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Clinical Trial Details

Trial ID: L4552
Source ID: NCT03987919
Associated Drug: Tirzepatide
Title: A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes
Acronym: SURPASS-2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03987919/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Tirzepatide|DRUG: Semaglutide
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 Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40 | 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 Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40|Change From Baseline in Body Weight, Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40|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., Week 40|Change From Baseline in Fasting Serum Glucose (FSG), Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40|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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 40|Percentage of Participants Who Achieved Weight Loss ≥5%, Percentage of Participants who Achieved Weight Loss ≥5%., Week 40|Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total 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 40 or early termination. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which 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 with Baseline DTSQs + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares)., Baseline, Week 40|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 HbA1c Group (\<=8.5%, \>8.5%) + Treatment., Baseline through Safety Follow-Up (Up to Week 44)|Percentage of Participants Achieving an HbA1c Target Value of <5.7%, Percentage of Participants Achieving an HbA1c Target Value of \<5.7%., Week 40
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1879
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-07-30
Completion Date: 2021-02-15
Results First Posted: 2022-02-14
Last Update Posted: 2022-02-14
Locations: Cahaba Research, Birmingham, Alabama, 35242, United States|Syed Research Consultants Llc, Sheffield, Alabama, 35660, United States|National Research Institute - Huntington Park, Huntington Park, California, 90255, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|National Research Institute - Huntington Park, Panorama City, California, 91402, United States|Artemis Institute for Clinical Research, Riverside, California, 92503, United States|Artemis Institute for Clinical Research, San Diego, California, 92103, United States|Artemis Institute for Clinical Research, San Marcos, California, 92078, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|CMR of Greater New Haven, Hamden, Connecticut, 06517, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|East Coast Institute for Research at The Jones Center, Lake City, Florida, 32055, United States|South Florida Clinical Research Institute, Margate, Florida, 33063, United States|Suncoast Research Group, Miami, Florida, 33135, United States|New Horizon Research Center, Miami, Florida, 33165 3338, United States|Oviedo Medical Research, Oviedo, Florida, 32765, United States|South Broward Research, Pembroke Pines, Florida, 33027, United States|United Osteoporosis Center, Gainesville, Georgia, 30501, United States|Sky Clinical Research Network, Union City, Georgia, 30291, United States|Elite Clinical Trials, Blackfoot, Idaho, 83221, United States|University of Iowa Hospital & Clinic, Iowa City, Iowa, 52242, United States|Cotton O'Neil Clinic, Topeka, Kansas, 66606, United States|Cotton O'Neil Diabetes and Endocrinology Center, Topeka, Kansas, 66606, United States|NECCR PrimaCare Research, Fall River, Massachusetts, 02721, United States|ActivMed Practices and Research, Methuen, Massachusetts, 01844, United States|Olive Branch Family Medical Center, Olive Branch, Mississippi, 38654, United States|Clinvest Research LLC, Springfield, Missouri, 65810, United States|Premier Research, Trenton, New Jersey, 08611, United States|Albany Medical College, Division of Community Endocrinology, Albany, New York, 12206, United States|PharmQuest, Greensboro, North Carolina, 27408, United States|Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States|PMG Research of Wilmington, Wilmington, North Carolina, 28401, United States|Lillestol Research LLC, Fargo, North Dakota, 58104, United States|Aventiv Research Inc, Columbus, Ohio, 43213, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Capital Area Research, LLC, Camp Hill, Pennsylvania, 17011, United States|Detweiler Family Medicine & Associates, Lansdale, Pennsylvania, 19446, United States|Green & Seidner Family Practice Associates, Lansdale, Pennsylvania, 19446, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States|Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair, Pittsburgh, Pennsylvania, 15243, United States|Holston Medical Group, Bristol, Tennessee, 37620, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Biopharma Informatic, Inc., Houston, Texas, 77043, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Carl R. Meisner Medical Clinic, PLLC, Sugar Land, Texas, 77478, United States|Martin Diagnostic Clinic, Tomball, Texas, 77375, United States|Burke Internal Medicine and Research, Burke, Virginia, 22015, United States|Capital Clinical Research Center, Olympia, Washington, 98502, United States|The Vancouver Clinic, Vancouver, Washington, 98664, United States|CEDIC, Caba, Ar-b, C1425DES, Argentina|CIPREC, Ciudad