Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus

PHASE3CompletedINTERVENTIONAL
Enrollment

431

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Ranolazine

Ranolazine tablet(s) administered orally

DRUG

Placebo

Placebo to match ranolazine for the duration of the study

DRUG

Glimepiride

Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily.

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.

Trial Locations (140)

1036

Synexus Hungary Ltd, Budapest

1818

Soweto Clinical Trial Centre, Johannesburg

2198

Centre fro Diabetes and Endocrinology (Pty) Ltd, Johannesburg

3300

Markhot Ferenc Hospital, Eger

4001

Drs. Naiker and Naicker Inc., Overport

4037

Newkwa Medical Centre, Newlands West

4091

Centre for Diabetes and Endocrinology Suite 1, Durban

4170

Aliwal Shoal Medical & Clinical Trial Centre, Kwa Zulu Natal

4400

Borbanya Praxis Kft., Outpatient Clinic, Nyíregyháza

Medifarma 98, Nyíregyháza

7130

Helderberg Clinical Trials Centre, Somerset West

7530

Tiervlei Trial Centre, Western Cape

7647

Paarl Research Centre, Paarl, Cape Town

8230

Drug Research Center, Balatonfüred

8800

Kanizsai Dorottya Hospital, Nagykanizsa

10002

Zhytomyr Regional Clinical Hospital, Zhytomyr

10330

Chulalongkorn University, Patumwan

10400

Phramongkutklao Hospital, Bangkok

Rajavithi Hospital, Bangkok

11000

Clinical Center of Serbia, Belgrade

Zvezdara University Medical Center, Belgrade

16150

Hospital Universiti Sains Malaysia, Kubang Kerian

20745

MD Medical Research, Oxon Hill

21204

IRC Clinics, Inc, Towson

27408

PharmQuest, Greensboro

28209

PMG Research of Charlotte, Charlotte

29687

Southeastern Research Associates, Inc., Taylors

30127

Synergy Therapeutic Partners, Atlanta

33140

NewPhase Clinical Trials, Inc., Miami Beach

33143

Regenerate Clinical Trials, South Miami

33511

PAB Clinical Research, Brandon

33716

Comprehensive Clinical Development, Inc., St. Petersburg

33880

Clinical Research of Central Florida, Winter Haven

34000

Clinical Center of Kragujevac, Kragujevac

34652

Suncoast Clinical Research, New Port Richey

37067

HCCA Clinical Research Solution, Franklin

37923

New Phase Research & Development, Knoxville

40213

L-MARC Research Center, Louisville

43024

Municipal Institution Lutsk City Clinical Hospital, Lutsk

45431

Clinical Inquest Center, Ltd., Beavercreek

46360

LaPorte County Institute for Clinical Research, Michigan City

49015

Associated Internal Medicine Specialists, P.C., Battle Creek

49023

City Clinical Hospital#9, Dnipropetrovsk State Medical Academy, Dnipropetrovsk

49707

Endeavor Medical Research, PLC, Alpena

60607

Cedar-Crosse Research Center, Chicago

65039

Odessa State Medical University, Odesa

70535

Horizon Research Group of Opelousas, Eunice

71603

Paul W. Davis, MD, PA, Pine Bluff

73103

Infinity Research Group, LLC, Oklahoma City

75390

The University of Texas Southwestern Medical Center at Dallas, Dallas

77081

Excel Clinical Research, LLC, Houston

Texas Center for Drug Development, Inc., Houston

77338

Humble Cardiology Associates, Humble

78229

Cetero Research, San Antonio

78237

Cetero Research, San Antonio

79010

Lviv Regional Endocrinology Dispensary, Lviv

83003

"Educational Scientific Medical Centre University clinic of Donetsk National Medical University n.a. M.Gorkiy", Donetsk

83616

CTL Research, Eagle

84124

Highland Clinical Research, Salt Lake City

Jean Brown Research, Salt Lake City

85213

Clinical Research Advantage/Desert Clinical Research, LLC, Mesa

85710

Desert Sun Clinical Research, LLC, Tucson

85745

Eclipse Clinical Research, Tucson

87102

Albuquerque Clinical Trials, Albuquerque

90057

National Research Institute, Los Angeles

90110

Songklanagarind Hospital, Songkhla

90255

Del Rosario Medical Clinic, Inc., Huntington Park

91307

Infosphere Clinical Research, West Hills

92037

Scripps Whittier Diabetes Institute, La Jolla

92553

Spectrum Clinical Research Institute, Inc, Moreno Valley

92708

Southland Clinical Research Center, Inc., Fountain Valley

95825

Sacramento Heart and Vascular Medical Associates, Sacramento

100163

Diabmed Dr. Popescu Alexandrina SRL, Ploieşti

117556

"State Healthcare Institution of Moscow Cardiologival Dispensary #2 of Management Department of South Administrative District", Moscow

117593

Central Clinical Hospital of Russian Academy of Sciences, Moscow

127299

Medical Sanitary Unit of Minestry of Internal Affairs of Russia in Moscow, Moscow

140091

"Clinic of New Medical Technology Company Limited", Dzerzhinskiy

143420

3rd Central Military Clinical Hospital named after A.A.Vishnevskogo, Arkhangel'skoye

150002

City Hospital named after N.A.Semashko, Yaroslavl

150003

Clinical Hospital for Emergency Care named after N.V. Solovyov, Yaroslavl

150023

Medical Sanitary Unit of Novo-Yaroslavsky Oil Refinery, Yaroslavl

150062

Yaroslavl Regional Clinical Hospital, Yaroslavl

190000

Medinet, LLC, Saint Petersburg

191015

North-Western State Medical Unversity n.a. I.I.Mechnikov, Saint Petersburg

191119

Saint-Petersburg City Outpatient Clinic#37, Saint Petersburg

191124

Military Medical Academy named after S.M. Kirov, Saint Petersburg

192283

"Saint-Petersburg state budgetary healthcare institution City Polyclinic #109", Saint Petersburg

193312

Alexanders City Hospital, Saint Petersburg

194291

Clinical Hospital #122 n.a. Sokolov of FMBA, Saint Petersburg

194354

"ANO Medical Centre XXI century", Saint Petersburg

195257

St. Elizabeth City Hospital, Saint Petersburg

196601

City Hospital # 38 named after N A Semashko, Pushkin

197042

Krestovsky Island Medical Institute, LLC, Saint Petersburg

197341

Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov, Saint Petersburg

198168

"International Medical Center SOGAZ, LLC", Saint Petersburg

199106

Saint-Petersburg City Pokrovskaya Hospital, Saint Petersburg

214019

Smolensk State Medical Academy, Sanatorium-Preventorium, Smolensk

300456

Centru Medical Dr. Negrisanu, Timișoara

344022

Rostov State Medical University, Rostov-on-Don

390005

Ryazan State Medical University, Ryazan

394082

Voronezh Regional Clinical Hospital #1, Voronezh

410169

Spital Clinic Judetean de Urgenta Oradea Stationarul 1, Oradea

443067

"Center Diabetes, LLC", Samara

603018

City Clinical Hospital # 13 of Avtozavodsky District of Nizhniy Novgorod, Nizhny Novgorod

620102

The Urals State Medical Academy, Yekaterinburg

625023

Tyumen State Medical Academy, Tyumen

630087

Novosibirsk State Medical University, Novosibirsk

630117

Scientific Research Institute of Physiology of Siberian Department RAMS, Novosibirsk

650066

Kemerovo Regional Clinical Hospital, Kemerovo

660062

"Krasnoyarsk State Medical University n.a. Prof. V.F. Voyno-Yasenetsky", Krasnoyarsk

672090

"GOU VPO Chita State Medical Academy of Minzdravsocrazvitie RF", Chita

700547

Consultmed SRL, Iași

800371

CMI Morosanu V. Magdalena, Galati

800578

"Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati", Galati

900675

CMI Mateescu S. Ana-Maria, Constanța

93720-2992

Valley Research, Fresno

32605-4253

Florida Research Network, LLC, Gainesville

37660-3256

Holston Medical Group, Kingsport

736 01

Interni oddeleni, Havířov

50-349

NZOZ Centrum Badan Klinicznych, Wroclaw

80-546

Centrum Badan Klinicznych PI-House Sp. z o.o., Gdansk

30-015

LANDA - Specjalistyczne Gabinety Lekarskie, Krakow

90-153

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi, Oddział Kliniczny Diabetologii, Lodz

32-600

NZOZ Centrum Badan Klinicznych Oswiecim, Oswięcim

90-242

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo - Akcyjna, Lodz

90-302

NZOZ Centrum Medyczne Szpital Sw. Rodziny, Lodz

95-100

NZOZ Polimedica, Zgierz

020042

"Institutul de Diabet, Nutritie si Boli Metabolice Dr. N. C. Paulescu", Bucharest

020354

Tehnomed Trading Srl, Bucharest

020475

"Institutul National De Diabet, Nutritie Si Boli Metabolice Prof. Dr. N.C. Paulescu", Bucharest

020725

O.D. Medica Srl, Bucharest

811 08

METABOLKLINIK s.r.o., Bratislava

831 01

Metabolic Center of Dr. Katarina Raslova Ltd., Bratislava

07501

ARETEUS s.r.o., Diabetologicka ambulancia, Trebišov

901 01

MediVet s.r.o., Malacky

02601

ENDIAMED s.r.o, Dolný Kubín

01829

Centre for Diabetes, Asthma and Allergy, Johannesburg

04050

"Administration of Medical Service and Rehabilitation of ARTEM State Holding Company", Kyiv

National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clinic # 2 of Shevchenkovsky District, Kyiv

04114

V. P. Komissarenko Institute of Endocrinology and Metabolism of AMS of Ukraine, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01494987 - Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus | Biotech Hunter | Biotech Hunter