A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone

PHASE3CompletedINTERVENTIONAL
Enrollment

442

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

October 31, 2013

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Ranolazine

Ranolazine tablet(s) administered orally

DRUG

Placebo to match ranolazine

Placebo to match ranolazine for the duration of the study

DRUG

Metformin

Metformin tablet(s) administered orally once daily

DRUG

Placebo to match metformin

Placebo to match metformin for the duration of the study

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 (146)

1036

Synexus Hungary Ltd, Budapest

1500

East Rand Research Trading as Worthwhile Clinical Trials, Benoni

2193

Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg

2900

Selye János Kórház és Rendel?intézet, Belgyógyászati Szakrendelés, Komárom

4001

Drs. Naiker and Naicker Inc., Overport

4037

Newkwa Medical Centre, Newlands West

4091

Vawda Z Private Practice, Kwa Zulu Natal

Centre for Diabetes and Endocrinology Suite 1, KwaKhangela

4170

Aliwal Shoal Medical & Clinical Trial Centre, Kwa Zulu Natal

4320

Netcare Umhlanga Medical Centre, Kwa Zulu Natal

4400

Medifarma 98, Nyíregyháza

4405

Borbanya Praxis Kft., Outpatient Clinic, Nyíregyháza

7129

Helderberg Clinical Trials Centre, Somerset West

8800

Kanizsai Dorottya Hospital, Nagykanizsa

13100

Ziv Medical Center Safed-Israel, Safed

16602

Blair Medical Associates Inc., Altoona

18100

Restrial s.r.o., Prague

20110

Manassas Clinical Research Center, Manassas

20745

MD Medical Research, Oxon Hill

21010

Vinnytsya Regional Clinical Endocrinology Dispensary, Vinnytsia

22015

Burke Internal Medicine, Inc., Burke

27405

PhysiqueMed Clinical Trials, Greensboro

28078

University Medical Associates, Huntersville

28150

Carolina Research Center, Shelby

28601

Clinical Trials of America Inc, Hickory

28645

Northstate Clinical Research, Lenoir

29005

Ryazan State Medical University, Ryazan

29412

Pharmacorp Clinical Trials, Inc., Charleston

29651

DeGarmo Institute of Medical Research, Greer

30312

Synergy Therapeutic Partners, Atlanta

30338

Perimeter Institute for Clinical Research, Atlanta

31904

Columbus Research Foundation, Columbus

32771

Medical Research Group of Central Florida, Sanford

32822

Florida Institute for Clinical Research LLC, Orlando

33009

MD Clinical Institute, Hallandale

33012

A G A Clinical Trials, Hialeah

33156

Baptist Diabetes Associates, Miami

33432

Boca Raton Clinical Research Associates, Inc., Boca Raton

36542

Fundamental Research LLC, Gulf Shores

37620

Holston Medical Group, P.C., Bristol

37923

New Phase Research & Development, Knoxville

43213

Columbus Clinical Research Inc., Columbus

44122

Rapid Medical Research, Inc, Cleveland

44600

Instituto Jalisciense de Investigación en Diabetes y Obesidad, Guadalajara

45432

Hometown Urgent Care and Research, Dayton

58100

Edith Wolfson Medical Center, Holon

58103

Lillestol Research, Fargo

60607

Cedar-Crosse Research Center, Chicago

61002

"State Institution Institute of Problems of Endocrine Pathology n.a. V.Y. Danylevsky of NAMS of Ukra", Kharkiv

65039

Odessa State Medical University, Odesa

65114

Odessa City Policlinic #20, Odesa

68005

Bellevue Family Practice, Bellevue

70006

Clinical Trials Management, LLC, Metairie

70471

Covington Medical Care, Mandeville

71301

Alexandria Cardiology Clinic, Alexandria

72205

KLR Business Group DBA Arkansas Clinical Research, Little Rock

75230

Dallas Diabetes and Endocrine Center, Dallas

77055

West Houston Clinical Research, Houston

77074

Juno Research, LLC, Houston

77081

Texas Center for Drug Development, Inc., Houston

77450

Juno Research, LLC, Katy

77479

Sugarland

78154

Northeast Clinical Research of San Antonio, LLC, Schertz

78414

Corpus Christi

80906

Colorado Springs Health Partners, Colorado Springs

83003

Educational Scientific Medical Centre, Donetsk National Medical University, Donetsk

83616

Choose To Lose, Eagle

83642

Advanced Clinical Research, Boise

84010

Progressive Clinical Research, LLC, Bountiful

84101

Soroka University Medical Center, Beersheba

84124

Highland Clinical Research, Salt Lake City

85020

Central Phoenix Medical Clinic, Phoenix

85224

Radiant Research, Inc., Chandler

85282

Clinical Research Advantage, Tempe

85710

Desert Sun Clinical Research, LLC, Tucson

87102

Albuquerque Clinical Trials, Inc., Albuquerque

89052

Clinical Research Advantage, Henderson

90057

National Research Institute, Los Angeles

90242

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

91307

Infosphere Clinical Research, West Hills

91350

Clearview Medical Research, LLC, Santa Clarita

91356

Metabolic Institute of America, Tarzana

92117

Ritchken and First MD's, San Diego

92780

University Clinical Investigators, Tustin

119034

State Institution of Public Health of Moscow City Endocrinology Dispensary, Moscow

140091

Clinic of New Medical Technology Company Limited, Dzerzhinskiy

141008

Diabetes and Heart Centre, Ludhiana

150002

City Hospital named after N.A.Semashko, Yaroslavl

150062

Yaroslavl Regional Clinical Hospital, Yaroslavl

160017

Fortis City Centre, Chandigarh

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

192012

"City Diabetology Center #4, City Polyclinic #77", 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

196601

City Hospital #38 named after N. A. Semashko, Saint Petersburg

197042

Krestovsky Island Medical Institute, LLC, Saint Petersburg

197341

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

198013

Federal State Budget Military Educational Institution Medical Military Academy n. a. S. M. Kirov, Saint Petersburg

198255

SPb GBUZ Diagnostic Center #85, Saint Petersburg

214019

Smolensk State Medical Academy, Sanatorium-Preventorium, Smolensk

344022

Rostov State Medical University, Rostov-on-Don

380015

DHL Research Centre, 2nd Floor, Ahmedabad

Dia Care- A Complete Diabetes Care Center, Ahmedabad

390001

Baroda Medical College and SSG Hospital, Vadodara

390015

Banker's Heart Institute, Vadodara

400012

Seth G. S. Medical College and KEM Hospital, Mumbai

411011

Diabetes Care and Research Centre, Pune

KEM Hospital Research Center, Pune

440010

Institue of Clinical Endocrinology (I.C.E) and Diabetes Care Unit (D.C.U),, Nagpur

440012

Getwell Hospital and Research Institute, Nagpur

443067

"Center Diabetes, LLC", Samara

500034

Diabetomics India, Hyderabad

560003

Endocrinology & Diabetes Research Centre, Bangalore

560017

Manipal Hospital, Bangalore

560038

Endocrinology Diabetes Centre, Bangalore

560043

Bangalore Diabetes Hospital, Bangalore

560052

The Bangalore Diabetes Hospital, Bangalore

560078

Jnana Sanjeevani Medical Center, Bangalore

575003

Vinaya Hospital and Research Centre, Mangalore

600028

Swamy Diabetes Centre, Chennai

600086

Madras Diabetes Research Foundation, Chennai

630087

Novosibirsk State Medical University, Novosibirsk

630099

Reafan, LLC, Novosibirsk

641009

Kovai Diabetes Speciality Centre & Hospital, Coimbatore

650066

Kemerovo Regional Clinical Hospital, Kemerovo

672090

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

87131-0001

University of New Mexico Health Sciences Center, Albuquerque

02914

Safe Harbor Clinical Research, East Providence

V1Y 3G8

The Medical Arts Health Research Group, Kelowna

V5Z 1L8

Diabetes Research Clinic, Vancouver

N1R7L6

Joanne F. Liutkus Medicine Professional Corporation, Cambridge

K6A 1A1

Source Unique Research, Hawkesbury

736-01

Nemocnice s poliklinikou Havirov, Havířov

30-015

LANDA - Specjalistyczne Gabinety Lekarskie, Krakow

15-435

Niepubliczy Zaklad Opieki Zdrowotnej (NZOZ) Specjalistyczny Osrodek Internistyczno - Diabetologiczny, Bialystok

88-140

"NZOZ Esculap S.C.", Gniewkowo

0102

Synexus Clinical Research SA (Pty) Ltd, Meyerspark

02175

Ukrainian Scientific-and-Practical Center of Endocrine Surgery, Transplantation of Endocrine Organs, Kyiv

03049

"Department of Endocrinology of Railway Clinical Hospital #2 of station Kyiv of South East Railroad", Kyiv

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 Clini, 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