A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01555164
First received: March 13, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in subjects with type 2 diabetes mellitus who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise.


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 When Added to Metformin 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 Hemoglobin A1c [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in incremental change of 2-hour postprandial serum glucose [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The incremental change of 2-hour postprandial serum glucose (PPG) is defined as the difference between the 2-hour PPG and the fasting serum glucose (FSG).

  • Change from baseline in FSG or change from baseline in 2-hour PPG [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment: 442
Study Start Date: June 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranolazine Drug: Ranolazine
Subjects will receive one tablet of ranolazine 500 mg twice daily followed by two tablets of ranolazine 500 mg twice daily, in addition to metformin, for the duration of the study.
Other Name: Ranexa
Placebo Comparator: Placebo Drug: Placebo
Subjects will receive one tablet of matching placebo twice daily followed by two tablets of matching placebo twice daily, in addition to metformin, for the duration of the study.

Detailed Description:

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in subjects with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise. The study has been designed to determine the effect of ranolazine on glycemic control and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.

  Eligibility

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

Inclusion Criteria:

  • Documented history of T2DM
  • 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 7% to 10%, inclusive, at Screening and at the end of Period 1
  • C-peptide ≥ 0.8 ng/mL at Screening
  • FSG ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of Period 1

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • 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
  • 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)
  • 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) > 3x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3x 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 the start of Period 2
  • 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 Period 2 Day 1
  • Treatment with CYP3A inducers or P-gp inducers within 14 days prior to Period 2 Day 1
  • Treatment with simvastatin or lovastatin at a dose > 20 mg or > 40 mg daily, respectively, within 14 days prior to Period 2 Day 1
  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: NCT01555164

