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

Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

2014년 10월 15일 업데이트: Gilead Sciences

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when given as monotherapy on glycemic control in subjects with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise alone and who are treatment naive to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days (or thiazolidinediones [TZDs] for at least 24 weeks) prior to screening, and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

465

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 남아프리카
      • Benoni, 남아프리카, 1500
        • Worthwhile Clinical Trials
      • Johannesburg, 남아프리카, 1818
        • Soweto Clinical Trial Centre
      • Johannesburg, 남아프리카, 01829
        • Centre for Diabetes, Asthma and Allergy
      • Kwa Zulu Natal, 남아프리카, 4170
        • Aliwal Shoal Medical & Clinical Trial Centre
      • Pretoria, 남아프리카, 0001
        • Global Clinical Trials
      • Somerset West, 남아프리카, 7130
        • Helderberg Clinical Trials Centre
      • Western Cape, 남아프리카, 7530
        • Tiervlei Trial Centre
    • Durban
      • Newlands West, Durban, 남아프리카, 4037
        • Newkwa Medical Centre
    • Umhlanga, Durban
      • Kwa Zulu Natal, Umhlanga, Durban, 남아프리카, 4320
        • Netcare Umhlanga Medical Centre
  • 러시아 연방
      • Arkhangelskoe, 러시아 연방, 143420
        • 3rd Central Military Clinical Hospital named after A.A.Vishnevskogo
      • Chita, 러시아 연방, 672090
        • GOU VPO "Chita State Medical Academy" of Minzdravsocrazvitie RF
      • Dzerzhinskiy, 러시아 연방, 140091
        • "Clinic of New Medical Technology" Company Limited
      • Ekaterinburg, 러시아 연방, 620102
        • The Urals State Medical Academy
      • Kemerovo, 러시아 연방, 650066
        • Kemerovo Regional Clinical Hospital
      • Krasnoyarsk, 러시아 연방, 660062
        • "Krasnoyarsk State Medical University n.a. Prof. V.F. Voyno-Yasenetsky
      • Moscow, 러시아 연방, 117593
        • Central Clinical Hospital of Russian Academy of Sciences
      • Moscow, 러시아 연방, 117556
        • State Healthcare Institution of Moscow "Cardiologival Dispensary #2 of Management Department of South Administrative District"
      • Moscow, 러시아 연방, 127299
        • Medical Sanitary Unit of Minestry of Internal Affairs of Russia in Moscow
      • Moscow, 러시아 연방, 129090
        • Moscow City Clinical Hospital #63
      • Nizhniy Novgorod, 러시아 연방, 603018
        • City Clinical Hospital # 13 of Avtozavodsky District of Nizhniy Novgorod
      • Novosibirsk, 러시아 연방, 630087
        • Novosibirsk State Medical University
      • Novosibirsk, 러시아 연방, 630117
        • Scientific Research Institute of Physiology of Siberian Department RAMS
      • Novosibirsk, 러시아 연방, 630099
        • LLC "Reafan"
      • Pushkin, 러시아 연방, 196601
        • City Hospital # 38 named after N A Semashko
      • Rostov-on-Don, 러시아 연방, 344022
        • Rostov State Medical University
      • Ryazan, 러시아 연방, 390005
        • Ryazan State Medical University
      • Samara, 러시아 연방, 443067
        • Center "Diabetes", LLC
      • Smolensk, 러시아 연방, 214019
        • Smolensk State Medical Academy, Sanatorium-Preventorium
      • St. Petersburg, 러시아 연방, 190000
        • Medinet, LLC
      • St. Petersburg, 러시아 연방, 191015
        • North-Western State Medical Unversity n.a. I.I.Mechnikov
      • St. Petersburg, 러시아 연방, 191124
        • Military Medical Academy named after S.M. Kirov
      • St. Petersburg, 러시아 연방, 192283
        • Saint-Petersburg state budgetary healthcare institution "City Polyclinic #109"
      • St. Petersburg, 러시아 연방, 193312
        • Alexanders City Hospital
      • St. Petersburg, 러시아 연방, 194291
        • Clinical Hospital #122 n.a. Sokolov of FMBA
      • St. Petersburg, 러시아 연방, 194354
        • ANO "Medical Centre "XXI century"
      • St. Petersburg, 러시아 연방, 195257
        • St. Elizabeth City Hospital
      • St. Petersburg, 러시아 연방, 197042
        • Krestovsky Island Medical Institute, LLC
      • St. Petersburg, 러시아 연방, 197341
        • Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov
      • St. Petersburg, 러시아 연방, 198168
        • International Medical Center "SOGAZ", LLC
      • St. Petersburg, 러시아 연방, 199106
        • Saint-Petersburg City Pokrovskaya Hospital
      • St. Petersburg, 러시아 연방, +011 78123152068
        • Saint-Petersburg City Outpatient Clinic#37
      • St. Petersburg, 러시아 연방, 198013
        • Military Medical Academy named after S.M. Kirov
      • Tyumen, 러시아 연방, 625023
        • Tyumen State Medical Academy
      • Voronezh, 러시아 연방, 394082
        • Voronezh Regional Clinical Hospital #1
      • Yaroslavl, 러시아 연방, 150062
        • Yaroslavl Regional Clinical Hospital
      • Yaroslavl, 러시아 연방, 150002
        • City Hospital named after N.A.Semashko
      • Yaroslavl, 러시아 연방, 150003
        • Clinical Hospital for Emergency Care named after N.V. Solovyov
      • Yaroslavl, 러시아 연방, 150023
        • Medical Sanitary Unit of Novo-Yaroslavsky Oil Refinery
  • 루마니아
      • Bucharest, 루마니아, 020354
        • Tehnomed Trading Srl
      • Bucuresti, 루마니아, 020042
        • Institutul de Diabet, Nutritie si Boli Metabolice "Dr. N. C. Paulescu"
      • Bucuresti, 루마니아, 020725
        • O.D. Medica Srl
      • Timisoara, jud. Timis, 루마니아, 300456
        • Centru Medical Dr. Negrisanu
    • Jud Bihor
      • Oradea, Jud Bihor, 루마니아, 410169
        • Spital Clinic Judetean de Urgenta Oradea Stationarul 1
    • Jud Brasov
      • Brasov, Jud Brasov, 루마니아, 500269
        • Vitadiab SRL - Cabinet Medical Dr. Barabas Alina SRL
    • Jud. Iasi
      • Iasi, Jud. Iasi, 루마니아, 700547
        • Consultmed SRL
    • Jud. Maramures
      • Baia Mare, Jud. Maramures, 루마니아, 430123
        • CMI Diabet Nutritie Boli Metabolice Dr. Pop Lavinia
    • Judetul Galati
      • Galati, Judetul Galati, 루마니아, 800371
        • CMI Morosanu V. Magdalena
      • Galati, Judetul Galati, 루마니아, 800578
        • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati
    • Judetul Prahova
      • Ploiesti, Judetul Prahova, 루마니아, 100163
        • Diabmed Dr. Popescu Alexandrina SRL
  • 미국
    • Arizona
      • Glendale, Arizona, 미국, 85306
        • Thunderbird Internal Medicine/Clinical Research Advantage
      • Phoenix, Arizona, 미국, 85020
        • Central Phoenix Medical Clinic
      • Tucson, Arizona, 미국, 85745
        • Eclipse Clinical Research
      • Tucson, Arizona, 미국, 85710
        • Desert Sun Clinical Research, LLC
    • Arkansas
      • Mountain Home, Arkansas, 미국, 72653
        • North Central Arkansas Medical Associates
      • Pine Bluff, Arkansas, 미국, 71603
        • Paul W. Davis, MD, Private Practice
    • California
      • Fountain Valley, California, 미국, 92708
        • Southland Clinical Research Center, Inc.
      • Glendale, California, 미국, 91205
        • Global Research Management
      • Los Angeles, California, 미국, 90057
        • National Research Institute
      • Moreno Valley, California, 미국, 92553
        • Spectrum Clinical Research Institute, Inc
      • Sacramento, California, 미국, 95825
        • Sacramento Heart And Vascular Medical Associates
      • Santa Clarita, California, 미국, 91350
        • Clearview Medical Research LLC
      • West Hills, California, 미국, 91307
        • Infosphere Clinical Research
    • Florida
      • Boca Raton, Florida, 미국, 33432
        • Boca Raton Clinical Research Associates, Inc
      • Brandon, Florida, 미국, 33511
        • PAB Clinical Research
      • Gainesville, Florida, 미국, 32605-4253
        • Florida Research Network, LLC
      • Hialeah, Florida, 미국, 33012
        • A G A Clinical Trials
      • Jacksonville, Florida, 미국, 32216
        • Jacksonville Center for Clinical Research
      • Miami, Florida, 미국, 33156
        • Baptist Diabetes Associates
      • Miami Beach, Florida, 미국, 33140
        • NextPhase Clinical Trials, Inc.
      • Miami Lakes, Florida, 미국, 33016
        • Precision Research Organization
      • New Port Richey, Florida, 미국, 34652
        • Suncoast Clinical Research
      • Orlando, Florida, 미국, 32822
        • Florida Institute For Clinical Research LLC
      • South Miami, Florida, 미국, 33143
        • Regenerate Clinical Trials
    • Georgia
      • Atlanta, Georgia, 미국, 30127
        • Synergy Therapeutic Partners
    • Idaho
      • Eagle, Idaho, 미국, 83616
        • CTL Research
    • Illinois
      • Chicago, Illinois, 미국, 60607
        • Cedar-Crosse Research Center
    • Indiana
      • Michigan City, Indiana, 미국, 46360
        • LaPorte County Institute for Clinical Research
    • Louisiana
      • Metairie, Louisiana, 미국, 70006
        • Clinical Trials Management, LLC
    • Maryland
      • Oxon Hill, Maryland, 미국, 20745
        • MD Medical Research
      • Towson, Maryland, 미국, 21204
        • IRC Clinics, Inc
    • Michigan
      • Battle Creek, Michigan, 미국, 49015
        • Associated Internal Medicine Specialists, P.C.
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87102
        • Albuquerque Clinical Trials
      • Albuquerque, New Mexico, 미국, 87131
        • University of New Mexico Clinical and Translational Science Center
    • New York
      • New York, New York, 미국, 10016
        • Clinical Research Solution
    • North Carolina
      • Charlotte, North Carolina, 미국, 28202
        • PMG Research of Charlotte
      • Greensboro, North Carolina, 미국, 27408
        • PharmQuest
      • Salisbury, North Carolina, 미국, 28144
        • PMG Research of Salisbury
    • Ohio
      • Beavercreek, Ohio, 미국, 45431
        • Clinical Inquest Center, Ltd.
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73103
        • Infinity Research Group, LLC
    • Pennsylvania
      • Altoona, Pennsylvania, 미국, 16602
        • Blair Medical Associates, Inc, Station Medical Center
    • South Carolina
      • Taylors, South Carolina, 미국, 29687
        • Southeastern Research Associates, Inc.
    • Tennessee
      • Columbia, Tennessee, 미국, 38401
        • HCCA Clinical Research Solutions
      • Jackson, Tennessee, 미국, 38305
        • HCCA Clinical Research Solution
      • Knoxville, Tennessee, 미국, 37923
        • New Phase Research & Development
      • Smyrrna, Tennessee, 미국, 37167
        • HCCA Clinical Research Solutions
    • Texas
      • Dallas, Texas, 미국, 75390
        • The University of Texas Southwestern Medical Center at Dallas
      • Houston, Texas, 미국, 77081
        • Excel Clinical Research, LLC
      • Houston, Texas, 미국, 77081
        • Texas Center for Drug Development, PA
      • Humble, Texas, 미국, 77338
        • Humble Cardiology Associates
      • Katy, Texas, 미국, 77450
        • Juno Research, LLC
      • San Antonio, Texas, 미국, 78258
        • Discovery Clinical Trials
      • San Antonio, Texas, 미국, 78237
        • Cetero Research
    • Utah
      • Salt Lake City, Utah, 미국, 84124
        • Jean Brown Research
      • Salt Lake City, Utah, 미국, 84124
        • Highland Clinical Research
    • Virginia
      • Burke, Virginia, 미국, 22015
        • Burke Internal Medicine & Research
      • Manassas, Virginia, 미국, 20110
        • Manassas Clinical Research Center
  • 세르비아
      • Belgrade, 세르비아, 11000
        • Clinical Center of Serbia
      • Kragujevac, 세르비아, 34000
        • Clinical Center of Kragujevac
  • 슬로바키아
      • Malacky, 슬로바키아, 901 01
        • MediVet s.r.o.
    • Bratislavsky kraj
      • Bratislava, Bratislavsky kraj, 슬로바키아, 831 01
        • Metabolic Center of Dr. Katarina Raslova Ltd.
      • Bratislava, Bratislavsky kraj, 슬로바키아, 811 01
        • METABOLKLINIK s.r.o.
    • Kosicky kraj
      • Kosice, Kosicky kraj, 슬로바키아, 04001
        • "Diabetologicka a metabolicka ambulancia Human-care s.r.o"
      • Trebisov, Kosicky kraj, 슬로바키아, 07501
        • ARETEUS s.r.o., Diabetologicka ambulancia
    • Zilinsky kraj
      • Dolny Kubin, Zilinsky kraj, 슬로바키아, 02601
        • ENDIAMED s.r.o
      • Zilina, Zilinsky kraj, 슬로바키아, 010 10
        • Medivasa s.r.o.
  • 우크라이나
      • Dnipropetrovsk, 우크라이나, 49023
        • City Clinical Hospital#9, Dnipropetrovsk State Medical Academy
      • Donetsk, 우크라이나, 83003
        • Educational Scientific Medical Centre "University clinic" of Donetsk National Medical University n.a. M.Gorkiy
      • Kharkiv, 우크라이나, 61002
        • State Institution "Institute of Problems of Endocrine Pathology n.a. V.Y. Danylevsky of NAMS of Ukraine"
