Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Diet; Behavioral: Exercise; Drug: Placebo; Drug: Ranolazine

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Behavioral: Diet; Participants are instructed to continue the diet regimen prescribed by their physician.; Behavioral: Exercise; Participants are instructed to continue the exercise regimen prescribed by their physician.; Drug: 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.	Behavioral: Diet; Participants are instructed to continue the diet regimen prescribed by their physician.; Behavioral: Exercise; Participants are instructed to continue the exercise regimen prescribed by their physician.; Drug: Placebo; Placebo to match ranolazine administered orally twice daily.; Drug: Ranolazine; Ranolazine tablets administered orally twice daily.; Other Names: Ranexa®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	The average (mean) change from baseline in HbA1c at Week 24 was analyzed.	Baseline; Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fasting Serum Glucose at Week 24	The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.	Baseline; Week 24
Percentage of Participants With HbA1c < 7% at Week 24		Week 24
Change From Baseline in 2-hour Postprandial Serum Glucose at 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	The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.	Baseline; Week 24

Collaborators and Investigators

• Sponsor: Gilead Sciences

Publications and helpful links

General Publications

• Eckel RH, Henry RR, Yue P, Dhalla A, Wong P, Jochelson P, Belardinelli L, Skyler JS. Effect of Ranolazine Monotherapy on Glycemic Control in Subjects With Type 2 Diabetes. Diabetes Care. 2015 Jul;38(7):1189-96. doi: 10.2337/dc14-2629. Epub 2015 Jun 6.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: November 11, 2011
• First Submitted That Met QC Criteria: November 11, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): October 24, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Sodium Channel Blockers; Ranolazine
• Other Study ID Numbers: GS-US-259-0131