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Clinical Trial Details

Trial ID: L6830
Source ID: NCT02058147
Associated Drug: Insulin Glargine/Lixisenatide Fixed Ratio Combination
Title: Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM
Acronym: LixiLan-O
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02058147/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Insulin glargine/lixisenatide Fixed Ratio Combination|DRUG: Insulin glargine (HOE901)|DRUG: Lixisenatide (AVE0010)|DRUG: Metformin
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 30, Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine. Change in HbA1c was calculated by subtracting baseline value from Week 30 value., Baseline, Week 30 | Secondary: Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30, Participants without Week 30 value for HbA1c were counted as non-responders., Week 30|Change in Plasma Glucose Excursion From Baseline to Week 30, Plasma glucose excursion = 2-hour postprandial plasma glucose (PPG) value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 30 value. Missing data was imputed using last observation carried forward (LOCF)., Baseline, Week 30|Change in Body Weight From Baseline to Week 30, Change in body weight was calculated by subtracting baseline value from Week 30 value., Baseline, Week 30|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30, Change in FPG was calculated by subtracting baseline value from Week 30 value., Baseline, Week 30|Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30, Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach., Baseline, Week 30|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30, Week 30|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period, Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L)., Baseline up to Week 30|Average Daily Insulin Glargine Dose at Week 30, The analysis included scheduled measurements obtained up to the date of last injection of the IMP, including those obtained after introduction of rescue therapy., Week 30|Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30, The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 30 value. Missing data was imputed using LOCF., Baseline, Week 30|Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period, Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). The analysis included all HbA1c measurements at Week 30, including those obtained after the IMP discontinuation or the introduction of rescue medication., Baseline up to Week 30|Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period, Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) was performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG \>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG \>200 mg/dL (11.1 mmol/L) or HbA1c \>8%., Baseline up to Week 30|Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year, Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L)., First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Percentage of Participants With Documented Symptomatic Hypoglycemia, Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L)., First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Percentage of Participants With Severe Symptomatic Hypoglycemia, Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not have been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk of injury to themselves or others., First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1170
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-02
Completion Date: 2015-06
Results First Posted: 2017-02-10
Last Update Posted: 2017-05-09
Locations: Investigational Site Number 840027, Phoenix, Arizona, 85028, United States|Investigational Site Number 840122, Phoenix, Arizona, 85032, United States|Investigational Site Number 840062, Tempe, Arizona, 85282, United States|Investigational Site Number 840023, Tempe, Arizona, United States|Investigational Site Number 840084, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840100, Anaheim, California, 92801, United States|Investigational Site Number 840065, Bell Gardens, California, 90201, United States|Investigational Site Number 840090, Chino, California, 91710, United States|Investigational Site Number 840002, Chula Vista, California, 91911, United States|Investigational Site Number 840013, Concord, California, 94520, United States|Investigational Site Number 840053, Fresno, California, 93720, United States|Investigational Site Number 840017, La Jolla, California, 92037, United States|Investigational Site Number 840070, Lancaster, California, 93534, United States|Investigational Site Number 840121, Long Beach, California, 90806, United States|Investigational Site Number 840126, Los Angeles, California, 90017, United States|Investigational Site Number 840044, Los Angeles, California, 90057, United States|Investigational Site Number 840101, Mission Hills, California, 91345, United States|Investigational Site Number 840086, Mission Viejo, California, 92691, United States|Investigational Site Number 840120, Mission Viejo, California, 92691, United States|Investigational Site Number 840005, Northridge, California, 91325, United States|Investigational Site Number 840034, Palm Springs, California, 92262, United States|Investigational Site Number 840074, Port Hueneme, California, 93041, United States|Investigational Site Number 840068, San Ramon, California, 94583, United States|Investigational Site Number 840067, Santa Ana, California, 92704, United States|Investigational Site Number 840029, Tarzana, California, 91356, United States|Investigational Site Number 840006, Temecula, California, 92591, United States|Investigational Site Number 840078, West Hills, California, 91345, United States|Investigational Site Number 840059, Aurora, Colorado, 80045, United States|Investigational Site Number 840038, Denver, Colorado, 80246, United States|Investigational Site Number 840104, Bradenton, Florida, 34208, United States|Investigational Site Number 840098, Miami, Florida, 33156-7563, United States|Investigational Site Number 840014, New Port Richey, Florida, 34652, United States|Investigational Site Number 840047, Ocoee, Florida, 34761, United States|Investigational Site Number 840056, Palm Harbor, Florida, 34684, United States|Investigational Site Number 840089, Atlanta, Georgia, 30322, United States|Investigational Site Number 840054, Lawrenceville, Georgia, 30046, United States|Investigational Site Number 840119, Woodstock, Georgia, 30189, United States|Investigational Site Number 840108, Idaho Falls, Idaho, 83404, United States|Investigational Site Number 840075, Arlington Heights, Illinois, 60005, United States|Investigational Site Number 840080, Chicago, Illinois, 60607, United States|Investigational Site Number 840026, Chicago, Illinois, 60612, United States|Investigational Site Number 840116, Chicago, Illinois, 60616, United States|Investigational Site Number 840050, Springfield, Illinois, 62704, United States|Investigational Site Number 840008, Avon, Indiana, 46123, United States|Investigational Site Number 840015, Avon, Indiana, 46123, United States|Investigational Site Number 840076, Avon, Indiana, 46123, United States|Investigational Site Number 840082, Evansville, Indiana, 47713, United States|Investigational Site Number 840031, Evansville, Indiana, 47714, United States|Investigational Site Number 840060, Evansville, Indiana, 47714, United States|Investigational Site Number 840048, Indianapolis, Indiana, 46202, United States|Investigational Site Number 840085, Indianapolis, Indiana, 46260, United States|Investigational Site Number 840012, Valparaiso, Indiana, United States|Investigational Site Number 840025, Waterloo, Iowa, 50702, United States|Investigational Site Number 840022, Lexington, Kentucky, 40504, United States|Investigational Site Number 840007, Louisville, Kentucky, 40213, United States|Investigational Site Number 840081, New Orleans, Louisiana, 70112, United States|Investigational Site Number 840097, Auburn, Maine, 04210, United States|Investigational Site Number 840063, Rockville, Maryland, 20852, United States|Investigational Site Number 840028, Bloomfield Hills, Michigan, United States|Investigational Site Number 840071, Chesterfield, Michigan, 48047, United States|Investigational Site Number 840001, Dearborn, Michigan, 48124, United States|Investigational Site Number 840091, Kalamazoo, Michigan, 49048, United States|Investigational Site Number 840009, Minneapolis, Minnesota, 55416, United States|Investigational Site Number 840024, Chesterfield, Missouri, 63017, United States|Investigational Site Number 840057, Butte, Montana, 59701, United States|Investigational Site Number 840042, Omaha, Nebraska, 68131, United States|Investigational Site Number 840109, Henderson, Nevada, 89052, United States|Investigational Site Number 840052, Las Vegas, Nevada, 89148, United States|Investigational Site Number 840069, Nashua, New Hampshire, 03063, United States|Investigational Site Number 840123, Morganville, New Jersey, 07751, United