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Clinical Trial Details

Trial ID: L5560
Source ID: NCT03882970
Associated Drug: Tirzepatide
Title: A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes
Acronym: SURPASS-3
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03882970/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Tirzepatide|DRUG: Insulin Degludec
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 with covariates Baseline + Pooled Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus SGLT-2i) + 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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + 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 with Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates., Baseline, Week 52|Change From Baseline in Fasting Serum Glucose, LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Percentage of Participants Achieving an HbA1c Target Value of <7%, Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline Value, Pooled Country, Baseline OAM Use (Met, Met plus SGLT-2i), Treatment, Visit and Visit\*Treatment., 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 + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 52|Percentage of Participants Who Achieved Weight Loss ≥5%, Percentage of Participants who Achieved Weight Loss ≥5%, Week 52|Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score, DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 52 or early termination.The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline DTSQs + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment (Type III sum of squares)., Week 52|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. The rate of postbaseline hypoglycemia was estimated by negative binomial model: Number of episodes = Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable., Baseline through Safety Follow-Up (Up to Week 56)
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1444
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-04-01
Completion Date: 2021-01-04
Results First Posted: 2022-01-19
Last Update Posted: 2022-01-19
Locations: Arkansas Clinical Research, Little Rock, Arkansas, 72205, 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|National Research Institute, Panorama City, California, 91402, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Indago Research & Health Center, Inc., Hialeah, Florida, 33012, United States|East Coast Clinical Research, Jacksonville, Florida, 32204, United States|East Coast Institute For Research, Jacksonville, Florida, 32216, United States|Bayside Clinical Research, LLC, New Port Richey, Florida, 34655, United States|East Coast Institute For Research, Macon, Georgia, 31210, United States|Sky Clinical Research Network, Union City, Georgia, 30291, United States|Elite Clinical Trials LLLP, Blackfoot, Idaho, 83221, United States|Humphreys Diabetes Center, Boise, Idaho, 83702, United States|Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States|Springfield Diabetes & Endocrine Center, Springfield, Illinois, 62711, United States|Crescent City Clinical Research, Metairie, Louisiana, 70006, United States|Endocrine and Metabolic Consultants, Rockville, Maryland, 20852, United States|Troy Internal Medicine, PC, Troy, Michigan, 48098, United States|International Diabetes Center, Minneapolis, Minnesota, 55416, United States|Clinical Research Professionals, Chesterfield, Missouri, 63005, United States|Palm Research Center, Las Vegas, Nevada, 89128, United States|Palm Research Center, Las Vegas, Nevada, 89148, United States|Aventiv Research, Columbus, Ohio, 43213, United States|The Corvallis Clinic P.C., Corvallis, Oregon, 97330, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Detweiler Family Medicine, Lansdale, Pennsylvania, 19446, United States|Office of Dr. Osvaldo Brusco, Corpus Christi, Texas, 78414, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States|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|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|CENUDIAB, Ciudad Autonoma de Buenos Aire, C1440AAD, Argentina|Landesklinikum Korneuburg-Stockerau, Standort Stockerau, Stockerau, Niederösterreich, 2000, Austria|Universitätsklinikum Graz, Graz, Steiermark, 8036, Austria|Universitätsklinikum Salzburg, Salzburg, 5020, Austria|KA Rudolfstiftung, Wien, 1030, Austria|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|General Hospital of Thessaloniki Papageorgiou, N. Efkarpia, Thessaloniki, 56403, 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|Kenezy Gyula Korhaz es Rendelointezet, Debrecen, Hajdu-Bihar, 4031, Hungary|Szent Margit Rendelointezet, Budapest, 1032, Hungary|ClinDiab Kft., Budapest, 1089, Hungary|XIII.ker Onkormanyzat Egeszsegugyi Szolgalat, Budapest, 1139, 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|Azienda ospedaliero-universitaria Mater Domini, Germaneto, Catanzaro, 88100, Italy|Policlinico Univ. Agostino Gemelli, Roma, Lazio, 00168, Italy|Centro Cardiologico Monzino, IRCCS, Milano, MI, 20138, Italy|Azienda Ospedaliera Policlinico Consorziale, Bari, 70124, Italy|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24128, Italy|Ospedale Santa Maria Goretti, Latina, 04100, Italy|Bucheon St. Mary's Hospital, Bucheon,, Gyeonggi-do, 14647, Korea, Republic of|Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 13620, Korea, Republic of|Hanyang University Guri Hospital, Guri-si, Gyeonggido, 11923, Korea, Republic of|Seoul St. Mary's Hospital, Seoul, Korea, 06591, Korea, Republic of|Korea University Ansan Hospital, Ansan-si, 15355, Korea, Republic of|Korea University Anam Hospital, Seoul, 02841, Korea, Republic of|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Severance Hospital Yonsei University Health System, Seoul, 03722, Korea, Republic of|Kyunghee University Hospital at Gangdong, Seoul, 05278, Korea, Republic of|Samsung Medical Center, Seoul, 06351, Korea, Republic of|Ambulatorium Barbara Bazela, Elblag, Warminsko-Mazurki, 82300, Poland|NZOZ ZDROWIE Osteo-Medic, Bialystok, 15-351, Poland|Poradnia Diabetologiczna SN ZOZ Lege Artis, Bialystok, 15-404, Poland|NZOZ Diab-Endo-Met, Krakow, 31-261, Poland|Gabinet Lekarski Malgorzata Saryusz-Wolska, Lodz, 90-132, Poland|Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A., Lodz, 90-242, Poland|NZOZ Przychodnia Specjalistyczna MEDICA, Lublin, 20-538, Poland|NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek, Ruda Slaska, 41-709, Poland|Latin Clinical Trial Center, San Juan, 00909, Puerto Rico|GCM Medical Group PSC, San Juan, 00917, Puerto Rico|San Miguel Medical, Trujillo Alto, 00976, Puerto Rico|S. C. Grandmed S.R.L., Str., Oradea, Bihor, 410159, Romania|Spitalul Judetean de Urgenta Satu Mare, Satu-Mare, Jud Satu-Mare, 440055, Romania|SC Diamed Obesity SRL, Galati, Judetul Galati, 800291, Romania|CMI DNBM Dr. Pop Lavinia, Baia Mare, Maramures, 430222, Romania|Cosamext SRL, Targu Mures, Mures, 540098, Romania|Societatea Civila Medicala "Dr. Paveliu", Bucuresti, Sect.5, 050538, 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|Consultmed SRL, Iasi, 700547, Romania|Hospital Infanta Luisa, Sevilla, Andalucía, 41010, Spain|Hospital Universitario Marques De Valdecilla, Santander, Cantabria, 39011, Spain|Hospital Universitario Quiron Madrid, Pozuelo de Alarcon, Madrid, 28223, Spain|Instituto de Ciencias médicas, Alicante, 03004, Spain|Hospital Clinico Universitario San Cecilio, Granada, 18016, Spain|Clinica Juaneda, Palma de Mallorca, 07014, Spain|Clinica Nuevas Tecnologias en Diabetes y Endocrinologia, Seville, 41003, Spain|Policlinica Galileo, Teruel, 44002, Spain|Changhua Christian Hospital, Changhua, 500, Taiwan|Chang Gung Memorial Hospital - Kaohsiung, Kaohsiung City, 833, Taiwan|Taipei Medical University- Shuang Ho Hospital, New Taipei, 23561, Taiwan|Chung Shan Medical University Hospital, Taichung City, 40201, Taiwan|Kuang Tien General Hospital, Taichung County, 433, Taiwan|Taichung Veterans General Hospital, Taichung, 40705, ROC, Taiwan|Chi-Mei Medical Center, Tainan City, 71004, Taiwan|National Cheng Kung University Hospital, Tainan, 70403, Taiwan|Taipei Veterans General Hospital, Taipei, 11217, Taiwan|Dnipro City Clinical Hospital #9, Dnipro, 49023, Ukraine|V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine, Kyiv, 04114, Ukraine|Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo", Poltava, 36011, Ukraine|Vinnytsia Regional Clinical Highly Specialized Endocrinology Center, Vinnytsia, 21000, Ukraine
URL: https://clinicaltrials.gov/show/NCT03882970

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress