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Clinical Trial Details

Trial ID: L5837
Source ID: NCT01494987
Associated Drug: Ranolazine
Title: Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01494987/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Ranolazine|DRUG: Placebo|DRUG: Glimepiride|BEHAVIORAL: Diet|BEHAVIORAL: Exercise
Outcome Measures: Primary: 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: 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. 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 T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations, analyzed based on the randomized treatment regardless of actual treatment received., Baseline; Week 24|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|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., Baseline; Week 24
Sponsor/Collaborators: Sponsor: Gilead Sciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 431
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-01
Completion Date: 2013-08
Results First Posted: 2014-09-01
Last Update Posted: 2014-11-18
Locations: Clinical Research Advantage/Desert Clinical Research, LLC, Mesa, Arizona, 85213, United States|Desert Sun Clinical Research, LLC, Tucson, Arizona, 85710, United States|Eclipse Clinical Research, Tucson, Arizona, 85745, United States|Paul W. Davis, MD, PA, Pine Bluff, Arkansas, 71603, United States|Southland Clinical Research Center, Inc., Fountain Valley, California, 92708, United States|Valley Research, Fresno, California, 93720-2992, United States|Del Rosario Medical Clinic, Inc., Huntington Park, California, 90255, United States|Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States|National Research Institute, Los Angeles, California, 90057, United States|Spectrum Clinical Research Institute, Inc, Moreno Valley, California, 92553, United States|Sacramento Heart and Vascular Medical Associates, Sacramento, California, 95825, United States|Infosphere Clinical Research, West Hills, California, 91307, United States|PAB Clinical Research, Brandon, Florida, 33511, United States|Florida Research Network, LLC, Gainesville, Florida, 32605-4253, United States|NewPhase Clinical Trials, Inc., Miami Beach, Florida, 33140, United States|Suncoast Clinical Research, New Port Richey, Florida, 34652, United States|Regenerate Clinical Trials, South Miami, Florida, 33143, United States|Comprehensive Clinical Development, Inc., St. Petersburg, Florida, 33716, United States|Clinical Research of Central Florida, Winter Haven, Florida, 33880, United States|Synergy Therapeutic Partners, Atlanta, Georgia, 30127, United States|CTL Research, Eagle, Idaho, 83616, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|LaPorte County Institute for Clinical Research, Michigan City, Indiana, 46360, United States|L-MARC Research Center, Louisville, Kentucky, 40213, United States|Horizon Research Group of Opelousas, Eunice, Louisiana, 70535, United States|MD Medical Research, Oxon Hill, Maryland, 20745, United States|IRC Clinics, Inc, Towson, Maryland, 21204, United States|Endeavor Medical Research, PLC, Alpena, Michigan, 49707, United States|Associated Internal Medicine Specialists, P.C., Battle Creek, Michigan, 49015, United States|Albuquerque Clinical Trials, Albuquerque, New Mexico, 87102, United States|PMG Research of Charlotte, Charlotte, North Carolina, 28209, United States|PharmQuest, Greensboro, North Carolina, 27408, United States|Clinical Inquest Center, Ltd., Beavercreek, Ohio, 45431, United States|Infinity Research Group, LLC, Oklahoma City, Oklahoma, 73103, United States|Southeastern Research Associates, Inc., Taylors, South Carolina, 29687, United States|HCCA Clinical Research Solution, Franklin, Tennessee, 37067, United States|Holston Medical Group, Kingsport, Tennessee, 37660-3256, United States|New Phase Research & Development, Knoxville, Tennessee, 37923, United States|The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, 75390, United States|Excel Clinical Research, LLC, Houston, Texas, 77081, United States|Texas Center for Drug Development, Inc., Houston, Texas, 77081, United States|Humble Cardiology Associates, Humble, Texas, 77338, United States|Cetero Research, San Antonio, Texas, 78229, United States|Cetero Research, San Antonio, Texas, 78237, United States|Highland Clinical Research, Salt Lake City, Utah, 84124, United States|Jean Brown Research, Salt Lake City, Utah, 84124, United States|Interni oddeleni, Havirov, Moravskoslezsky kraj, 736 01, Czech Republic|Drug Research Center, Balatonfüred, 8230, Hungary|Synexus Hungary Ltd, Budapest, 1036, Hungary|Markhot Ferenc Hospital, Eger, 3300, Hungary|Kanizsai Dorottya Hospital, Nagykanizsa, 8800, Hungary|Borbanya Praxis Kft., Outpatient Clinic, Nyíregyháza, 4400, Hungary|Medifarma 98, Nyíregyháza, 4400, Hungary|Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, 16150, Malaysia|NZOZ Centrum Badan Klinicznych, Wroclaw, Dolnoslaskie, 50-349, Poland|Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo - Akcyjna, Lodz, Lodzkie, 90-242, Poland|NZOZ Centrum Medyczne Szpital Sw. Rodziny, Lodz, Lodzkie, 90-302, Poland|NZOZ Polimedica, Zgierz, Lodzkie, 95-100, Poland|Centrum Badan Klinicznych PI-House Sp. z o.o., Gdansk, Pomorskie, 80-546, Poland|LANDA - Specjalistyczne Gabinety Lekarskie, Krakow, 30-015, Poland|SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi, Oddział Kliniczny Diabetologii, Lodz, 90-153, Poland|NZOZ Centrum Badan Klinicznych Oswiecim, Oswięcim, 32-600, Poland|Spital Clinic Judetean de Urgenta Oradea Stationarul 1, Oradea, Jud Bihor, 410169, Romania|Consultmed SRL, Iasi, Jud. Iasi, 700547, Romania|CMI Morosanu V. Magdalena, Galati, Judetul Galati, 800371, Romania|Centru Medical Dr. Negrisanu, Timisoara, Judical Timis, 300456, Romania|Tehnomed Trading Srl, Bucharest, 020354, Romania|O.D. Medica Srl, Bucharest, 020725, Romania|Institutul de Diabet, Nutritie si Boli Metabolice "Dr. N. C. Paulescu", Bucuresti, 020042, Romania|Institutul National De Diabet, Nutritie Si Boli Metabolice "Prof. Dr. N.C. Paulescu", Bucuresti, 020475, Romania|CMI Mateescu S. Ana-Maria, Constanta, 900675, Romania|Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati, Galati, 800578, Romania|Diabmed Dr. Popescu Alexandrina SRL, Ploiesti, 100163, Romania|3rd Central Military Clinical Hospital named after A.A.Vishnevskogo, Arkhangelskoe, 143420, Russian Federation|GOU VPO "Chita State Medical Academy" of Minzdravsocrazvitie RF, Chita, 672090, Russian Federation|"Clinic of New Medical Technology" Company Limited, Dzerzhinskiy, 140091, Russian Federation|The Urals State Medical Academy, Ekaterinburg, 620102, Russian Federation|Kemerovo Regional Clinical Hospital, Kemerovo, 650066, Russian Federation|"Krasnoyarsk State Medical University n.a. Prof. V.F. Voyno-Yasenetsky, Krasnoyarsk, 660062, Russian Federation|State Healthcare Institution of Moscow "Cardiologival Dispensary #2 of Management Department of South Administrative District", Moscow, 117556, Russian Federation|Central Clinical Hospital of Russian Academy of Sciences, Moscow, 117593, Russian Federation|Medical Sanitary Unit of Minestry of Internal Affairs of Russia in Moscow, Moscow, 127299, Russian Federation|City Clinical Hospital # 13 of Avtozavodsky District of Nizhniy Novgorod, Nizhniy Novgorod, 603018, Russian Federation|Novosibirsk State Medical University, Novosibirsk, 630087, Russian Federation|Scientific Research Institute of Physiology of Siberian Department RAMS, Novosibirsk, 630117, Russian Federation|City Hospital # 38 named after N A Semashko, Pushkin, 196601, Russian Federation|Rostov State Medical University, Rostov-on-Don, 344022, Russian Federation|Ryazan State Medical University, Ryazan, 390005, Russian Federation|Center "Diabetes", LLC, Samara, 443067, Russian Federation|Smolensk State Medical Academy, Sanatorium-Preventorium, Smolensk, 214019, Russian Federation|Medinet, LLC, St. Petersburg, 190000, Russian Federation|North-Western State Medical Unversity n.a. I.I.Mechnikov, St. Petersburg, 191015, Russian Federation|Saint-Petersburg City Outpatient Clinic#37, St. Petersburg, 191119, Russian Federation|Military Medical Academy named after S.M. Kirov, St. Petersburg, 191124, Russian Federation|Saint-Petersburg state budgetary healthcare institution "City Polyclinic #109", St. Petersburg, 192283, Russian Federation|Alexanders City Hospital, St. Petersburg, 193312, Russian Federation|Clinical Hospital #122 n.a. Sokolov of FMBA, St. Petersburg, 194291, Russian Federation|ANO "Medical Centre "XXI century", St. Petersburg, 194354, Russian Federation|St. Elizabeth City Hospital, St. Petersburg, 195257, Russian Federation|Krestovsky Island Medical Institute, LLC, St. Petersburg, 197042, Russian Federation|Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov, St. Petersburg, 197341, Russian Federation|International Medical Center "SOGAZ", LLC, St. Petersburg, 198168, Russian Federation|Saint-Petersburg City Pokrovskaya Hospital, St. Petersburg, 199106, Russian Federation|Tyumen State Medical Academy, Tyumen, 625023, Russian Federation|Voronezh Regional Clinical Hospital #1, Voronezh, 394082, Russian Federation|City Hospital named after N.A.Semashko, Yaroslavl, 150002, Russian Federation|Clinical Hospital for Emergency Care named after N.V. Solovyov, Yaroslavl, 150003, Russian Federation|Medical Sanitary Unit of Novo-Yaroslavsky Oil Refinery, Yaroslavl, 150023, Russian Federation|Yaroslavl Regional Clinical Hospital, Yaroslavl, 150062, Russian Federation|Clinical Center of Serbia, Belgrade, 11000, Serbia|Zvezdara University Medical Center, Belgrade, 11000, Serbia|Clinical Center of Kragujevac, Kragujevac, 34000, Serbia|METABOLKLINIK s.r.o., Bratislava, Bratislavsky kraj, 811 08, Slovakia|Metabolic Center of Dr. Katarina Raslova Ltd., Bratislava, Bratislavsky kraj, 831 01, Slovakia|ARETEUS s.r.o., Diabetologicka ambulancia, Trebisov, Kosicky kraj, 07501, Slovakia|ENDIAMED s.r.o, Dolny Kubin, Zilinsky kraj, 02601, Slovakia|MediVet s.r.o., Malacky, 901 01, Slovakia|Newkwa Medical Centre, Newlands West, Durban, 4037, South Africa|Drs. Naiker and Naicker Inc., Overport, Durban, 4001, South Africa|Centre for Diabetes and Endocrinology Suite 1, Durban, 4091, South Africa|Centre for Diabetes, Asthma and Allergy, Johannesburg, 01829, South Africa|Soweto Clinical Trial Centre, Johannesburg, 1818, South Africa|Centre fro Diabetes and Endocrinology (Pty) Ltd, Johannesburg, 2198, South Africa|Aliwal Shoal Medical & Clinical Trial Centre, Kwa Zulu Natal, 4170, South Africa|Paarl Research Centre, Paarl, Cape Town, 7647, South Africa|Helderberg Clinical Trials Centre, Somerset West, 7130, South Africa|Tiervlei Trial Centre, Western Cape, 7530, South Africa|Chulalongkorn University, Patumwan, Bangkok, 10330, Thailand|Phramongkutklao Hospital, Bangkok, 10400, Thailand|Rajavithi Hospital, Bangkok, 10400, Thailand|Songklanagarind Hospital, Songkla, 90110, Thailand|City Clinical Hospital#9, Dnipropetrovsk State Medical Academy, Dnipropetrovsk, 49023, Ukraine|Educational Scientific Medical Centre "University clinic" of Donetsk National Medical University n.a. M.Gorkiy, Donetsk, 83003, Ukraine|Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company, Kyiv, 04050, Ukraine|National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clinic # 2 of Shevchenkovsky District, Kyiv, 04050, Ukraine|V. P. Komissarenko Institute of Endocrinology and Metabolism of AMS of Ukraine, Kyiv, 04114, Ukraine|Municipal Institution Lutsk City Clinical Hospital, Lutsk, 43024, Ukraine|Lviv Regional Endocrinology Dispensary, Lviv, 79010, Ukraine|Odessa State Medical University, Odesa, 65039, Ukraine|Zhytomyr Regional Clinical Hospital, Zhytomyr, 10002, Ukraine
URL: https://clinicaltrials.gov/show/NCT01494987