A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone
NCT ID: NCT01555164
Last Updated: 2014-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
442 participants
INTERVENTIONAL
2012-06-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ranolazine+metformin
Qualifying Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening).
Treatment Period: Participants will receive ranolazine 500 mg + metformin 500 mg + placebo to match metformin twice daily on Days 1 through 7, followed by ranolazine 1000 mg + metformin 500 mg + placebo to match metformin twice daily from Day 8 through Week 24.
Participants are required to maintain their diet and exercise regimen.
Ranolazine
Ranolazine tablet(s) administered orally
Metformin
Metformin tablet(s) administered orally once daily
Placebo to match metformin
Placebo to match metformin for the duration of the study
Diet
Participants are instructed to continue the diet regimen prescribed by their physician.
Exercise
Participants are instructed to continue the exercise regimen prescribed by their physician.
Placebo+metformin
Qualifying Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening).
Treatment Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily through Week 24.
Participants are required to maintain their diet and exercise regimen.
Placebo to match ranolazine
Placebo to match ranolazine for the duration of the study
Metformin
Metformin tablet(s) administered orally once daily
Diet
Participants are instructed to continue the diet regimen prescribed by their physician.
Exercise
Participants are instructed to continue the exercise regimen prescribed by their physician.
Interventions
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Ranolazine
Ranolazine tablet(s) administered orally
Placebo to match ranolazine
Placebo to match ranolazine for the duration of the study
Metformin
Metformin tablet(s) administered orally once daily
Placebo to match metformin
Placebo to match metformin for the duration of the study
Diet
Participants are instructed to continue the diet regimen prescribed by their physician.
Exercise
Participants are instructed to continue the exercise regimen prescribed by their physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metformin therapy at a stable total daily dose ≥ 1500 mg and ≤ 2550 mg in addition to diet and exercise for ≥ 8 weeks prior to Screening
* Body mass index (BMI) 25 to 45 kg/m\^2, inclusive, at Screening
* HbA1c within specified ranges at Screening and at the end of the Qualifying Period based on current metformin dose
* C-peptide ≥ 0.8 ng/mL at Screening
* Fasting serum glucose (FSG) ≥ 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
Exclusion Criteria
* History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
* History of severe hypoglycemia
* Any clinically significant cardiovascular or cerebrovascular event ≤ 3 months prior to Screening
* History of congestive heart failure
* Corrected QT interval (QTc) \> 500 msec by ECG at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or individuals who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
* Serum creatinine concentration ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females at Screening
* Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \> 3 x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) \> 3 x ULN and/or serum total bilirubin \> 2.0 mg/dL
* Use of any non-insulin antihyperglycemic therapy (other than metformin) for more than 14 days (consecutive or not) during the 12 weeks (24 weeks for thiazolidinediones) prior to Screening and/or use of any antihyperglycemic therapy other than metformin, at any dose, at any time during the 4 weeks prior to randomization
* Treatment with chronic insulin within 24 weeks prior to Screening (except for one temporary period of daily insulin injections no longer than 7 days)
* Treatment with strong or moderate cytochrome P450 3A (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 simvastatin or lovastatin at a dose \> 20 mg or \> 40 mg daily, respectively, within 14 days prior to randomization
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Yue, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Fundamental Research LLC
Gulf Shores, Alabama, United States
KLR Business Group DBA Arkansas Clinical Research
Little Rock, Alaska, United States
Radiant Research, Inc.
Chandler, Arizona, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Clinical Research Advantage
Tempe, Arizona, United States
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States
National Research Institute
Los Angeles, California, United States
Ritchken and First MD's
San Diego, California, United States
Clearview Medical Research, LLC
Santa Clarita, California, United States
Metabolic Institute of America
Tarzana, California, United States
University Clinical Investigators
Tustin, California, United States
Infosphere Clinical Research
West Hills, California, United States
Colorado Springs Health Partners
Colorado Springs, Colorado, United States
Boca Raton Clinical Research Associates, Inc.
