Lakeland, Florida, 미국, 33810
        • Clinical Research of Central Florida-Lakeland
      • Miami, Florida, 미국, 33014
        • Clinical Pharmacology of Miami, Inc.
      • Miami, Florida, 미국, 33173
        • Tellus Clinical Research, Inc.
      • Miami, Florida, 미국, 33183
        • Internal Research Associates LLC - Breton
      • Orlando, Florida, 미국, 32801
        • Clinical Neuroscience Solutions, Inc. Healthcare Orlando
      • Ormond Beach, Florida, 미국, 32174
        • Ormond Medical Arts Pharmaceutical Research Center
      • Pembroke Pines, Florida, 미국, 33026
        • Private Practice - Andres Patron, DO
      • Port Orange, Florida, 미국, 32127
        • Progressive Medical Research
      • Saint Petersburg, Florida, 미국, 33709
        • Meridien Reserach - St. Petersburg
      • Tampa, Florida, 미국, 33634
        • Meridien Research - Tampa
      • Tampa, Florida, 미국, 33607
        • Clinical Reserch Trials of Florida
      • West Palm Beach, Florida, 미국, 33401
        • Metabolic Research Institute, Inc.
    • Illinois
      • Addison, Illinois, 미국, 60101
        • Biofortis, Inc.
      • Aurora, Illinois, 미국, 60506
        • AMR Sakeena Research
      • Chicago, Illinois, 미국, 60607
        • Cedar-Crosse Research Center
      • Evanston, Illinois, 미국, 60201
        • Evanston Premier Healthcare Research LLC
    • Indiana
      • Valparaiso, Indiana, 미국, 46383
        • Buynak Clinical Research, PC
    • Iowa
      • West Des Moines, Iowa, 미국, 50266
        • The Iowa Clinic; Cardiovascular Services
    • Kansas
      • Augusta, Kansas, 미국, 67010
        • Heartland Research Associates, LLC - Augusta
      • Topeka, Kansas, 미국, 66606
        • Cotton-O'Neil Clinical Research Center
    • Kentucky
      • Edgewood, Kentucky, 미국, 41017
        • Otrimed
      • Lexington, Kentucky, 미국, 40503
        • Kentucky Diabetes Endocrinology Center
      • Louisville, Kentucky, 미국, 40213
        • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
      • Paducah, Kentucky, 미국, 42003
        • Four Rivers Clinical Research
    • Louisiana
      • Crowley, Louisiana, 미국, 70526
        • Avant Research Associates
      • Lake Charles, Louisiana, 미국, 70601
        • Centex Studies, Inc. - Lake Charles
    • Maryland
      • Columbia, Maryland, 미국, 21045
        • Columbia Medical Practice
      • Hyattsville, Maryland, 미국, 20782
        • Medstar Health Research Institute
      • Oxon Hill, Maryland, 미국, 20745
        • MD Medical Research
    • Massachusetts
      • Quincy, Massachusetts, 미국, 02169
        • Beacon Clinical Research
    • Minnesota
      • Edina, Minnesota, 미국, 55435
        • Radiant Research - Edina
    • Mississippi
      • Port Gibson, Mississippi, 미국, 39150
        • Planters Clinic
    • Montana
      • Butte, Montana, 미국, 59701
        • Mercury Street Medical Group, PLLC
    • Nebraska
      • Omaha, Nebraska, 미국, 68114
        • Quality Clinical Research, Inc.
      • Omaha, Nebraska, 미국, 68134
        • Heartland Clinical Research
    • Nevada
      • Las Vegas, Nevada, 미국, 89119
        • AB Clinical Trials
      • Las Vegas, Nevada, 미국, 89101
        • Alliance Against Diabetes
      • Las Vegas, Nevada, 미국, 89128
        • Palm Medical Research
      • Las Vegas, Nevada, 미국, 89146
        • Ingham Neuroscience Group, LLC
    • New Jersey
      • Berlin, New Jersey, 미국, 08009
        • Comprehensive Clinical Research
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87109
        • Albuquerque Neuroscience, Inc.
      • Albuquerque, New Mexico, 미국, 87102
        • Albuquerque Clinical Trials
    • New York
      • Brooklyn, New York, 미국, 11235
        • NY Scientific
      • Great Neck, New York, 미국, 11023
        • Long Island Gastrointestinal Research Group
      • Hopewell Junction, New York, 미국, 12533
        • Mid-Hudson Medical Research, PLLC
      • Westfield, New York, 미국, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Greensboro, North Carolina, 미국, 27408
        • PharmQuest
      • Greensboro, North Carolina, 미국, 27410
        • Triad Clinical Trials LLC
      • Rocky Mount, North Carolina, 미국, 27804
        • PMG Research of Rocky Mount
      • Salisbury, North Carolina, 미국, 28144
        • PMG Research of Salisbury, LLC
      • Wilmington, North Carolina, 미국, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Cincinnati, Ohio, 미국, 45242
        • New Horizons Clinical Research
      • Cincinnati, Ohio, 미국, 45219
        • Sterling Research Group, Ltd
      • Cincinnati, Ohio, 미국, 45227
        • Metabolic Atherosclerosis Research Center
      • Columbus, Ohio, 미국, 43214
        • Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health
      • Franklin, Ohio, 미국, 45005
        • Prestige Clinical Research
      • Huber Heights, Ohio, 미국, 45424
        • Hometown Urgent Care and Research - Huber Heights
      • Marion, Ohio, 미국, 43302
        • RAS Health LTD
      • Stow, Ohio, 미국, 44224
        • Summit Reserach Group, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73103
        • COR Clinical Research, LLC
    • Oregon
      • Eugene, Oregon, 미국, 97404
        • Willamette Valley Clinical Studies
    • Pennsylvania
      • Downingtown, Pennsylvania, 미국, 19335
        • Brandywine Clinical Research
    • South Carolina
      • Charleston, South Carolina, 미국, 29407
        • Medical Research South, LLC
      • Greer, South Carolina, 미국, 29651
        • Mountain View CLinical Research - Greer
      • Mount Pleasant, South Carolina, 미국, 29464
        • PMG of Charleston, LLC
      • Myrtle Beach, South Carolina, 미국, 29588
        • Family Medicine of SayeBrook, LLC
      • Simpsonville, South Carolina, 미국, 29681
        • Hillcrest Clinical Research, LLC
      • Spartanburg, South Carolina, 미국, 29303
        • Spartanburg Medical Research
      • Spartanburg, South Carolina, 미국, 29301
        • Palmetto Proactive Healthcare, LLC
      • Summerville, South Carolina, 미국, 29485
        • Palmetto Clinical Research
    • Tennessee
      • Bristol, Tennessee, 미국, 37620
        • PMG Research of Bristol, LC - State
      • Knoxville, Tennessee, 미국, 37912
        • PMG Research of Knoxville
      • Memphis, Tennessee, 미국, 38119
        • Clinical Neuroscience Solutions, Inc. - Memphis
      • Tullahoma, Tennessee, 미국, 37388
        • Trinity Clinical Research
    • Texas
      • Austin, Texas, 미국, 78705
        • Central Texas Clinical Research
      • Carrollton, Texas, 미국, 75007
        • Trinity Universal Research Associates, Inc.
      • Dallas, Texas, 미국, 75230
        • Dallas Diabetes and Endocrine Center
      • Dallas, Texas, 미국, 75231
        • Research Institute of Dallas
      • Dallas, Texas, 미국, 75251
        • Galenos Research
      • Houston, Texas, 미국, 77058
        • Centex Studies, Inc.
      • Houston, Texas, 미국, 77036
        • Pioneer Research Solutions, Inc.
      • Houston, Texas, 미국, 77074
        • Clinical Trial Network - Houston
      • Houston, Texas, 미국, 77074
        • Juno Research, LLC-Houston
      • Katy, Texas, 미국, 77450
        • Juno Research, LLC-Katy
      • San Antonio, Texas, 미국, 78215
        • Sun Research Institute
      • San Antonio, Texas, 미국, 78231
        • Victorium Clinical Research
      • San Antonio, Texas, 미국, 78207
        • Texas Diabetes Institute Research Center
      • Shavano Park, Texas, 미국, 78231
        • Consano Clinical Research
      • Sugar Land, Texas, 미국, 77478
        • Southwest Health Associates, P.A.
    • Utah
      • Saint George, Utah, 미국, 84790
        • Chrysalis Clinical Research
    • Virginia
      • Burke, Virginia, 미국, 22015
        • Burke Internal Medicine & Research
      • Manassas, Virginia, 미국, 20110
        • Manassas Clinical Research Center
      • Richmond, Virginia, 미국, 23235
        • Clinical Research Partners, LLC
    • Washington
      • Tacoma, Washington, 미국, 98405
        • Universal Research Group, LLC
  • 푸에르토 리코
      • Carolina, 푸에르토 리코, 00987
        • Puerto Rico Renal and Health Research, Inc.
      • Cidra, 푸에르토 리코, 00736
        • Advanced Medical Concepts
      • Manati, 푸에르토 리코, 00674
        • Manati Center for Clinical Reserach Doctor's Center Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

25년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Is at least 25 years old at Visit 1 (Screening).

  2. Is male, or is female and meets all of the following criteria:

    1. Not breastfeeding
    2. Negative pregnancy test result at Visit 1 (not applicable to post-menopausal or surgically sterile females)
    3. 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.
  3. Body mass index (BMI) 20.0 to 45.0 kg/m² (inclusive) at Visit 1 (Screening).
  4. Has a physical examination with no clinically significant abnormalities as judged by the investigator.
  5. Has T2DM and an HbA1c of 7.5% to 10.5%, inclusive, at Visit 1.
  6. 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.

  7. 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:

    1. Thiazolidinedione, sulfonylurea, dipeptidyl peptidase-4 inhibitors, and alpha-glucosidase inhibitors
    2. Hormone replacement therapy (female subjects) and testosterone (male subjects)
    3. Oral contraceptives (female subjects)
    4. Antihypertensive agents
    5. Lipid-lowering agents
    6. Thyroid replacement therapy
    7. Antidepressant agents
  8. Ability to understand and willingness to adhere to protocol requirements.

Exclusion Criteria:

  1. 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:

    1. Hepatic disease
    2. Gastrointestinal disease
    3. Endocrine disorder (T2DM is allowed)
    4. Cardiovascular disease
    5. Central nervous system diseases
    6. Psychiatric or neurological disorders
    7. Organ transplantation
    8. Chronic or acute infection
    9. Orthostatic hypotension, fainting spells or blackouts
    10. Allergy or hypersensitivity.
  2. A history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within the past year.
  3. Prior major surgery of any kind within 6 months of Visit 1.
  4. A history of >3% weight change within 3 months of Visit 1.
  5. 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.
  6. An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN.
  7. A physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study.

  8. Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications:

    1. Metformin within 2 months of Visit 1 (Screening)
    2. Insulin within 2 weeks of Visit 1 (Screening) or for more than 1 week within 3 months of Visit 1 (Screening)
    3. Glucagon-like peptide-1 receptor agonists or sodium-glucose co-transporter 2 inhibitors within 3 months of Visit 1
    4. Drugs known to affect body weight, including prescription medications and over-the-counter anti obesity agents within 3 months of Visit 1.
    5. 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
    6. 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)
    7. Cationic drugs that are eliminated by renal tubular secretion within 1 week of Visit 1.
    8. Iodinated contrast dye within 1 week prior to Visit 1.
    9. 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.
    10. Met DR or double-blind matching placebo for Met DR at any time prior to Visit 1 (Screening)
  9. 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.
  10. 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.
  11. Has known immune system based allergies or hypersensitivity to any component of study treatment. A history of gastrointestinal intolerance to metformin is not exclusionary.
  12. Is employed by Elcelyx Therapeutics, Inc. (that is an employee, contract worker, or designee of the company).
  13. 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
의약품: DR을 만났습니다
메트포르민 지연 방출 정제
실험적: 900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
의약품: DR을 만났습니다
메트포르민 지연 방출 정제
실험적: 1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
의약품: DR을 만났습니다
메트포르민 지연 방출 정제
실험적: 1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
의약품: DR을 만났습니다
메트포르민 지연 방출 정제
위약 비교기: Placebo-1
placebo match for 600 and 1200 mg Met DR qAM treatment groups
의약품: 위약
위약 비교기: Placebo-2
placebo match for 900 and 1500 mg Met DR qAM treatment groups
의약품: 위약
활성 비교기: 2000 mg Met IR
1000 mg metformin immediate-release twice daily
의약품: Met IR
metformin immediate-release tablets

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Change in HbA1c (%) at 16 Weeks
기간: Baseline and 16 weeks after the first dose of study medication
Baseline and 16 weeks after the first dose of study medication

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Elcelyx Therapeutics, Inc.

수사관

  • 수석 연구원: Juan P Frias, MD, National Research Institute - Wilshire

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 9월 1일

기본 완료 (실제)

2016년 9월 1일

연구 완료 (실제)

2016년 9월 1일

연구 등록 날짜

최초 제출

2015년 8월 16일

QC 기준을 충족하는 최초 제출

2015년 8월 17일

처음 게시됨 (추정)

2015년 8월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 4월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 3월 27일

마지막으로 확인됨

2018년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • LCRM112

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

제2형 당뇨병에 대한 임상 시험

위약에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Djibouti

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다