      • Kyiv, 우크라이나, 04050
        • Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
      • Kyiv, 우크라이나, 04050
        • National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clinic # 2 of Shevchenkovsky District
      • Kyiv, 우크라이나, 04114
        • V. P. Komissarenko Institute of Endocrinology and Metabolism of AMS of Ukraine
      • Lutsk, 우크라이나, 43024
        • Municipal Institution Lutsk City Clinical Hospital
      • Lviv, 우크라이나, 79010
        • Lviv Regional Endocrinology Dispensary
      • Odesa, 우크라이나, 65039
        • Odessa State Medical University
      • Odesa, 우크라이나, 65114
        • Public Institution "City Outpatients' Hospital #20"
      • Vinnytsya, 우크라이나, 21010
        • Vinnytsya Regional Clinical Endocrinology Dispensary
      • Zhytomyr, 우크라이나, 10002
        • Zhytomyr Regional Clinical Hospital
  • 체코 공화국
    • Moravskoslezsky kraj
      • Havirov, Moravskoslezsky kraj, 체코 공화국, 736 01
        • Nemocnice s poliklinikou Havirov
  • 폴란드
      • Bialystok, 폴란드, 15-461
        • NZOZ Centrum Osteporozy i Chorob Kostno-Stawowych J.Badurski Sp.j.
      • Chrzanów, 폴란드, 32-500
        • Leszek Romanowski Barbara Romanowska "DIABET" Centrum Medyczne s.c.
      • Krakow, 폴란드, 31-159
        • NZOZ Specjalistyczna Przychodnia Medyczna Atopia
      • Lodz, 폴란드, 92-003
        • NZOZ Cereo-Med Sp. z o.o.
      • Ostroda, 폴란드, 14-100
        • Specjalistyzny Ośrodek Lecznicz-Badawczy
      • Warszawa, 폴란드, 04-749
        • Miedzyleski Szpital Specjalistyczny w Warszawie
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, 폴란드, 50-349
        • NZOZ Centrum Badan Klinicznych
      • Wroclaw, Dolnoslaskie, 폴란드, 50-127
        • NZOZ Regionalna Poradnia Diabetologiczna
    • Lodzkie
      • Lodz, Lodzkie, 폴란드, 90-302
        • NZOZ Centrum Medyczne Szpital Sw. Rodziny
      • Lodz, Lodzkie, 폴란드, 90-153
        • SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi, Oddział Kliniczny Diabetologii
      • Zgierz, Lodzkie, 폴란드, 95-100
        • NZOZ Polimedica
    • Malopolskie
      • Krakow, Malopolskie, 폴란드, 30-015
        • LANDA - Specjalistyczne Gabinety Lekarskie
      • Oswięcim, Malopolskie, 폴란드, 32-600
        • NZOZ Centrum Badan Klinicznych Oswiecim
    • Swietokrzyskie
      • Kielce, Swietokrzyskie, 폴란드, 25-364
        • NZOZ PrimaMED
  • 헝가리
      • Balatonfüred, 헝가리, 8230
        • Drug Research Center
      • Budapest, 헝가리, 1036
        • Synexus Hungary Ltd
      • Eger, 헝가리, 3300
        • Markhot Ferenc Hospital
      • Nagykanizsa, 헝가리, 8800
        • Kanizsai Dorottya Hospital
      • Nyíregyháza, 헝가리, 4400
        • Borbanya Praxis Kft., Outpatient Clinic
      • Nyíregyháza, 헝가리, 4400
        • Medifarma 98
      • Zalaegerszeg, 헝가리, 08900
        • Zala County 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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Written informed consent
  • Males and females, 18 to 75 years old, inclusive
  • Documented history of T2DM
  • Treatment naïve to antihyperglycemic therapy or having received no prior treatment with antihyperglycemic therapy for at least 90 days (TZDs for at least 24 weeks) prior to screening
  • Body mass index (BMI) 25 kg/m2 to 45 kg/m2 inclusive at screening
  • HbA1c 7% - 10%, inclusive at screening and at the end of the Qualifying Period (Day 14 +2 days)
  • Fasting serum glucose (FSG) of ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at screening and at the end of the Qualifying Period (Day 14 +2 days). A one-time central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG ≥ 125 mg/dL (6.9 mmol/L) and < 130 mg/dL (7.2 mmol/L) who are otherwise eligible as determined by the investigator.
  • Fasting serum C-peptide ≥ 0.8 ng/mL at screening
  • Able and willing to comply with all study procedures during the course of the study
  • Females of child-bearing potential must have a negative pregnancy test at screening and must agree to use highly effective contraception methods from screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug
  • At least 80% compliant with dosing during the Qualifying Period

Exclusion Criteria:

  • History of or current diagnosis of type 1 diabetes mellitus
  • History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
  • History of a severe episode of hypoglycemia (≥ 1 episode within 3 months prior to screening or ≥ 2 episodes within 6 months prior to screening), defined as hypoglycemia requiring 3rd party assistance to actively administer carbohydrate, glucagon, or other resuscitative actions due to severe impairment in consciousness or behavior
  • Clinically significant complications of diabetes that, in the judgment of the investigator, would make the subject unsuitable to participate in this study
  • History of any clinically significant cardiovascular or cerebrovascular event (eg, myocardial infarction [MI], acute coronary syndrome [ACS], recent coronary revascularization [including coronary artery bypass graft procedures or percutaneous coronary intervention], transient ischemic attack or ischemic stroke) ≤ 3 months prior to screening
  • Inadequately controlled or unstable hypertension as defined by systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at screening and randomization
  • Prolonged QTc interval > 500 msec by ECG at screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
  • History of bariatric surgery at any time in the past or any other surgery < 2 months before screening, or planning to undergo surgery during the study. Subjects with a planned minor surgery may be enrolled upon approval by the Medical Monitor.
  • Any other hospitalization in the 14 days prior to screening or planned hospitalization at any time during the study
  • Significant weight change (± 5%) < 2 months prior to screening or on a weight-loss program and is not in the maintenance phase at screening
  • Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) equation < 30 mL/min/1.73 m2 at screening or undergoing any type of dialysis at screening or planning to undergo any type of dialysis during the course of the study.
  • History of liver cirrhosis (Child-Pugh Class A, B or C)
  • Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 3x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3x ULN and/or serum total bilirubin > 2.0 mg/dL
  • History of cancer (except non-melanomic skin cancers or cervical in situ) within 5 years prior to screening
  • History of alcohol or other drug abuse < 12 months prior to screening
  • Any other clinically significant existing medical or psychiatric condition, including clinically significant laboratory abnormalities, or one requiring further evaluation that, in the opinion of the investigator, could interfere with conduct of the study or interpretation of the data
  • Prior treatment with open-label ranolazine or known hypersensitivity or intolerance to ranolazine or any of its excipients
  • Treatment with strong or moderate cytochrome (CYP)3A inhibitors or P-glycoprotein (P-gp) inhibitors within 14 days prior to randomization
  • Treatment with CYP3A inducers or P-gp inducers within 14 days prior to randomization
  • Treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, sirolimus) within 14 days prior to randomization
  • Treatment with simvastatin at a daily dose > 20 mg or lovastatin at a daily dose > 40 mg, within 14 days prior to randomization
  • Weight-loss medication or anti-obesity medication (prescription or nonprescription) < 3 months prior to screening
  • Treatment with niacin > 200 mg daily; if receiving ≤ 200 mg daily, should be on stable doses for ≥ 90 days prior to screening and for the duration of the study
  • Expected or current treatment with systemic corticosteroids (oral or injectable) for > 14 days from screening through the end of the Treatment Period. Topical or inhaled corticosteroid formulations are permitted at any time during the study
  • If receiving thyroid replacement therapy, should be on stable doses for at least 6 weeks prior to randomization
  • Hemoglobin < 12 g/dL for males; or < 11 g/dL for females, at screening
  • Participation in another clinical study involving an investigational drug or device < 30 days prior to screening; participation in another clinical study involving an antihyperglycemic therapy < 90 days prior to screening
  • Donation of blood < 2 months prior to screening; plans to donate blood while participating in the study
  • Females who are pregnant or breastfeeding
  • Other condition(s) that, in the opinion of the investigator, would compromise the safety of the subject, would prevent compliance with the study protocol (including the ability to comply with Mixed Meal Tolerance Test [MMTT]), or would compromise the quality of the clinical study

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: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Placebo

Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen.
행동: 다이어트
참가자는 의사가 처방한 식이 요법을 계속하도록 지시받습니다.
행동: 운동
참가자는 의사가 처방한 운동 요법을 계속하도록 지시받습니다.
의약품: Placebo
Placebo to match ranolazine administered orally twice daily.
실험적: Ranolazine

Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen.
행동: 다이어트
참가자는 의사가 처방한 식이 요법을 계속하도록 지시받습니다.
행동: 운동
참가자는 의사가 처방한 운동 요법을 계속하도록 지시받습니다.
의약품: Placebo
Placebo to match ranolazine administered orally twice daily.
의약품: Ranolazine
Ranolazine tablets administered orally twice daily.
다른 이름들:
  • 라넥사®

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
24주에 당화혈색소(HbA1c)의 기준선에서 변화
기간: 기준선 24주차
기준선으로부터 24주차에 HbA1c의 평균(평균) 변화를 분석했습니다.
기준선 24주차

2차 결과 측정

결과 측정
측정값 설명
기간
24주차에 공복 혈청 포도당의 기준선에서 변경
기간: 기준선 24주차
24주차에 공복 혈청 포도당의 기준선으로부터의 평균(평균) 변화를 분석했습니다.
기준선 24주차
Percentage of Participants With HbA1c < 7% at Week 24
기간: Week 24
Week 24
Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24
기간: Baseline; Week 24

The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.

Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at time [T] = 120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations and analyzed based on the randomized treatment regardless of actual treatment received.
Baseline; Week 24
Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24
기간: Baseline; Week 24
The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.
Baseline; Week 24

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Gilead Sciences

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

2011년 11월 1일

기본 완료 (실제)

2013년 10월 1일

연구 완료 (실제)

2013년 10월 1일

연구 등록 날짜

최초 제출

2011년 11월 11일

QC 기준을 충족하는 최초 제출

2011년 11월 11일

처음 게시됨 (추정)

2011년 11월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 10월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 10월 15일

마지막으로 확인됨

2014년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GS-US-259-0131

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. .

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정황

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약물 개입

식이 보충제

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3
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