  Hide Study Locations
Locations
United States, Alabama
Fundamental Research LLC
Gulf Shores, Alabama, United States, 36542
United States, Alaska
KLR Business Group DBA Arkansas Clinical Research
Little Rock, Alaska, United States, 72205
United States, Arizona
Radiant Research, Inc.
Chandler, Arizona, United States, 85224
Central Phoenix Medical Clinic
Phoenix, Arizona, United States, 85020
Clinical Research Advantage
Tempe, Arizona, United States, 85282
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710
United States, California
National Research Institute
Los Angeles, California, United States, 90057
Ritchken and First MD's
San Diego, California, United States, 92117
Clearview Medical Research, LLC
Santa Clarita, California, United States, 91350
Metabolic Institute of America
Tarzana, California, United States, 91356
University Clinical Investigators
Tustin, California, United States, 92780
Infosphere Clinical Research
West Hills, California, United States, 91307
United States, Colorado
Colorado Springs Health Partners
Colorado Springs, Colorado, United States, 80906
United States, Florida
Boca Raton Clinical Research Associates, Inc.
Boca Raton, Florida, United States, 33432
MD Clinical Institute
Hallandale Beach, Florida, United States, 33009
A G A Clinical Trials
Hialeah, Florida, United States, 33012
Baptist Diabetes Associates
Miami, Florida, United States, 33156
Florida Institute for Clinical Research LLC
Orlando, Florida, United States, 32822
Medical Research Group of Central Florida
Sanford, Florida, United States, 32771
United States, Georgia
Synergy Therapeutic Partners
Atlanta, Georgia, United States, 30312
Perimeter Institute for Clinical Research
Atlanta, Georgia, United States, 30338
Columbus Research Foundation
Columbus, Georgia, United States, 31904
United States, Idaho
Advanced Clinical Research
Boise, Idaho, United States, 83642
Choose To Lose
Eagle, Idaho, United States, 83616
United States, Illinois
Cedar-Crosse Research Center
Chicago, Illinois, United States, 60607
United States, Louisiana
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States, 71301
Covington Medical Care
Mandeville, Louisiana, United States, 70471
Clinical Trials Management, LLC
Metairie, Louisiana, United States, 70006
United States, Maryland
MD Medical Research
Oxon Hill, Maryland, United States, 20745
United States, Nebraska
Bellevue Family Practice
Bellevue, Nebraska, United States, 68005
United States, Nevada
Clinical Research Advantage
Henderson, Nevada, United States, 89052
United States, New Mexico
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States, 87102
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131-0001
United States, North Carolina
PhysiqueMed Clinical Trials
Greensboro, North Carolina, United States, 27405
Clinical Trials of America Inc
Hickory, North Carolina, United States, 28601
University Medical Associates
Huntersville, North Carolina, United States, 28078
Northstate Clinical Research
Lenoir, North Carolina, United States, 28645
Carolina Research Center
Shelby, North Carolina, United States, 28150
United States, North Dakota
Lillestol Research
Fargo, North Dakota, United States, 58103
United States, Ohio
Rapid Medical Research, Inc
Cleveland, Ohio, United States, 44122
Columbus Clinical Research Inc.
Columbus, Ohio, United States, 43213
Hometown Urgent Care and Research
Dayton, Ohio, United States, 45432
United States, Pennsylvania
Blair Medical Associates Inc.
Altoona, Pennsylvania, United States, 16602
United States, Rhode Island
Safe Harbor Clinical Research
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, United States, 29412
DeGarmo Institute of Medical Research
Greer, South Carolina, United States, 29651
United States, Tennessee
Holston Medical Group, P.C.
Bristol, Tennessee, United States, 37620
New Phase Research & Development
Knoxville, Tennessee, United States, 37923
United States, Texas
Corpus Christi, Texas, United States, 78414
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States, 75230
Juno Research, LLC
Houston, Texas, United States, 77074
Texas Center for Drug Development, Inc.
Houston, Texas, United States, 77081
West Houston Clinical Research
Houston, Texas, United States, 77055
Juno Research, LLC
Katy, Texas, United States, 77450
Northeast Clinical Research of San Antonio, LLC
Schertz, Texas, United States, 78154
Sugarland, Texas, United States, 77479
United States, Utah
Progressive Clinical Research, LLC
Bountiful, Utah, United States, 84010
Highland Clinical Research
Salt Lake City, Utah, United States, 84124
United States, Virginia
Burke Internal Medicine, Inc.
Burke, Virginia, United States, 22015
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
Canada, British Columbia
The Medical Arts Health Research Group
Kelowna, British Columbia, Canada, V1Y 3G8
Diabetes Research Clinic
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Ontario
Joanne F. Liutkus Medicine Professional Corporation
Cambridge, Ontario, Canada, N1R7L6
Source Unique Research
Hawkesbury, Ontario, Canada, K6A 1A1
Czech Republic
Nemocnice s poliklinikou Havirov
Havirov, Moravskoslezsky kraj, Czech Republic, 736-01
Restrial s.r.o.
Praha 8, Praha, Czech Republic, 18100
Hungary
Synexus Hungary Ltd
Budapest, Hungary, 1036
Selye János Kórház és Rendel?intézet, Belgyógyászati Szakrendelés
Komárom, Hungary, 2900
Kanizsai Dorottya Hospital
Nagykanizsa, Hungary, 8800
Medifarma 98
Nyíregyháza, Hungary, 4400
Borbanya Praxis Kft., Outpatient Clinic
Nyíregyháza, Hungary, 4405
India
Diabetomics India
Hyderabad, Andhra Pradesh, India, 500034
DHL Research Centre, 2nd Floor
Ahmadabad, Gujarat, India, 380015
Dia Care- A Complete Diabetes Care Center
Ahmadabad, Gujarat, India, 380015
Banker's Heart Institute
Vadodara, Gujarat, India, 390015
Baroda Medical College and SSG Hospital
Vadodara, Gujarat, India, 390001
Endocrinology & Diabetes Research Centre
Bangalore, Karnataka, India, 560003
Jnana Sanjeevani Medical Center
Bangalore, Karnataka, India, 560078
Manipal Hospital
Bangalore, Karnataka, India, 560017
Endocrinology Diabetes Centre
Bangalore, Karnataka, India, 560038
Bangalore Diabetes Hospital
Bangalore, Karnataka, India, 560043
The Bangalore Diabetes Hospital
Bangalore, Karnataka, India, 560052
Vinaya Hospital and Research Centre
Mangalore, Karnataka, India, 575003
Seth G. S. Medical College and KEM Hospital
Mumbai, Maharashtra, India, 400012
Institue of Clinical Endocrinology (I.C.E) and Diabetes Care Unit (D.C.U),
Nagpur, Maharashtra, India, 440010
Getwell Hospital and Research Institute
Nagpur, Maharashtra, India, 440012
KEM Hospital Research Center
Pune, Maharashtra, India, 411011
Diabetes Care and Research Centre
Pune, Maharashtra, India, 411011
Fortis City Centre
Chandigarh, Punjab, India, 160017
Diabetes and Heart Centre
Ludhiana, Punjab, India, 141008
Swamy Diabetes Centre
Chennai, Tamilnadu, India, 600028
Madras Diabetes Research Foundation
Chennai, Tamilnadu, India, 600086
Kovai Diabetes Speciality Centre & Hospital
Coimbatore, Tamilnadu, India, 641009
Israel
Soroka University Medical Center
Beer Sheva, Israel, 84101
Edith Wolfson Medical Center
Holon, Israel, 58100
Ziv Medical Center Safed-Israel
Safed, Israel, 13100
Mexico
Instituto Jalisciense de Investigación en Diabetes y Obesidad
Guadalajara, Jalisco, Mexico, 44600
Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo - Akcyjna
Lodz, Lodzkie, Poland, 90242
LANDA - Specjalistyczne Gabinety Lekarskie
Krakow, Malopolskie, Poland, 30-015
Niepubliczy Zaklad Opieki Zdrowotnej (NZOZ) Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, Poland, 15-435
NZOZ "Esculap" S.C.
Gniewkowo, Poland, 88-140
Russian Federation
GOU VPO "Chita State Medical Academy" of Minzdravsocrazvitie RF
Chita, Russian Federation, 672090
Clinic of New Medical Technology Company Limited
Dzerzhinskiy, Russian Federation, 140091
Kemerovo Regional Clinical Hospital
Kemerovo, Russian Federation, 650066
State Institution of Public Health of Moscow City Endocrinology Dispensary
Moscow, Russian Federation, 119034
Novosibirsk State Medical University
Novosibirsk, Russian Federation, 630087
Reafan, LLC
Novosibirsk, Russian Federation, 630099
Rostov State Medical University
Rostov-on-Don, Russian Federation, 344022
Ryazan State Medical University
Ryazan, Russian Federation, 29005
Center "Diabetes", LLC
Samara, Russian Federation, 443067
Smolensk State Medical Academy, Sanatorium-Preventorium
Smolensk, Russian Federation, 214019
ANO Medical Centre XXI Century
St. Petersburg, Russian Federation, 194354
Medinet, LLC
St. Petersburg, Russian Federation, 190000
North-Western State Medical Unversity n.a. I.I.Mechnikov
St. Petersburg, Russian Federation, 191015
SPb GBUZ Diagnostic Center #85
St. Petersburg, Russian Federation, 198255
Clinical Hospital #122 n.a. Sokolov of FMBA
St. Petersburg, Russian Federation, 194291
City Hospital #38 named after N. A. Semashko
St. Petersburg, Russian Federation, 196601
Federal State Budget Military Educational Institution Medical Military Academy n. a. S. M. Kirov
St. Petersburg, Russian Federation, 198013
Krestovsky Island Medical Institute, LLC
St. Petersburg, Russian Federation, 197042
Military Medical Academy named after S.M. Kirov
St. Petersburg, Russian Federation, 191124
Alexanders City Hospital
St. Petersburg, Russian Federation, 193312
Saint-Petersburg City Outpatient Clinic#37
St. Petersburg, Russian Federation, 191119
City Diabetology Center #4, "City Polyclinic #77"
St. Petersburg, Russian Federation, 192012
Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov
St. Petersburg, Russian Federation, 197341
City Hospital named after N.A.Semashko
Yaroslavl, Russian Federation, 150002
Yaroslavl Regional Clinical Hospital
Yaroslavl, Russian Federation, 150062
South Africa
Centre for Diabetes and Endocrinology Suite 1
Congella, Durban, South Africa, 4091
Vawda Z Private Practice
Kwa Zulu Natal, Durban, South Africa, 4091
Newkwa Medical Centre
Newlands West, Durban, South Africa, 4037
Drs. Naiker and Naicker Inc.
Overport, Durban, South Africa, 4001
Synexus Clinical Research SA (Pty) Ltd
Meyerspark, Pretoria, South Africa, 0102
East Rand Research Trading as Worthwhile Clinical Trials
Benoni, South Africa, 1500
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, South Africa, 2193
Netcare Umhlanga Medical Centre
Kwa Zulu Natal, South Africa, 4320
Aliwal Shoal Medical & Clinical Trial Centre
Kwa Zulu Natal, South Africa, 4170
Helderberg Clinical Trials Centre
Somerset West, South Africa, 7129
Ukraine
Educational Scientific Medical Centre, Donetsk National Medical University
Donetsk, Ukraine, 83003
State Institution "Institute of Problems of Endocrine Pathology n.a. V.Y. Danylevsky of NAMS of Ukra
Kharkiv, Ukraine, 61002
National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clini
Kyiv, Ukraine, 04050
Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
Kyiv, Ukraine, 04050
Ukrainian Scientific-and-Practical Center of Endocrine Surgery, Transplantation of Endocrine Organs
Kyiv, Ukraine, 02175
V. P. Komissarenko Institute of Endocrinology and Metabolism of AMS of Ukraine
Kyiv, Ukraine, 04114
Department of Endocrinology of Railway Clinical Hospital #2 of station "Kyiv" of South East Railroad
Kyiv, Ukraine, 03049
Odessa City Policlinic #20
Odesa, Ukraine, 65114
Odessa State Medical University
Odesa, Ukraine, 65039
Vinnytsya Regional Clinical Endocrinology Dispensary
Vinnytsya, Ukraine, 21010
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01555164     History of Changes
Other Study ID Numbers: GS-US-259-0147, 2012-001259-37
Study First Received: March 13, 2012
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Agency for Medicines and Medical Devices
India: Drugs Controller General of India
Israel: Ministry of Health
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014