Autonoma de Buenos Aire, Ar-b, C1119ACN, Argentina|Investigaciones Medicas Imoba Srl, Buenos Aires, Ar-c, C1179AAB, Argentina|CEMEDIAB, C.a.b.a., Ar-c, C1205AAO, Argentina|Sanatorio Norte, Santiago del Estero, Ar-g, 4200, Argentina|Centro de Investigaciones Metabólicas (CINME), Caba, Buenos Aires, C1056ABJ, Argentina|Centro Médico Viamonte, Caba, Buenos Aires, C1120AAC, Argentina|Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada, Caba, Buenos Aires, C1425AGC, Argentina|Mautalen Salud e Investigacion-Centro de Osteopatías Médicas, Ciudad Autonoma De Buenos Air, Buenos Aires, C1128AAF, Argentina|CIPADI, Godoy Cruz, Mendoza, M5501ARP, Argentina|Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata, Provincia De Buenos Aires, (B7600FZN), Argentina|Instituto Centenario, Ciudad Autonoma de Buenos Aire, C1204AAD, Argentina|Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC, Cordoba, X5008HHW, Argentina|Paratus Clinical Research Western Sydney, Blacktown, Au-nsw, 2148, Australia|Campbelltown Medical & Dental Centre, Campbelltown, Au-nsw, 2560, Australia|Paratus Clinical Research Central Coast, Kanwal, Au-nsw, 2259, Australia|Holdsworth House Medical Practice, Sydney, New South Wales, 2010, Australia|GenesisCare - Bundaberg, Bundaberg, Queensland, 4670, Australia|Royal Brisbane and Womens Hospital, Herston, Queensland, 4029, Australia|Core Research Group, Milton, Queensland, 4064, Australia|AusTrials, Taringa, Queensland, 4068, Australia|Eastern Clinical Research Unit, Box Hill, Victoria, 3128, Australia|Barwon Health - The Geelong Hospital, Geelong, Victoria, 3220, Australia|GenesisCare - Wexford Medical Centre WA, Joondalup, Western Australia, 6027, Australia|GenesisCare - Wexford Medical Centre WA, Murdoch, Western Australia, 6150, Australia|Adelaide Medical Solutions, Woodville South, 5011, Australia|CEDOES, Vitória, Br-es, 29055450, Brazil|ISPEM - Instituto São José dos Campos em Pesquisas Médicas, São José dos Campos, Br-sp, 12243-280, Brazil|CPQuali Pesquisa Clínica, São Paulo, Br-sp, 01228-000, Brazil|CEPIC - Centro Paulista de Investigação Clínica, São Paulo, Br-sp, 04266-010, Brazil|Centro de Pesquisas em Diabetes, Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil|CPCLIN, São Paulo, SP, 01228-200, Brazil|Dr. Consulta Clínica Médica LTDA, São Paulo, 05016-090, Brazil|Milestone Research Inc., London, Ca-on, N5W 6A2, Canada|Bluewater Clinical Research Group Inc., Sarnia, Ca-on, N7T 4X3, Canada|Dr. Anil K. Gupta Medicine Professional Corporation, Toronto, Ca-on, M9V 4B4, Canada|Manna Research, Lévis, Ca-qc, G6W 0M5, Canada|Manna Research - Burlington North, Burlington, Ontario, L7M 4Y1, Canada|Manna Research - Burlington North, Nepean, Ontario, K2J 4A7, Canada|Manna Research - Burlington North, Stoney Creek, Ontario, L8J 3W2, Canada|Manna Research - Burlington North, Toronto, Ontario, M9W 4L6, Canada|Meir Medical Center, Kfar Saba, HaMerkaz, 4428164, Israel|Clalit Health Services - Shuali Clinic, Raanana, HaMerkaz, 43405, Israel|Sheba Medical Center, Ramat Gan, HaMerkaz, 5262100, Israel|Diabetes Medical Center, Tel Aviv, Il-ta, 51549, Israel|Hadassah Medical Center, Jerusalem, Yerushalayim, 9112001, Israel|Clalit Health Services - Sakhnin Community Clinic, Sakhnin, 3081000, Israel|Tel Aviv Sourasky Medical Center, Tel Aviv Jaffa, 6423906, Israel|Rambam Health Care Campus, Haifa, Ḥeifā, 3109601, Israel|Linn Medical Center, Haifa, Ḥeifā, 3515209, Israel|Centro Especializado en Diabetes Obesidad y Enfermedades, Mexico, D.f., 11650, Mexico|Diseno y Planeacion en Investigacion Medica, Guadalajara, Jalisco, 44130, Mexico|Instituto Jalisciense de Investigacion en Diabetes y Obesida, Guadalajara, Jalisco, 44600, Mexico|Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente, Guadalajara, Mx-jal, 44150, Mexico|Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, N.l., 64460, Mexico|Unidad Médica para la Salud Integral, San Nicolás de los Garza, Nuevo León, 66465, Mexico|Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, Ciudad Madero, Tamaulipas, 89440, Mexico|Investigacion en Salud y Metabolismo S.C, Chihuahua, 31238, Mexico|Paola Mansilla-Letelier, MD, Guaynabo, 00970, Puerto Rico|Research and Cardiovascular Corp., Ponce, 00717, Puerto Rico|Clinical Research Puerto Rico, San Juan, 00909, Puerto Rico|Martha Gomez Cuellar M.D., San Juan, 00921, Puerto Rico|Oldfield Surgery, Bath, Avon, BA2 3HT, United Kingdom|Staploe Medical Centre, Ely, Gb-cam, CB7 5JD, United Kingdom|Fowey River Practice, Fowey, Gb-con, PL23 1DT, United Kingdom|Oak Tree Surgery, Liskeard, Gb-con, PL14 3XA, United Kingdom|Rame Medical Ltd, Torpoint, Gb-con, PL11 2TB, United Kingdom|Royal Primary Care Chesterfield North west, Chesterfield, Gb-dby, S40 4AA, United Kingdom|Knowle House Surgery, Plymouth, Gb-dev, PL5 3JB, United Kingdom|Queen Alexandra Hospital, Portsmouth, Gb-ham, PO6 3LY, United Kingdom|Lister Hospital, Stevenage, Gb-hrt, SG1 4AB, United Kingdom|Oakenhurst Medical Practice, Blackburn, Gb-lan, BB2 1AX, United Kingdom|Rowden Surgery, cHIPPENHAM, Gb-wil, SN15 2SB, United Kingdom|Leicester General Hospital, Leicester, Leicestershire, LE5 4PW, United Kingdom|University Hospital Coventry & Warwickshire, Coventry, Warwickshire, CV2 2DX, United Kingdom|Wickersley Health Centre - Clifton Medical Centre, Rotherham, S65 1DA, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03987919

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress