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Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

15 de octubre de 2014 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

465

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: 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.
Conductual: Dieta
Se indica a los participantes que continúen con el régimen dietético prescrito por su médico.
Conductual: Ejercicio
Se indica a los participantes que continúen con el régimen de ejercicio prescrito por su médico.
Droga: Placebo
Placebo to match ranolazine administered orally twice daily.
Experimental: 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.
Conductual: Dieta
Se indica a los participantes que continúen con el régimen dietético prescrito por su médico.
Conductual: Ejercicio
Se indica a los participantes que continúen con el régimen de ejercicio prescrito por su médico.
Droga: Placebo
Placebo to match ranolazine administered orally twice daily.
Droga: Ranolazine
Ranolazine tablets administered orally twice daily.
Otros nombres:
  • Ranexa®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio desde el inicio en la hemoglobina glicosilada (HbA1c) en la semana 24
Periodo de tiempo: Base; semana 24
Se analizó el cambio promedio (media) desde el inicio en HbA1c en la semana 24.
Base; semana 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio desde el inicio en la glucosa sérica en ayunas en la semana 24
Periodo de tiempo: Base; semana 24
Se analizó el cambio promedio (media) desde el inicio en la glucosa sérica en ayunas en la semana 24.
Base; semana 24
Percentage of Participants With HbA1c < 7% at Week 24
Periodo de tiempo: Week 24
Week 24
Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

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Patrocinador

Gilead Sciences

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 2011

Finalización primaria (Actual)

1 de octubre de 2013

Finalización del estudio (Actual)

1 de octubre de 2013

Fechas de registro del estudio

Enviado por primera vez

11 de noviembre de 2011

Primero enviado que cumplió con los criterios de control de calidad

11 de noviembre de 2011

Publicado por primera vez (Estimar)

16 de noviembre de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de octubre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

15 de octubre de 2014

Última verificación

1 de octubre de 2014

Más información

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Otros números de identificación del estudio

  • GS-US-259-0131

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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