States|Investigational Site Number 840011, Albuquerque, New Mexico, 87131, United States|Investigational Site Number 840030, New Hyde Park, New York, 11042, United States|Investigational Site Number 840096, Syracuse, New York, 13214-2016, United States|Investigational Site Number 840039, Asheville, North Carolina, 28803, United States|Investigational Site Number 840021, Hickory, North Carolina, 28601, United States|Investigational Site Number 840046, Morehead City, North Carolina, 28557, United States|Investigational Site Number 840072, Morganton, North Carolina, 28655, United States|Investigational Site Number 840110, Salisbury, North Carolina, 28144, United States|Investigational Site Number 840095, Wilmington, North Carolina, 28401, United States|Investigational Site Number 840099, Winston-Salem, North Carolina, 27103, United States|Investigational Site Number 840004, Columbus, Ohio, 43213, United States|Investigational Site Number 840016, Maumee, Ohio, 43537, United States|Investigational Site Number 840103, Eugene, Oregon, 97404, United States|Investigational Site Number 840113, Portland, Oregon, 97201-3098, United States|Investigational Site Number 840036, Pittsburgh, Pennsylvania, 15473, United States|Investigational Site Number 840043, Tipton, Pennsylvania, 16684, United States|Investigational Site Number 840058, Anderson, South Carolina, 29621, United States|Investigational Site Number 840127, Charleston, South Carolina, 29407, United States|Investigational Site Number 840049, Greer, South Carolina, 29651, United States|Investigational Site Number 840114, Rapid City, South Dakota, 57701, United States|Investigational Site Number 840112, Bristol, Tennessee, 37620, United States|Investigational Site Number 840094, Knoxville, Tennessee, 37912, United States|Investigational Site Number 840051, Austin, Texas, 78758, United States|Investigational Site Number 840066, Corpus Christi, Texas, 78404, United States|Investigational Site Number 840111, Dallas, Texas, 75208, United States|Investigational Site Number 840020, Dallas, Texas, 75216, United States|Investigational Site Number 840064, Dallas, Texas, 75230, United States|Investigational Site Number 840003, Dallas, Texas, 75231, United States|Investigational Site Number 840088, Edinburg, Texas, 78539, United States|Investigational Site Number 840118, Fort Worth, Texas, 76132, United States|Investigational Site Number 840055, Houston, Texas, 77004, United States|Investigational Site Number 840087, Houston, Texas, 77030, United States|Investigational Site Number 840079, Hurst, Texas, 76054, United States|Investigational Site Number 840073, N Richland Hill, Texas, 76180, United States|Investigational Site Number 840019, San Antonio, Texas, 78229, United States|Investigational Site Number 840037, Draper, Utah, 84020, United States|Investigational Site Number 840093, Ogden, Utah, 84405, United States|Investigational Site Number 840061, Salt Lake City, Utah, 84102, United States|Investigational Site Number 840041, Salt Lake City, Utah, 84107, United States|Investigational Site Number 840040, Chesapeake, Virginia, 23321, United States|Investigational Site Number 840045, Norfolk, Virginia, 23510, United States|Investigational Site Number 840092, Norfolk, Virginia, 23510, United States|Investigational Site Number 840125, Richmond, Virginia, 23219, United States|Investigational Site Number 840115, Salem, Virginia, 24153, United States|Investigational Site Number 840010, Weber City, Virginia, 24290, United States|Investigational Site Number 840077, Federal Way, Washington, 98003, United States|Investigational Site Number 840102, Renton, Washington, 98055, United States|Investigational Site Number 840033, Milwaukee, Wisconsin, 53209-0996, United States|Investigational Site Number 036005, Box Hill, 3128, Australia|Investigational Site Number 036001, Camperdown, 2050, Australia|Investigational Site Number 036006, Kippa Ring, 4021, Australia|Investigational Site Number 036007, Logan Central, 4114, Australia|Investigational Site Number 056005, Brussels, 1070, Belgium|Investigational Site Number 056006, Brussel, 1090, Belgium|Investigational Site Number 056001, Leuven, 3000, Belgium|Investigational Site Number 124004, Kelowna, V1Y 1Z9, Canada|Investigational Site Number 124001, Toronto, M4G 3E8, Canada|Investigational Site Number 124002, Vancouver, V5Z 1M9, Canada|Investigational Site Number 152008, Osorno, 5311092, Chile|Investigational Site Number 152015, Puerto Varas, Chile|Investigational Site Number 152004, Santiago, 7500010, Chile|Investigational Site Number 152006, Santiago, 7500010, Chile|Investigational Site Number 152001, Santiago, 7591047, Chile|Investigational Site Number 152002, Santiago, 7980378, Chile|Investigational Site Number 152012, Santiago, 8053095, Chile|Investigational Site Number 152009, Santiago, 8330008, Chile|Investigational Site Number 152011, Talagante, Chile|Investigational Site Number 152014, Temuco, 4781156, Chile|Investigational Site Number 152003, Temuco, 4813299, Chile|Investigational Site Number 203004, Beroun, 26601, Czech Republic|Investigational Site Number 203008, Ceske Budejovice, 370 01, Czech Republic|Investigational Site Number 203014, Horovice, 26801, Czech Republic|Investigational Site Number 203012, Koprivnice, 742 21, Czech Republic|Investigational Site Number 203001, Pardubice, 53002, Czech Republic|Investigational Site Number 203005, Plzen, 32600, Czech Republic|Investigational Site Number 203003, Praha 10, 100 00, Czech Republic|Investigational Site Number 203009, Praha 2, 12808, Czech Republic|Investigational Site Number 203007, Praha 5, 15000, Czech Republic|Investigational Site Number 203013, Praha 9 - Klanovice, 19014, Czech Republic|Investigational Site Number 203006, Trutnov, 54101, Czech Republic|Investigational Site Number 203016, Ujezd U Brna, Czech Republic|Investigational Site Number 203015, Vsetin, 75501, Czech Republic|Investigational Site Number 208003, Aarhus C, 8000, Denmark|Investigational Site Number 208009, Horsens, 8700, Denmark|Investigational Site Number 208002, Kolding, 6000, Denmark|Investigational Site Number 208001, København Nv, 2400, Denmark|Investigational Site Number 208005, København S, 2300, Denmark|Investigational Site Number 208004, Viborg, 8800, Denmark|Investigational Site Number 233004, Paide, 72713, Estonia|Investigational Site Number 233002, Pärnu, 80018, Estonia|Investigational Site Number 233003, Tallinn, 13415, Estonia|Investigational Site Number 233001, Viljandimaa, 71024, Estonia|Investigational Site Number 250006, Corbeil Essonnes, 91109, France|Investigational Site Number 250002, La Rochelle Cedex, 17019, France|Investigational Site Number 250003, Pierre Benite, 69310, France|Investigational Site Number 250001, Venissieux, 69200, France|Investigational Site Number 276005, Berlin, 10115, Germany|Investigational Site Number 276003, Berlin, 13125, Germany|Investigational Site Number 276004, Dortmund, 44137, Germany|Investigational Site Number 276007, Dresden, 01069, Germany|Investigational Site Number 276001, Dresden, 01307, Germany|Investigational Site Number 276006, Hamburg, 20253, Germany|Investigational Site Number 276002, Neumünster, 24534, Germany|Investigational Site Number 348003, Balatonfüred, 8230, Hungary|Investigational Site Number 348007, Budapest, 1036, Hungary|Investigational Site Number 348006, Budapest, 1096, Hungary|Investigational Site Number 348002, Budapest, 1138, Hungary|Investigational Site Number 348011, Komárom, 2900, Hungary|Investigational Site Number 348008, Nagykanizsa, 8800, Hungary|Investigational Site Number 348004, Szeged, 6720, Hungary|Investigational Site Number 348010, Szekesfehervar, 8000, Hungary|Investigational Site Number 348012, Sátoraljaújhely, 3980, Hungary|Investigational Site Number 348001, Zalaegerszeg, 8900, Hungary|Investigational Site Number 380002, Bologna, 40138, Italy|Investigational Site Number 380006, Catanzaro, 88100, Italy|Investigational Site Number 380001, Milano, 20132, Italy|Investigational Site Number 380003, Napoli, 80131, Italy|Investigational Site Number 380005, Roma, 00133, Italy|Investigational Site Number 428002, Riga, LV-1011, Latvia|Investigational Site Number 428003, Riga, LV-1011, Latvia|Investigational Site Number 428004, Riga, LV-1050, Latvia|Investigational Site Number 428001, Sigulda, LV-2150, Latvia|Investigational Site Number 440003, Jonava, LT-55201, Lithuania|Investigational Site Number 440002, Kaunas, LT-49456, Lithuania|Investigational Site Number 440007, Kaunas, LT-50009, Lithuania|Investigational Site Number 440004, Kedainiai, LT-57164, Lithuania|Investigational Site Number 440006, Panevezys, LT-37355, Lithuania|Investigational Site Number 440005, Utena, LT-28151, Lithuania|Investigational Site Number 440001, Vilnius, LT-10323, Lithuania|Investigational Site Number 484005, Aguascalientes, 20230, Mexico|Investigational Site Number 484001, Cuernavaca, 62250, Mexico|Investigational Site Number 484002, Guadalajara, 44130, Mexico|Investigational Site Number 484004, Guadalajara, 44210, Mexico|Investigational Site Number 484009, Guadalajara, 44670, Mexico|Investigational Site Number 484007, Monterrey, 64020, Mexico|Investigational Site Number 484006, Monterrey, 64460, Mexico|Investigational Site Number 484010, Zapopan, 45116, Mexico|Investigational Site Number 616002, Bialystok, 15-435, Poland|Investigational Site Number 616005, Krakow, 31-261, Poland|Investigational Site Number 616006, Krakow, 31-548, Poland|Investigational Site Number 616007, Lodz, 94-074, Poland|Investigational Site Number 616004, Szczecin, 70-506, Poland|Investigational Site Number 616003, Warszawa, 01-518, Poland|Investigational Site Number 616001, Warszawa, 02-507, Poland|Investigational Site Number 616008, Zory, 44-240, Poland|Investigational Site Number 642008, Bucharest, 010825, Romania|Investigational Site Number 642007, Bucuresti, 020475, Romania|Investigational Site Number 642009, Cluj Napoca, 400006, Romania|Investigational Site Number 642006, Hunedoara, 331057, Romania|Investigational Site Number 642005, Iasi, 700547, Romania|Investigational Site Number 642002, Oradea, 410169, Romania|Investigational Site Number 642001, Targu Mures, 540142, Romania|Investigational Site Number 642004, Timisoara, 300133, Romania|Investigational Site Number 642003, Timisoara, 300456, Romania|Investigational Site Number 643006, Moscow, 119991, Russian Federation|Investigational Site Number 643008, Penza, 440026, Russian Federation|Investigational Site Number 643012, Petrozavodsk, 185019, Russian Federation|Investigational Site Number 643001, Saint-Petersburg, 190013, Russian Federation|Investigational Site Number 643014, Samara, 443067, Russian Federation|Investigational Site Number 643009, Saratov, 410026, Russian Federation|Investigational Site Number 643011, Saratov, 410053, Russian Federation|Investigational Site Number 643005, St-Petersburg, 190068, Russian Federation|Investigational Site Number 643007, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643002, St-Petersburg, 195257, Russian Federation|Investigational Site Number 643003, St. Petersburg, 194358, Russian Federation|Investigational Site Number 643016, Tomsk, 634050, Russian Federation|Investigational Site Number 643004, Voronezh, 394018, Russian Federation|Investigational Site Number 710002, Cap Town, 7530, South Africa|Investigational Site Number 710003, Cape Town, 7500, South Africa|Investigational Site Number 710005, Meyerspark, 0184, South Africa|Investigational Site Number 710007, Port Elizabeth, South Africa|Investigational Site Number 710004, Pretoria, 0122, South Africa|Investigational Site Number 710001, Somerset West, 7130, South Africa|Investigational Site Number 710006, Soweto, 4309, South Africa|Investigational Site Number 724012, Barcelona, 08003, Spain|Investigational Site Number 724009, Granada, 18012, Spain|Investigational Site Number 724004, Hostalets De Balenyà, 08550, Spain|Investigational Site Number 724011, La Coruña, 15006, Spain|Investigational Site Number 724007, Lugo, 27004, Spain|Investigational Site Number 724008, Madrid, 28034, Spain|Investigational Site Number 724005, Madrid, 28046, Spain|Investigational Site Number 724013, Palma De Mallorca, 07010, Spain|Investigational Site Number 724001, Quart De Poblet, 46930, Spain|Investigational Site Number 724006, Sant Joan Despí, 08970, Spain|Investigational Site Number 724003, Sevilla, 41010, Spain|Investigational Site Number 752001, Ljungby, 341 82, Sweden|Investigational Site Number 752003, Malmö, 211 52, Sweden|Investigational Site Number 752004, Rättvik, 79530, Sweden|Investigational Site Number 752005, Stockholm, 11526, Sweden|Investigational Site Number 752002, Vällingby, 16268, Sweden|Investigational Site Number 804002, Chernivtsi, 58022, Ukraine|Investigational Site Number 804009, Ivano-Frankovsk, 76008, Ukraine|Investigational Site Number 804010, Kyiv, 03049, Ukraine|Investigational Site Number 804007, Kyiv, 04050, Ukraine|Investigational Site Number 804006, Kyiv, Ukraine|Investigational Site Number 804012, Lviv, 79010, Ukraine|Investigational Site Number 804011, Vinnytsya, 21001, Ukraine|Investigational Site Number 804008, Vinnytsya, 21010, Ukraine|Investigational Site Number 826001, Coventry, CV2 2DX, United Kingdom|Investigational Site Number 826002, Dundee, DD1 9SI, United Kingdom|Investigational Site Number 826006, Guildford, GU2 7XX, United Kingdom|Investigational Site Number 826007, Leicester, LE5 4PW, United Kingdom|Investigational Site Number 826003, Norwich, NR1 3SR, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02058147