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Clinical Trial Details

Trial ID: L3908
Source ID: NCT04537923
Associated Drug: Tirzepatide
Title: A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin
Acronym: SURPASS-6
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04537923/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Tirzepatide|DRUG: Insulin Lispro (U100)
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 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 with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52 | Secondary: Change From Baseline in HbA1c, 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 with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Percentage of Participants With HbA1c Target Values <7.0%, HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time., Week 52|Change From Baseline in Body Weight, LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Change From Baseline in Fasting Serum Glucose, LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline metformin Use (Yes, No) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|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 Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia, Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time., Week 52|Percentage of Participants Who Achieved Weight Loss ≥5%, Percentage of Participants who Achieved Weight Loss ≥5% is reported here., Week 52|Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score, The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. PCS score is reported here. PCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by analysis of covariance (ANCOVA) model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares)., Baseline, Week 52|Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score, The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. MCS consisted of social functioning, vitality, mental health, and role-emotional scales. MCS score is reported here. MCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by ANCOVA model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares)., Baseline, Week 52
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1428
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-10-19
Completion Date: 2022-11-01
Results First Posted: 2023-11-02
Last Update Posted: 2023-11-02
Locations: Syed Research Consultants Llc, Sheffield, Alabama, 35660, United States|Valley Research, Fresno, California, 93720, United States|National Research Institute - Huntington Park, Huntington Park, California, 90255, United States|National Research Institute - Huntington Park, Los Angeles, California, 90057, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|National Research Institute - Huntington Park, Panorama City, California, 91402, United States|National Research Institute (NRI) - Santa Ana, Santa Ana, California, 92704, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|University of Colorado, Aurora, Colorado, 80045, United States|Excel Medical Clinical Trials, Boca Raton, Florida, 33434, United States|I R & Health Center, Inc., Hialeah, Florida, 33012, United States|Sun Coast Clinical Research, Inc, New Port Richey, Florida, 34652, United States|South Broward Research, Pembroke Pines, Florida, 33027, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|J H. Stroger Hosp of Cook Co, Chicago, Illinois, 60612, United States|Prairie Education and Research Cooperative, Springfield, Illinois, 62711, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Capital Diabetes and Endocrine Associates, Camp Springs, Maryland, 20746, United States|MedStar Health Research Institute, Hyattsville, Maryland, 20782, United States|Endocrine and Metabolic Consultants, Rockville, Maryland, 20852, United States|Glacier View Research Institute - Endocrinology, Kalispell, Montana, 59901, United States|Southern Nh Diabetes and Endocrinology, Nashua, New Hampshire, 03060, United States|Albany Medical College, Albany, New York, 12203, United States|PMG Research of Wilmington, Wilmington, North Carolina, 28401, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Tribe Clinical Research, LLC, Greenville, South Carolina, 29607, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Diabetes and Thyroid Center of Fort Worth, Fort Worth, Texas, 76132, United States|Juno Research, Houston, Texas, 77040, United States|Biopharma Informatic, LLC, Houston, Texas, 77084, United States|North Hills Medical Research, North Richland Hills, Texas, 76180, United States|Texas Diabetes & Endocrinology, P.A., Round Rock, Texas, 78681, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Martin Diagnostic Clinic, Tomball, Texas, 77375, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Centro Médico Viamonte, Caba, Buenos Aires, C1120AAC, Argentina|Investigaciones Medicas Imoba Srl, Caba, Buenos Aires, C1179AAB, Argentina|Instituto Centenario, Caba, Buenos Aires, C1204AAD, Argentina|Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta, Rosario, Buenos Aires, S2000BIF, Argentina|CIPADI, Godoy Cruz, Mendoza, M5501ARP, Argentina|Instituto Médico Catamarca, Rosario, Santa Fe, 2000, Argentina|Instituto Médico Especializado (IME), Buenos Aires, 1405, Argentina|Asociación de Beneficencia Hospital Sirio Libanés, Buenos Aires, C1419AHN, Argentina|CENUDIAB, Ciudad Autónoma de Buenos Aire, C1440AAD, Argentina|Centro Diabetologico Dr Waitman, Cordoba, 5000, Argentina|Centro Medico Privado San Vicente Diabetes, Cordoba, X5006CBI, Argentina|Sanatorio Parque, Salta, 4400, Argentina|AZ Damiaan Oostende, Oostende, 8400, Belgium|Centro de Pesq. em Diabetes e Doencas Endocrino Metabol., Fortaleza, Ceará, 60430-350, Brazil|CEDOES, Vitoria, ES, 29055-450, Brazil|Cline Research Center, Curitiba, Paraná, 80030, Brazil|QUANTA - Medicina Nuclear Alto da XV, Curitiba, Paraná, 80045-170, Brazil|Centro de Pesquisas em Diabetes, Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil|CPCLIN, São Paulo, SP, 01228-200, Brazil|Hospital PUC-CAMPINAS, Campinas, São Paulo, 13060-904, Brazil|CECIP - Centro de Estudos do Interior Paulista, Jaú, São Paulo, 17201-130, Brazil|CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda, São Bernardo do Campo, São Paulo, 09715-090, Brazil|ISPEM - Instituto São José dos Campos em Pesquisas Médicas, São José dos Campos, São Paulo, 12243-280, Brazil|Instituto Brasil de Pesquisa Clínica - IBPCLIN, Rio de Janeiro, 20241180, Brazil|IPEC - Instituto de Pesquisa Clínica, São Paulo, 01223-001, Brazil|CPQuali Pesquisa Clínica, São Paulo, 01228-000, Brazil|BR Trials - Ensaios Clínicos e Consultoria Ltda, São Paulo, 03325-050, Brazil|CEPIC - Centro Paulista de Investigação Clínica, São Paulo, 04266-010, Brazil|Diabetologicka ordinace pro dospele, Krnov, Moravskoslezský Kraj, 79401, Czechia|Diabetologicka a obezitologicka ambulance, Ceske Budejovice, 370 11, Czechia|Diahelp s.r.o., Interni a diabetologicka ambulance, Pardubice, 530 02, Czechia|ResTrial s.r.o., Praha 8, 181 00, Czechia|Schwerpunktpraxis für Diabetes, Hof, Bavaria, 95030, Germany|InnoDiab Forschung Gmbh, Essen, Nordrhein-Westfalen, 45136, Germany|Medizentrum Essen-Borbeck, Essen, Nordrhein-Westfalen, 45355, Germany|Zentrum für klinische Studien, Saint Ingbert, Saarland, 66386, Germany|RED-Institut GmbH, Oldenburg, Schleswig-Holstein, 23758, Germany|MVZ im Altstadt-Carree Fulda GmbH, Fulda, 36037, Germany|Diabetologische Schwerpunktpraxis Harburg, Hamburg, 21073, Germany|Diabeteszentrum Hamburg West, Hamburg, 22607, Germany|Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf, Wallerfing, 94574, Germany|Iatriko Palaiou Falirou, Medical Center, Palaio Faliro, Athens, 17562, Greece|Athens Euroclinic, Athens, Attiki, 11521, Greece|General Hospital of Thessaloniki Papageorgiou, N. Efkarpia, Thessaloniki, 56403, Greece|Thermi Clinic, Thermi, Thessaloniki, 57001, Greece|Belinus Bt, Debrecen, Hajdu-Bihar, 4025, Hungary|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet, Debrecen, Hajdu-Bihar, 4032, Hungary|Szent Margit Rendelőintézet Nonprofit Kft, Budapest, 1032, Hungary|TRANTOR'99 Bt. Anyagcsere Centrum, Budapest, 1213, Hungary|Policlinico Mater Domini, Germaneto, Catanzaro, 88100, Italy|Casa di Cura Multimedica-Policlinico Multispecialistico, Sesto San Giovanni, MI, 20099, Italy|Ospedale Luigi Sacco, Milano, 20157, Italy|Policlinico Univ. Agostino Gemelli, Roma, 00168, Italy|Instituto Jalisciense de Investigacion en Diabetes y Obesida, Guadalajara, Jalisco, 44600, Mexico|Unidad de patologia Clinica, Guadalajara, Jalisco, 44650, Mexico|Centro de Inv. Medica de Occidente, SC, Zapopan, Jalisco, 45116, Mexico|Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, N.l., 64460, Mexico|Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, Madero, Tamaulipas, 89440, Mexico|Centro de Endocrinologia y Nutricion del Turabo, Caguas, 00726, Puerto Rico|Paola Mansilla-Letelier, MD, Guaynabo, 00970, Puerto Rico|SC Endodigest SRL, Oradea, Bihor, 410151, Romania|S. C. Grandmed S.R.L., Oradea, Bihor, 410159, Romania|C.M.D.T.A. Neomed, Brasov, Brașov, 500283, Romania|SC Gama Diamed SRL, Mangalia, Constanta, 905500, Romania|CMI DNBM Dr. Pop Lavinia, Baia Mare, Maramures, 430222, Romania|SC Cosamext SRL, Targu Mures, Mures, 540098, Romania|SC Diabmed Dr Popescu Alexandrina SRL, Ploiesti, Prahova, 100179, Romania|SC Dianutrilife Medica SRL, Ploiesti, Prahova, 100561, Romania|Centrul Medical Dr. Negrisanu, Timisoara, Timis, 300456, Romania|Cabinetul Medical Nicodiab SRL, Bucharest, 010507, Romania|SC Nutrilife SRL, Bucuresti, 013671, Romania|Milena Sante SRL, Galati, 800001, Romania|Arkhangelsk Regional Clinical Hospital, Arkhangelsk, 163045, Russian Federation|Scientific and Clinical Center for Precision and Regenerative Medicine, Kazan, 420012, Russian Federation|Pirogov Russian National Research Medical University, Moscow, 109263, Russian Federation|First Moscow State Medical University, Moscow, 119435, Russian Federation|SPb GUZ "Diagnostic Center #85", Saint Petersburg, 198255, Russian Federation|City Consultative and Diagnostic Center #1, Saint-Petersburg, 194354, Russian Federation|Saint-Petersburg State Budgetary Institution of Healthcare Institution, Saint-Petersburg, 194354, Russian Federation|St.Petersburg Polyclinic #117, Saint-Petersburg, 194358, Russian Federation|Diacrin s.r.o., Bratislava, Bratislavský Kraj, 841 02, Slovakia|MediVet s.r.o., Malacky, Bratislavský Kraj, 901 01, Slovakia|Human care s.r.o., Kosice, Slovak Republic, 04012, Slovakia|Diabetes care s.r.o., Hnusta, 98101, Slovakia|Areteus s.r.o., Trebisov, 075 01, Slovakia|Hospital Quiron Infanta Luisa, Sevilla, Andalucía, 41010, Spain|Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, 39011, Spain|Complejo Hospitalario Universitario De Ferrol - Hospital Naval, Ferrol, La Coruna, 15405, Spain|Clínica Juaneda, Palma de Mallorca, 07014, Spain|Hospital Universitario Virgen Macarena, Sevilla, 41009, Spain|Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi, Adana, 01240, Turkey|Akdeniz University Medical Faculty, Antalya, 07059, Turkey|Aydin Adnan Menderes Universitesi, Aydin, 09010, Turkey|Gaziantep University Medical Faculty, Gaziantep, 27310, Turkey|Inonu Universitesi, Malatya, 44282, Turkey
URL: https://clinicaltrials.gov/show/NCT04537923

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress