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

2018年3月27日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

571

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：600 mg Met DR qAM
600 mg metformin delayed-release once daily in the morning
药品：遇见DR
二甲双胍缓释片
实验性的：900 mg Met DR qAM
900 mg metformin delayed-release once daily in the morning
药品：遇见DR
二甲双胍缓释片
实验性的：1200 mg Met DR qAM
1200 mg metformin delayed-release once daily in the morning
药品：遇见DR
二甲双胍缓释片
实验性的：1500 mg Met DR qAM
1500 mg metformin delayed-release once daily in the morning
药品：遇见DR
二甲双胍缓释片
安慰剂比较：Placebo-1
placebo match for 600 and 1200 mg Met DR qAM treatment groups
药品：安慰剂
安慰剂比较：Placebo-2
placebo match for 900 and 1500 mg Met DR qAM treatment groups
药品：安慰剂
有源比较器：2000 mg Met IR
1000 mg metformin immediate-release twice daily
药品：Met IR
metformin immediate-release tablets

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change in HbA1c (%) at 16 Weeks
大体时间：Baseline and 16 weeks after the first dose of study medication
Baseline and 16 weeks after the first dose of study medication

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Elcelyx Therapeutics, Inc.

调查人员

  • 首席研究员：Juan P Frias, MD、National Research Institute - Wilshire

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年9月1日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2016年9月1日

研究注册日期

首次提交

2015年8月16日

首先提交符合 QC 标准的

2015年8月17日

首次发布 (估计)

2015年8月18日

研究记录更新

最后更新发布 (实际的)

2018年4月27日

上次提交的符合 QC 标准的更新

2018年3月27日

最后验证

2018年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LCRM112

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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