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Clinical Trial Details

Trial ID: L4678
Source ID: NCT03495102
Associated Drug: Dulaglutide
Title: A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Acronym: AWARD-11
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03495102/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Dulaglutide
Outcome Measures: Primary: Change in Hemoglobin A1c (HbA1c) From Baseline, HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 36 | Secondary: Change in Body Weight From Baseline, Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 36|Percentage of Participants Achieving HbA1c Target <7.0%, Percentage of participants achieving HbA1c target \<7.0%., Week 36|Change in Fasting Serum Glucose (FSG) From Baseline, Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 36|Rate of Documented Symptomatic Hypoglycemic Episodes, Hypoglycemia was defined as blood glucose \< 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable., Week 36|Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss), Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)., Week 4, Week 12, Week 36, Week 52|Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State, Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State., Week 4, Week 12, Week 36, Week 52
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1842
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-04-05
Completion Date: 2019-10-10
Results First Posted: 2020-06-12
Last Update Posted: 2020-06-12
Locations: Synexus- Chandler, Chandler, Arizona, 85224, United States|Synexus/Central Arizona Medical Associates, PC, Mesa, Arizona, 85206, United States|Central Phoenix Med Clinic LLC, Phoenix, Arizona, 85020, United States|Arkansas Clinical Research, Little Rock, Arkansas, 72205, United States|Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States|Valley Research, Fresno, California, 93720, United States|National Research Institute, Huntington Park, California, 90255, United States|National Research Institute, Los Angeles, California, 90057, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Pacific Research Partners, LLC, Oakland, California, 94607, United States|National Research Institute, Panorama City, California, 91402, United States|Sierra Clinical Research, Roseville, California, 95661, United States|Artemis Institute for Clinical Research, San Diego, California, 92103, United States|Care Access Research, Santa Clarita, California, 91321, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Diablo Clinical Research, Walnut Creek, California, 94598, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|ALL Medical Research, LLC, Cooper City, Florida, 33024, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|Suncoast Research Group, LLC, Miami, Florida, 33135, United States|New Horizon Research Center, Miami, Florida, 33175, United States|Oviedo Medical Research, Oviedo, Florida, 32765, United States|Urban Family Practice Associates, PC, Marietta, Georgia, 30067, United States|In-Quest Medical Research, LLC- Peachtree Corners, Peachtree Corners, Georgia, 30071, United States|Pacific Diabetes & Endocrine Center, Honolulu, Hawaii, 96813, United States|East West Medical Institute, Honolulu, Hawaii, 96814, United States|Elite Clinical Trials LLLP, Blackfoot, Idaho, 83221, United States|Saltzer Medical Group. P.A., Nampa, Idaho, 83686, United States|Prairie Education and Research Cooperative, Springfield, Illinois, 62711, United States|Synexus/Clinical Research Advantage, Evansville, Indiana, 47714, United States|Midwest Institute for Clinical Research, Indianapolis, Indiana, 46260, United States|Iderc, P.L.C., West Des Moines, Iowa, 50265, United States|InterMed, PA, Portland, Maine, 04101, United States|MedStar Health