Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01472185
First received: November 11, 2011
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 are treatment naive to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days prior to screening, and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Ranolazine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change from baseline in HbA1c at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting serum glucose (FSG) at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with HbA1c < 7% at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from baseline in 2-hour postprandial serum glucose at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Enrollment: 465
Study Start Date: November 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranolazine
Participants will receive ranolazine for up to 24 weeks.
Drug: Ranolazine
Subjects will receive one tablet of ranolazine 500 mg twice daily for 7 days, followed by two tablets of ranolazine 500 mg twice daily for the duration of the study.
Other Name: Ranexa®
Placebo Comparator: Placebo
Participants will receive placebo to match ranolazine for up to 24 weeks.
Drug: Placebo
Subjects will receive placebo to match ranolazine for the duration of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (or thiazolidinediones [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 Period One (Day 14 +2 days)
  • FSG of ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of Period One (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 Period One

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 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 CYP3A 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 non-prescription) < 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472185

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

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01472185     History of Changes
Other Study ID Numbers: GS-US-259-0131
Study First Received: November 11, 2011
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Hungary: Institutional Ethics Committee
Hungary: National Institute of Pharmacy
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Slovakia: State Institute for Drug Control
Slovakia: Ethics Committee
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
Ukraine: Ethics Committee
Ukraine: Ministry of Health

Keywords provided by Gilead Sciences:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014