Boca Raton, Florida, United States
MD Clinical Institute
Hallandale, Florida, United States
A G A Clinical Trials
Hialeah, Florida, United States
Baptist Diabetes Associates
Miami, Florida, United States
Florida Institute for Clinical Research LLC
Orlando, Florida, United States
Medical Research Group of Central Florida
Sanford, Florida, United States
Synergy Therapeutic Partners
Atlanta, Georgia, United States
Perimeter Institute for Clinical Research
Atlanta, Georgia, United States
Columbus Research Foundation
Columbus, Georgia, United States
Advanced Clinical Research
Boise, Idaho, United States
Choose To Lose
Eagle, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States
Covington Medical Care
Mandeville, Louisiana, United States
Clinical Trials Management, LLC
Metairie, Louisiana, United States
MD Medical Research
Oxon Hill, Maryland, United States
Bellevue Family Practice
Bellevue, Nebraska, United States
Clinical Research Advantage
Henderson, Nevada, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
PhysiqueMed Clinical Trials
Greensboro, North Carolina, United States
Clinical Trials of America Inc
Hickory, North Carolina, United States
University Medical Associates
Huntersville, North Carolina, United States
Northstate Clinical Research
Lenoir, North Carolina, United States
Carolina Research Center
Shelby, North Carolina, United States
Lillestol Research
Fargo, North Dakota, United States
Rapid Medical Research, Inc
Cleveland, Ohio, United States
Columbus Clinical Research Inc.
Columbus, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Blair Medical Associates Inc.
Altoona, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, United States
Holston Medical Group, P.C.
Bristol, Tennessee, United States
New Phase Research & Development
Knoxville, Tennessee, United States
Corpus Christi, Texas, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States
West Houston Clinical Research
Houston, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Juno Research, LLC
Katy, Texas, United States
Northeast Clinical Research of San Antonio, LLC
Schertz, Texas, United States
Sugarland, Texas, United States
Progressive Clinical Research, LLC
Bountiful, Utah, United States
Highland Clinical Research
Salt Lake City, Utah, United States
Burke Internal Medicine, Inc.
Burke, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
The Medical Arts Health Research Group
Kelowna, British Columbia, Canada
Diabetes Research Clinic
Vancouver, British Columbia, Canada
Joanne F. Liutkus Medicine Professional Corporation
Cambridge, Ontario, Canada
Source Unique Research
Hawkesbury, Ontario, Canada
Nemocnice s poliklinikou Havirov
Havířov, Moravskoslezský kraj, Czechia
Restrial s.r.o.
Prague, Prague, Czechia
Synexus Hungary Ltd
Budapest, , Hungary
Selye János Kórház és Rendel?intézet, Belgyógyászati Szakrendelés
Komárom, , Hungary
Kanizsai Dorottya Hospital
Nagykanizsa, , Hungary
Medifarma 98
Nyíregyháza, , Hungary
Borbanya Praxis Kft., Outpatient Clinic
Nyíregyháza, , Hungary
Diabetomics India
Hyderabad, Andhra Pradesh, India
DHL Research Centre, 2nd Floor
Ahmedabad, Gujarat, India
Dia Care- A Complete Diabetes Care Center
Ahmedabad, Gujarat, India
Baroda Medical College and SSG Hospital
Vadodara, Gujarat, India
Banker's Heart Institute
Vadodara, Gujarat, India
Endocrinology & Diabetes Research Centre
Bangalore, Karnataka, India
Manipal Hospital
Bangalore, Karnataka, India
Endocrinology Diabetes Centre
Bangalore, Karnataka, India
Bangalore Diabetes Hospital
Bangalore, Karnataka, India
The Bangalore Diabetes Hospital
Bangalore, Karnataka, India
Jnana Sanjeevani Medical Center
Bangalore, Karnataka, India
Vinaya Hospital and Research Centre
Mangalore, Karnataka, India
Seth G. S. Medical College and KEM Hospital
Mumbai, Maharashtra, India
Institue of Clinical Endocrinology (I.C.E) and Diabetes Care Unit (D.C.U),
Nagpur, Maharashtra, India
Getwell Hospital and Research Institute
Nagpur, Maharashtra, India
Diabetes Care and Research Centre
Pune, Maharashtra, India
KEM Hospital Research Center
Pune, Maharashtra, India
Fortis City Centre
Chandigarh, Punjab, India
Diabetes and Heart Centre
Ludhiana, Punjab, India
Swamy Diabetes Centre
Chennai, Tamil Nadu, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, India
Kovai Diabetes Speciality Centre & Hospital
Coimbatore, Tamil Nadu, India
Soroka University Medical Center
Beersheba, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Ziv Medical Center Safed-Israel
Safed, , Israel
Instituto Jalisciense de Investigación en Diabetes y Obesidad
Guadalajara, Jalisco, Mexico
LANDA - Specjalistyczne Gabinety Lekarskie
Krakow, Lesser Poland Voivodeship, Poland
Niepubliczy Zaklad Opieki Zdrowotnej (NZOZ) Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, , Poland
NZOZ "Esculap" S.C.
Gniewkowo, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo - Akcyjna
Lodz, Łódź Voivodeship, Poland
GOU VPO "Chita State Medical Academy" of Minzdravsocrazvitie RF
Chita, , Russia
Clinic of New Medical Technology Company Limited
Dzerzhinskiy, , Russia
Kemerovo Regional Clinical Hospital
Kemerovo, , Russia
State Institution of Public Health of Moscow City Endocrinology Dispensary
Moscow, , Russia
Novosibirsk State Medical University
Novosibirsk, , Russia
Reafan, LLC
Novosibirsk, , Russia
Rostov State Medical University
Rostov-on-Don, , Russia
Ryazan State Medical University
Ryazan, , Russia
Medinet, LLC
Saint Petersburg, , Russia
North-Western State Medical Unversity n.a. I.I.Mechnikov
Saint Petersburg, , Russia
Saint-Petersburg City Outpatient Clinic#37
Saint Petersburg, , Russia
Military Medical Academy named after S.M. Kirov
Saint Petersburg, , Russia
City Diabetology Center #4, "City Polyclinic #77"
Saint Petersburg, , Russia
Alexanders City Hospital
Saint Petersburg, , Russia
Clinical Hospital #122 n.a. Sokolov of FMBA
Saint Petersburg, , Russia
ANO Medical Centre XXI Century
Saint Petersburg, , Russia
City Hospital #38 named after N. A. Semashko
Saint Petersburg, , Russia
Krestovsky Island Medical Institute, LLC
Saint Petersburg, , Russia
Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov
Saint Petersburg, , Russia
Federal State Budget Military Educational Institution Medical Military Academy n. a. S. M. Kirov
Saint Petersburg, , Russia
SPb GBUZ Diagnostic Center #85
Saint Petersburg, , Russia
Center "Diabetes", LLC
Samara, , Russia
Smolensk State Medical Academy, Sanatorium-Preventorium
Smolensk, , Russia
City Hospital named after N.A.Semashko
Yaroslavl, , Russia
Yaroslavl Regional Clinical Hospital
Yaroslavl, , Russia
Vawda Z Private Practice
Kwa Zulu Natal, Durban, South Africa
Centre for Diabetes and Endocrinology Suite 1
KwaKhangela, Durban, South Africa
Newkwa Medical Centre
Newlands West, Durban, South Africa
Drs. Naiker and Naicker Inc.
Overport, Durban, South Africa
Synexus Clinical Research SA (Pty) Ltd
Meyerspark, Pretoria, South Africa
East Rand Research Trading as Worthwhile Clinical Trials
Benoni, , South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, , South Africa
Aliwal Shoal Medical & Clinical Trial Centre
Kwa Zulu Natal, , South Africa
Netcare Umhlanga Medical Centre
Kwa Zulu Natal, , South Africa
Helderberg Clinical Trials Centre
Somerset West, , South Africa
Educational Scientific Medical Centre, Donetsk National Medical University
Donetsk, , Ukraine
State Institution "Institute of Problems of Endocrine Pathology n.a. V.Y. Danylevsky of NAMS of Ukra
Kharkiv, , Ukraine
Ukrainian Scientific-and-Practical Center of Endocrine Surgery, Transplantation of Endocrine Organs
Kyiv, , Ukraine
Department of Endocrinology of Railway Clinical Hospital #2 of station "Kyiv" of South East Railroad
Kyiv, , Ukraine
Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
Kyiv, , Ukraine
National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clini
Kyiv, , Ukraine
V. P. Komissarenko Institute of Endocrinology and Metabolism of AMS of Ukraine
Kyiv, , Ukraine
Odessa State Medical University
Odesa, , Ukraine
Odessa City Policlinic #20
Odesa, , Ukraine
Vinnytsya Regional Clinical Endocrinology Dispensary
Vinnytsia, , Ukraine
Countries
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Other Identifiers
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2012-001259-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-259-0147
Identifier Type: -
Identifier Source: org_study_id
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