Research Institute, Hyattsville, Maryland, 20782, United States|NECCR PrimaCare Research, LLC, Fall River, Massachusetts, 02721, United States|Aa Mrc Llc, Flint, Michigan, 48504, United States|Troy Internal Medicine, PC, Troy, Michigan, 48098, United States|Clinical Research Professionals, Chesterfield, Missouri, 63005, United States|StudyMetrix Research, LLC, Saint Peters, Missouri, 63303, United States|Montana Health Research, Billings, Montana, 59102, United States|Glacier View Research Institute, Kalispell, Montana, 59901, United States|Premier Research, Trenton, New Jersey, 08611, United States|Manhattan Medical Research, New York, New York, 10016, United States|Great Lakes Medical Research, Westfield, New York, 14787, United States|Metrolina Internal Medicine, P.A., Charlotte, North Carolina, 28207, United States|Diabetes & Endocrinology Consultants PC, Morehead City, North Carolina, 28557, United States|Aventiv Research, Columbus, Ohio, 43213, United States|Intend Research, Norman, Oklahoma, 73069, United States|IPS Research Company, Oklahoma City, Oklahoma, 73103, United States|The Corvallis Clinic P.C., Corvallis, Oregon, 97330, United States|Summit Research Network Inc, Portland, Oregon, 97210, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Detweiler Family Medicine, Lansdale, Pennsylvania, 19446, United States|Preferred Primary Care Physicians, Pittsburgh, Pennsylvania, 15236, United States|Sudir Bansal M.D. Inc., Warwick, Rhode Island, 02886, United States|PMG Research of Charleston, LLC, Moncks Corner, South Carolina, 29461, United States|Chattanooga Research and Medicine (CHARM), Chattanooga, Tennessee, 37404, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|Southern Endocrinology and Associates PA, Mesquite, Texas, 75149, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States|Martin Diagnostic Clinic, Tomball, Texas, 77375, United States|ClinPoint Trials, LLC, Waxahachie, Texas, 75165, United States|Progressive Clinical Research, Bountiful, Utah, 84010, United States|Advanced Research Institute, Ogden, Utah, 84405, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Clinical Research Partners, LLC, Richmond, Virginia, 23235, United States|Capital Clincial Research Center, Olympia, Washington, 98502, United States|Walla Walla Clinic, Walla Walla, Washington, 99362, United States|Wenatchee Valley Hospital & Clinics, Wenatchee, Washington, 98801, United States|Prevea Clinic, Inc, Green Bay, Wisconsin, 54303, United States|Centro Medico CICEMO, Caba, Buenos Aires, 1405, Argentina|CEDIC-Centro de Investigaciones Clinicas, Caba, Buenos Aires, 1425, Argentina|Investigaciones Medicas IMOBA S.R.L., Caba, Buenos Aires, C1179AAB, Argentina|Centro de Investigaciones Metabólicas (CINME), Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ, Argentina|Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada, Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425AGC, Argentina|Centro de Investigacion y Prevencion Cardiovascular (CIPREC), Ciudad Autonoma de, Buenos Aires, C1119ACN, Argentina|Instituto de Investigaciones Clinicas Mar del Plata, Mar del Plata, Buenos Aires, B7600FZN, Argentina|CIPADI, Godoy Cruz, Mendoza, M5501ARP, Argentina|AXISMED SRL - Bioclinica Research Network, Buenos Aires, C1430CKE, Argentina|CENUDIAB, Ciudad Autonoma de Buenos Aire, 1408, Argentina|Centro Médico Viamonte, Ciudad Autonoma de Buenos Aire, C1120AAC, Argentina|Instituto Centenario, Ciudad Autonoma de Buenos Aire, C1204AAD, Argentina|Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff, Ciudad Autonoma de Buenos Aire, C1205AAO, Argentina|Mautalen Salud e Investigación - Servicio de Endocrinología, Ciudad Autonoma De Buenos Air, C1128AAF, Argentina|Instituto Medico Strusberg, Cordoba, X5000EDC, Argentina|Centro Medico Privado San Vicente Diabetes, Cordoba, X5006CBI, Argentina|Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC, Cordoba, X5008HHW, Argentina|Landesklinikum Korneuburg-Stockerau, Standort Stockerau, Stockerau, Niederösterreich, 2000, Austria|Universitätsklinikum Graz, Graz, Steiermark, 8036, Austria|Ordination Dr. Evelyn Fließer-Görzer, Saint Stefan Ob Stainz, Steiermark, 8511, Austria|VIVIT Institut am LKH Feldkirch, Feldkirch, Vorarlberg, 6800, Austria|KA Rudolfstiftung, Wien, 1030, Austria|Zentrum für klinische Studien Dr. Ursula Hanusch GmbH, Wien, 1060, Austria|Bailey Clinic, Red Deer, Alberta, T4N 6V7, Canada|Aggarwal and Associates Ltd, Brampton, Ontario, L6T 0G1, Canada|T. Nemtean Medicine Professional Corporation, Mississauga, Ontario, L4Y 2N8, Canada|Bluewater Clinical Research Group Inc, Sarnia, Ontario, N7T 4X3, Canada|Stayner Medical Clinic, Stayner, Ontario, L0M 1S0, Canada|Dr. Anil K. Gupta Medicine Professional Corporation, Toronto, Ontario, M9V 4B4, Canada|Iatriko Palaiou Falirou, Medical Center, Palaio Faliro, Athens, 17562, Greece|Laiko General Hospital of Athens, Ampelokipoi, Attica, 11527, Greece|Gen Hospital of Athens G Gennimatas, Athens, Attiki, 11527, Greece|G.Papanikolaou General Hospital, Exohi, Thessaloniki, 57010, Greece|Thermi Clinic, Thermi, Thessaloniki, 57001, Greece|Athens Euroclinic, Athens, 11521, Greece|University General Hospital of Larissa, Larissa, 41110, Greece|AHEPA Hospital, Thessaloniki, 54636, Greece|Ippokrateio General Hospital of Thessaloniki, Thessaloniki, 54639, Greece|Euromedica - General Clinic of Thessaloniki, Thessaloniki, 54645, Greece|Studium Egeszseghaz Kft., Kalocsa, Bacs-Kiskun, 6300, Hungary|Kenezy Gyula Korhaz es Rendelointezet, Debrecen, Hajdu-Bihar, 4031, Hungary|Grof Esterhazy Korhaz es Rendelointezeti Szakrendelo, Papa, Veszprem, 8500, Hungary|Szent Margit Rendelointezet, Budapest, 1032, Hungary|ClinDiab Kft., Budapest, 1089, Hungary|Strazsahegy Medicina Bt., Budapest, 1171, Hungary|TRANTOR 99 Bt., Budapest, 1213, Hungary|Kanizsai Dorottya Korhaz, Nagykanizsa, 8800, Hungary|Zala Megyei Szent Rafael Korhaz, Zalaegerszeg, 8900, Hungary|Maccabi Diabetes Clinic, Grand Canyon, North District, Haifa, Haifa, 3299001, Israel|Linn Medical Center, Haifa, 3515209, Israel|Hadassah Medical Center, Jerusalem, 911201, Israel|Meir Medical Center, Kfar Saba, 4428164, Israel|Clalit Health Services - Shuali Clinic, Raanana, 4345204, Israel|ZIV Medical Center, Safed, 13100, Israel|Sakhnin Community Clinic, Clalit Health Services, Sakhnin, 3081000, Israel|Tel Aviv Sourasky Medical Center, Tel Aviv Jaffa, 6423906, Israel|Diabetes Medical Center (DMC), Tel Aviv, 6148002, Israel|Azienda Ospedaliera Universitaria Careggi, Firenze, Florence, 50134, Italy|Istituto Clinico Humanitas, Rozzano, Milano, 20089, Italy|A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena, SI, 53100, Italy|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24127, Italy|Policlinico Mater Domini, Catanzaro, 88100, Italy|Fondazione Universitaria degli Studi G D'Annunzio, Chieti, 66100, Italy|Ospedale Santa Maria Goretti, Latina, 04100, Italy|Policlinico Giaccone, Palermo, 90127, Italy|Ospedale Civile Maggiore Borgo Trento, Verona, 37126, Italy|Hospital Univ. Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo León, 64460, Mexico|Investigacion en Salud y Metabolismo S.C, Chihuahua, 31217, Mexico|NZOZ ZDROWIE Osteo-Medic, Bialystok, 15-351, Poland|Poradnia Diabetologiczna SN ZOZ Lege Artis, Bialystok, 15-404, Poland|NS ZOZ Osrodek Diabetologiczny " Popula", Bialystok, 15-445, Poland|Centrum Badan Klinicznych, PI House, Gdansk, 80-546, Poland|NZOZ Salvia s.c., Katowice, 40-772, Poland|NZOZ Diab-Endo-Met, Krakow, 31-261, Poland|Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A., Lodz, 90-242, Poland|Gabinety Terpa, Lublin, 20-333, Poland|NZOZ Przychodnia Specjalistyczna MEDICA, Lublin, 20-538, Poland|Centrum Medyczne OMEDICA, Poznan, 60-111, Poland|Praktyka Lekarska, Poznan, 61-655, Poland|Nzoz Neuro - Kard, Poznan, 61-853, Poland|NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek, Ruda Slaska, 41-709, Poland|Centralny Szpital Kliniczny MSW, Warszawa, 02-507, Poland|Regionalna Poradnia Diabetologiczna, Wroclaw, 50-127, Poland|Research and Cardiovascular Corp., Ponce, 00717, Puerto Rico|Clinical Research Puerto Rico, Inc., San Juan, 00909, Puerto Rico|GCM Medical Group PSC, San Juan, 00917, Puerto Rico|Office: Dr. Luis Rivera Colon, San Juan, 00921, Puerto Rico|S. C. Grandmed S.R.L., Str., Oradea, Bihor, 410159, Romania|SC Gama Diamed SRL, Mangalia, Constanta, 905500, Romania|Spitalul Judetean de Urgenta Satu Mare, Satu-Mare, Jud Satu-Mare, 440055, Romania|CMI DNBM Dr. Pop Lavinia, Baia Mare, Maramures, 430222, Romania|Cosamext SRL, Targu Mures, Mures, 540098, Romania|SC Diabmed Dr Popescu Alexandrina SRL, Ploiesti, Prahova, 100163, Romania|SC Dianutrilife Medica SRL, Ploiesti, Prahova, 100561, Romania|Centrul Medical Dr. Negrisanu, Timisoara, Timis, 300456, Romania|Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL, Brasov, 500283, Romania|Cabinetul Medical Nicodiab SRL, Bucharest, 010507, Romania|Easydiet SRL, Bucuresti, 010627, Romania|SC Nutrilife SRL, Bucuresti, 013682, Romania|SC Medcon SRL, Buzau, 120203, Romania|Centrul Medical Unirea SRL, Cluj Napoca, 400349, Romania|Cabinet Medical Urodiamed S.R.L., Craiova, 200349, Romania|Milena Sante SRL, Galati, 800001, Romania|SC Olimpia Med SRL, Iasi, 700400, Romania|Arkhangelsk Regional Clinical Hospital, Arkhangelsk, 163045, Russian Federation|Arkhangelsk the first city clinical hospital, Arkhangelsk, 163045, Russian Federation|Rostov State Medical University, Rostov-on-Don, 344022, Russian Federation|City Hospital of Saint Martyr Elizabeth, Saint Petersburg, 193257, Russian Federation|SPb GUZ "Diagnostic Center #85", Saint Petersburg, 198255, Russian Federation|Regional Clinical Hospital, Saratov, 410053, Russian Federation|Human care s.r.o., Kosice, Slovak Republic, 04012, Slovakia|MediVet s.r.o., Malacky, Slovak Republic, 90101, Slovakia|Areteus s.r.o., Trebisov, Slovak Republic, 07501, Slovakia|Diacrin s.r.o., Bratislava, 84102, Slovakia|Noemis, s.r.o., Nove Mesto nad Vahom, 91501, Slovakia|FUNKYSTUFF s.r.o., Nove Zamky, 94001, Slovakia|MUDr. Jan Culak, s.r.o., Prievidza, 97101, Slovakia|DIA-MED CENTRUM s.r.o., Puchov, 02001, Slovakia|Tatratrial s.r.o., Roznava, 04801, Slovakia|Hospital Infanta Luisa, Sevilla, Andalucía, 41010, Spain|Corporació Sanitaria Parc Tauli, Sabadell, Barcelona, 08208, Spain|Hospital Universitario Marques De Valdecilla, Santander, Cantabria, 39011, Spain|Clinica Juaneda, Palma de Mallorca, Islas Baleares, 07014, Spain|Hospital Universitario Quiron Madrid, Pozuelo de Alarcon, Madrid, 28223, Spain|Instituto de Ciencias medicas, Alicante, 03004, Spain|Clinica San Pedro, Almeria, 04001, Spain|Centre Medico Teknon, Barcelona, 08022, Spain|Hospital Clinico Universitario San Cecilio, Granada, 18012, Spain|Virgen de Las Nieves, Granada, 18014, Spain|Centro Especialidades San Jose Obrero (Barbarela), Malaga, 29006, Spain|Hospital Universitario Virgen Macarena, Sevilla, 41009, Spain|Clinica Nuevas Tecnologias en Diabetes y Endocrinologia, Seville, 41003, Spain|Policlinica Galileo, Teruel, 44002, Spain|Chung Shan Medical University Hospital, Taichung City, 40201, Taiwan|Taichung Veterans General Hospital, Taichung, 40705, ROC, Taiwan|Chi-Mei Medical Center, Tainan City, 71004, Taiwan
URL: https://clinicaltrials.gov/show/NCT03495102

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress