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Clinical Trial Details

Trial ID: L2754
Source ID: NCT03730662
Associated Drug: Tirzepatide
Title: A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk
Acronym: SURPASS-4
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03730662/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Tirzepatide|DRUG: Insulin Glargine
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg), HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline sodium-glucose co-transporter-2 inhibitor (SGLT-2i) use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52 | Secondary: Change From Baseline in HbA1c (5 mg), HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Change From Baseline in Body Weight, LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Percentage of Participants With HbA1c of <7.0%, HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing., Week 52|Change From Baseline in Fasting Serum Glucose, LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values, The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide, Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide, 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose of Week 7, 15, 23, 35|Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia, The hypoglycemia events were defined by participant reported events with blood glucose \<54mg/dL (\<3.0 mmol/L) or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Post-baseline comparisons between treatment and control group was evaluated using negative binomial model with variables : Number of episodes = Baseline HbA1c Group (\<=8.5%, \>8.5%) + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable, Baseline through Week 52
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 2002
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-11-20
Completion Date: 2021-04-22
Results First Posted: 2022-02-14
Last Update Posted: 2022-02-14
Locations: Advanced Research Center, Anaheim, California, 92805, United States|Valley Clinical Trials, Inc., Covina, California, 91723, United States|Marin Endocrine Associates, Greenbrae, California, 94904, United States|National Research Institute, Huntington Park, California, 90255, United States|Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States|First Valley Medical Group, Lancaster, California, 93534, United States|National Research Institute, Los Angeles, California, 90057, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Monterey Endocrine & Diabetes Institute, Inc., Monterey, California, 93940, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Desert Medical Group Inc, Palm Springs, California, 92262, United States|Havana Research Institute, Pasadena, California, 91105, United States|Western University of Health Sciences, Pomona, California, 91766, United States|LCGK Research, San Carlos, California, 94070, United States|Olive View Medical Center, Sylmar, California, 91342, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Touro University, Vallejo, California, 94592, United States|Coastal Metabolic Research Centre, Ventura, California, 93003, 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|Advanced Pharma Research, Cutler Bay, Florida, 33189, United States|South Florida Wellness & Clinical Research Institute, Margate, Florida, 33063, United States|Suncoast Research Group, LLC, Miami, Florida, 33135, United States|New Horizon Research Center, Miami, Florida, 33165, United States|Clinical Neuroscience Solutions Inc, Orlando, Florida, 32801, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Primary Care Specialists, LLC, Atlanta, Georgia, 30312, United States|Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Saltzer Medical Group. P.A., Nampa, Idaho, 83686, United States|Northwestern Feinberg School of Medicine, Chicago, Illinois, 60611, United States|NorthShore University