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Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

15 octobre 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

465

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: 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.
Comportemental: Régime
Les participants sont invités à poursuivre le régime alimentaire prescrit par leur médecin.
Comportemental: Exercer
Les participants sont invités à poursuivre le programme d'exercices prescrit par leur médecin.
Médicament: Placebo
Placebo to match ranolazine administered orally twice daily.
Expérimental: 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.
Comportemental: Régime
Les participants sont invités à poursuivre le régime alimentaire prescrit par leur médecin.
Comportemental: Exercer
Les participants sont invités à poursuivre le programme d'exercices prescrit par leur médecin.
Médicament: Placebo
Placebo to match ranolazine administered orally twice daily.
Médicament: Ranolazine
Ranolazine tablets administered orally twice daily.
Autres noms:
  • Ranexa®

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changement par rapport au départ de l'hémoglobine glycosylée (HbA1c) à la semaine 24
Délai: Base de référence ; Semaine 24
La variation moyenne (moyenne) par rapport au départ de l'HbA1c à la semaine 24 a été analysée.
Base de référence ; Semaine 24

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changement par rapport à la ligne de base de la glycémie à jeun à la semaine 24
Délai: Base de référence ; Semaine 24
La variation moyenne (moyenne) par rapport au départ de la glycémie à jeun à la semaine 24 a été analysée.
Base de référence ; Semaine 24
Percentage of Participants With HbA1c < 7% at Week 24
Délai: Week 24
Week 24
Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24
Délai: 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
Délai: 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

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Gilead Sciences

Publications et liens utiles

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Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2011

Achèvement primaire (Réel)

1 octobre 2013

Achèvement de l'étude (Réel)

1 octobre 2013

Dates d'inscription aux études

Première soumission

11 novembre 2011

Première soumission répondant aux critères de contrôle qualité

11 novembre 2011

Première publication (Estimation)

16 novembre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

24 octobre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 octobre 2014

Dernière vérification

1 octobre 2014

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Mots clés

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Autres numéros d'identification d'étude

  • GS-US-259-0131

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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