HealthSystem, Skokie, Illinois, 60077, United States|University of Iowa Hospital & Clinic, Iowa City, Iowa, 52242, United States|Iowa Diabetes Research, West Des Moines, Iowa, 50265, United States|Cotton O'Neil Diabetes and Endocrinology Center, Topeka, Kansas, 66606, United States|Robley Rex VAMC, Louisville, Kentucky, 40206, United States|NECCR PrimaCare Research, LLC, Fall River, Massachusetts, 02721, United States|AA Medical Research Center, Flint, Michigan, 48504, United States|Troy Internal Medicine, PC, Troy, Michigan, 48098, United States|Clinical Research Professionals, Chesterfield, Missouri, 63005, United States|Glacier View Research Institute, Kalispell, Montana, 59901, United States|Montana Medical Research, Inc, Missoula, Montana, 59808, United States|Palm Research Center, Las Vegas, Nevada, 89128, United States|Palm Research Center, Las Vegas, Nevada, 89148, United States|Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, 03063, United States|PharmQuest, Greensboro, North Carolina, 27408, United States|Lillestol Research LLC, Fargo, North Dakota, 58104, United States|Rapid Medical Research Inc, Cleveland, Ohio, 44122, United States|Ohio State Univ College Of Medicine, Columbus, Ohio, 43210, United States|Aventiv Research, Columbus, Ohio, 43213, United States|Intend Research, Norman, Oklahoma, 73069, United States|The Corvallis Clinic P.C., Corvallis, Oregon, 97330, United States|Oregon Health and Science University, Portland, Oregon, 97239, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Capital Area Research, Camp Hill, Pennsylvania, 17011, United States|Detweiler Family Medicine, Lansdale, Pennsylvania, 19446, United States|Capital Area Research, Newport, Pennsylvania, 17074, United States|Parkside Family Medical, Philadelphia, Pennsylvania, 19144, United States|Preferred Primary Care Physicians- Bower Hill, Pittsburgh, Pennsylvania, 15243, United States|Mountain View Clinical Research, Inc., Greer, South Carolina, 29651, United States|The Research Center of the Upstate, Mauldin, South Carolina, 29662, United States|Holston Medical Group Clinical Research, Kingsport, Tennessee, 37660, United States|New Phase Research & Development, Knoxville, Tennessee, 37909, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|PCP for Life, Houston, Texas, 77070, United States|BFHC Research, San Antonio, Texas, 78249, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States|Martin Diagnostic Clinic, Tomball, Texas, 77375, United States|Alpine Research Organization, Farmington, Utah, 84025, United States|Burke Internal Medicine & Research, Burke, Virginia, 22015, United States|Private: Dr. Larry Stonesifer, Federal Way, Washington, 98003, United States|Capital Clinical Research Center, Olympia, Washington, 98502, United States|Walla Walla Clinic, Walla Walla, Washington, 99362, United States|Centro de Investigaciones Metabólicas (CINME), Caba, Buenos Aires, C1056ABJ, Argentina|Mautalen Salud e Investigación - Servicio de Endocrinología, Caba, Buenos Aires, C1128AAF, Argentina|Investigaciones Medicas IMOBA S.R.L., Caba, Buenos Aires, C1179AAB, Argentina|CEDIC-Centro de Investigaciones Clinicas, Caba, Buenos Aires, C1425DES, Argentina|CEMEDIC, Caba, Buenos Aires, C1440CFD, 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|CIPADI, Godoy Cruz, Mendoza, M5501ARP, Argentina|AXISMED SRL - Bioclinica Research Network, Buenos Aires, C1430CKE, 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|Centro Diabetologico Dr Waitman, Cordoba, 5000, Argentina|Centro Medico Privado San Vicente Diabetes, Cordoba, X5006CBI, Argentina|Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC, Cordoba, X5008HHW, Argentina|Paratus Clinical Blacktown Clinic, Blacktown, New South Wales, 2148, Australia|Campbelltown Medical & Dental Centre, Campbelltown, New South Wales, 2560, Australia|Paratus Clinical Kanwal Clinic, Kanwal, New South Wales, 2259, Australia|The AIM Centre, Merewether, New South Wales, 2291, Australia|Royal North Shore Hospital, St. Leonards, New South Wales, 2065, Australia|CORE Research Group Pty Ltd, Brisbane, Queensland, 4064, Australia|Morayfield Medical and Dental Centre, Morayfield, Queensland, 4506, Australia|AusTrials Pty Ltd, Sherwood, Queensland, 4075, Australia|Victoria Point Medical and Dental Centre, Victoria Point, Queensland, 4165, Australia|GP Plus Marion, Oaklands Park, South Australia, 5046, Australia|Eastern Clinical Research Unit, Box Hill, Victoria, 3128, Australia|Forest Hill Medical and Dental Centre, Forest Hill, Victoria, 3131, Australia|Barwon Health - The Geelong Hospital, Geelong, Victoria, 3220, Australia|Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|Fremantle Hospital, Fremantle, Western Australia, 6160, Australia|Instituto de Ensino e Pesquisa Clinica do Ceara, Fortaleza, Ceara, 60170-195, Brazil|Centro de Pesquisa Clinica do Brasil, Brasilia, Distrito Federal, 71625-009, Brazil|Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd, Vitoria, ES, 29055-450, Brazil|Centro de Diabetes Curitiba, Curitiba, Parana, 80810-040, Brazil|CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA, Rio de Janeiro, RJ, 22271-100, Brazil|CPQuali Pesquisa Clínica Ltda., São Paulo, SP, 01228-000, Brazil|Cpclin Centro de Pesquisas Clinicas, São Paulo, SP, 01228-200, Brazil|Centro de Pesq. em Diabetes e Doencas Endocrino Metabol., Fortaleza, 60430-350, Brazil|Dr. Consulta Clínica Médica LTDA, São Paulo, 01141-020, Brazil|LMC Manna Research, Calgary, Alberta, T2H 2G4, Canada|C-Health Diabetes and Endocrinology Clinic Calgary, Calgary, Alberta, T2V 4J2, Canada|Synergy Medical Research, Sherwood Park, Alberta, T8H 0N2, Canada|LMC Endocrinology Centres Ltd., Barrie, Ontario, L4N 7L3, Canada|LMC Endocrinology Centers Brampton, Brampton, Ontario, L6S 0C6, Canada|Aggarwal and Associates Ltd, Brampton, Ontario, L6T 0G1, Canada|LMC Endocrinology Centres Ltd., Concord, Ontario, L4K 4M2, Canada|Milestone Research Inc., London, Ontario, N5W6A2, Canada|LMC Endocrinology Centres Ltd., Nepean, Ontario, K2J 0V2, Canada|Bluewater Clinical Research Group Inc, Sarnia, Ontario, N7T 4X3, Canada|Canadian Centre for Research on Diabetes, Smiths Falls, Ontario, K7A 4W8, Canada|Manna Research, Inc., Stoney Creek, Ontario, L8J 3W2, Canada|Medicor Research Inc, Sudbury, Ontario, P3A 1W8, Canada|LMC Endocrinology Centres Ltd., Toronto, Ontario, M4G 3E8, Canada|Sameh Fikry Medicine Professional Corporation, Waterloo, Ontario, N2J 1C4, Canada|Q & T Research Outaouais, Gatineau, Quebec, J8Y 6S8, Canada|Centre De Recherche Clinique De Laval, Laval, Quebec, H7T 2P5, Canada|Manna Research (Quebec), Levis, Quebec, G6W 0M5, Canada|LMC Endocrinology Centres Ltd., Ville St-Laurent, Quebec, H4T 1Z9, Canada|Iatriko Palaiou Falirou, Medical Center, Palaio Faliro, Athens, 17562, Greece|Thermi Clinic, Thermi, Thessaloniki, 57001, Greece|University General Hospital of Larissa, Larissa, 41110, Greece|AHEPA Hospital, Thessaloniki, 54636, Greece|Euromedica - General Clinic of Thessaloniki, Thessaloniki, 54645, Greece|Ha'Emek Medical Center, Afula, 1834111, Israel|Soroka Medical Center, Beer Sheva, 8410101, Israel|Rambam Medical Center, Haifa, 3109601, Israel|Wolfson Medical Center, Holon, 5822012, Israel|Hadassah Medical Center, Jerusalem, 911201, Israel|Rabin Medical Center, Petach Tikva, 4941492, Israel|Sheba Medical Center, Ramat Gan, 5266202, Israel|Sakhnin Community Clinic, Clalit Health Services, Sakhnin, 3081000, Israel|Tel Aviv Sourasky Medical Center, Tel Aviv Jaffa, 6423906, Israel|Instituto Jalisciense de Investigacion en Diabetes y Obesida, Guadalajara, Jalisco, 04460, Mexico|Diseno y Planeacion en Investigacion Medica S.C., Guadalajara, Jalisco, 44130, Mexico|St. Lucas Clinical Research Center, Merida, Mexico State, 97217, Mexico|Unidad Medica para la Salud Integral (UMSI), Monterrey, Nuevo León, 66465, Mexico|Centro de Estudios de Investigacion Metabolicos y Cardiovasc, Tampico, Tamaulipas, 89000, Mexico|Investigacion en Salud y Metabolismo S.C, Chihuahua, 31217, Mexico|Centralny Szpital Kliniczny MSWiA Klinika Dermatologiczna, Warszawa, Mazowieckie, 02-507, Poland|Poradnia Diabetologiczna SN ZOZ Lege Artis, Bialystok, 15-404, Poland|NZOZ Diab-Endo-Met, Krakow, 31-261, Poland|Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A., Lodz, 90-242, Poland|NZOZ CenterMed Lublin, Lublin, 20-044, Poland|Gabinety Terpa, Lublin, 20-333, Poland|NZOZ Przychodnia Specjalistyczna MEDICA, Lublin, 20-538, 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|Woj. Zesp. Spec. Opieki Zdrowotnej, Wroclaw, 50-403, Poland|Emanuelli Research & Development Center, LLC, Arecibo, 00612, Puerto Rico|Manati Center for Clinical Research Inc, Manati, 00674, Puerto Rico|Ponce School of Medicine CAIMED Center, Ponce, 00716, Puerto Rico|Research and Cardiovascular Corp., Ponce, 00717, Puerto Rico|University Of Puerto Rico, Rio Pedras, 00936, Puerto Rico|GCM Medical Group PSC, San Juan, 00909, Puerto Rico|Consultorio Medico, San Juan, 00921, Puerto Rico|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|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|SC Nutrilife SRL, Bucuresti, 013671, Romania|Milena Sante SRL, Galati, 800001, Romania|Arkhangelsk the first city clinical hospital, Arkhangelsk, 163045, Russian Federation|FSBI Endocrinological Research Center of the MOH of the ROF, Moscow, 117036, Russian Federation|Novosibirsk Regional Clinical Hospital, Novosibirsk, 630087, Russian Federation|Ryazan Regional Clinincal Cardiology Dispensary, Ryazan, 390026, Russian Federation|City Hospital of Saint Martyr Elizabeth, Saint Petersburg, 193257, Russian Federation|Medical Military Academy, Saint Petersburg, 194044, Russian Federation|SPb GUZ "Diagnostic Center #85", Saint Petersburg, 198255, Russian Federation|City Consultative and Diagnostic Center, Saint-Petersburg, 194354, Russian Federation|Regional Clinical Hospital, Saratov, 410053, Russian Federation|Research & Practice Ltd, Yaroslavl, 150003, 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|DIA-MED CENTRUM s.r.o., Puchov, 02001, Slovakia|Tatratrial s.r.o., Roznava, 04801, Slovakia|MEDI-DIA s.r.o., Sabinov, 08301, Slovakia|Hospital Universitario Marques De Valdecilla, Santander, Cantabria, 39011, Spain|Hospital Universitario Quiron Madrid, Pozuelo de Alarcon, Madrid, 28223, Spain|Hospital de la Ribera, Alcira, Valencia, 46600, Spain|Instituto de Ciencias medicas, Alicante, 03004, Spain|Centro Periférico de Especialidades Bola Azul, Almeria, 04009, Spain|Hospital Quironsalud Barcelona- END, Barcelona, 08023, Spain|Hospital Clinico Universitario San Cecilio, Granada, 18016, Spain|Complexo Hospitalario Universitario A Coruña, CHUAC, La Coruña, 15006, Spain|Centro Especialidades San Jose Obrero (Barbarela), Malaga, 29006, Spain|Clinica Juaneda, Palma de Mallorca, 07014, Spain|Hospital Universitario Virgen Macarena, Sevilla, 41009, Spain|Clinica Nuevas Tecnologias en Diabetes y Endocrinologia, Seville, 41003, Spain|Cardinal Tien Hospital, Sindian City, Taipei County, 23148, Taiwan|Chang Gung Memorial Hospital - Kaohsiung, Kaohsiung City, 833, Taiwan|Chung Shan Medical University Hospital, Taichung City, 40201, Taiwan|Kuang Tien General Hospital, Taichung County, 433, Taiwan|China Medical University Hospital, Taichung, 40447, Taiwan|Chi-Mei Medical Center, Tainan City, 71004, Taiwan|National Cheng Kung University Hospital, Tainan, 70403, Taiwan|National Taiwan University Hospital, Taipei City, 10048, Taiwan|Taipei Veterans General Hospital, Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT03730662

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress