Eine Studie von Tirzepatid (LY3298176) gegen Insulin Lispro (U100) bei Typ mit 2-Diabetes, die mit Insulin Glargin (U100) mit oder ohne Metformin gehörtend erhalten wurde

Eine randomisierte, offene Phase-3-Studie, in der Wirkung der von Tirzepatid einmal verlässlich mit Insulin Lispro (U100), mit Insulin Glargin (U100) oder ohne Metformin (SURPASS-6)

Sponsoren

Hauptsponsor: Eli Lilly and Company

Quelle Eli Lilly and Company
Kurze Zusammenfassung

Der Zweck dieser Studie ist es, die Sicherheit und die Wahrnehmung der Studienmedikamente Tirzepatid zu vergleichen Unterschiedliches Insulin lispro (U100) bei Typ mit Typ-2-Diabetes bereits auf Insulin glargin (U100), mit oder ohne Metformin.

Gesamtstatus Verwirklichung
Anfangsdatum 2020-10-19
Fertigstellungstermin 2022-09-19
Primäres Abschlussdatum 2022-08-19
Phase Phase 3
Studientyp Interventionell
Primärer Ausgang
Messen Zeitfenster
Änderung des Hämoglobins A1c (HbA1c) gegenüber dem Ausgangswert (gepoolte Dosen) Baseline, Woche 52
Sekundäres Ergebnis
Messen Zeitfenster
Change from Baseline in HbA1c (Individual Doses) Baseline, Week 52
Prozentsatz der Teilnehmer mit HbA1c-Zielwerten Woche 52
Änderung des Körpergewichts gegenüber dem Ausgangswert Baseline, Woche 52
Änderung der Nüchtern-Serumglukose gegenüber dem Ausgangswert Baseline, Woche 52
Mittlere Änderung der täglichen durchschnittlichen selbstüberwachten 7-Punkte-Blutzuckerwerte (SMBG) gegenüber dem Ausgangswert Baseline, Woche 52
Prozentsatz der Teilnehmer, die den HbA1c-Zielwert von erreicht haben Woche 52
Prozentsatz der Teilnehmer, die einen Gewichtsverlust von ≥ 5% erreicht haben Woche 52
Änderung des Ausgangswerts in der 36-Punkte-Kurzform-Gesundheitsumfrage (SF-36) für die Zusammenfassung der physischen Komponenten (PCS) Baseline, Woche 52
Änderung des MCS-Scores (Mental Component Summary) mit 36 ​​Elementen gegenüber dem Ausgangswert Baseline, Woche 52
Einschreibung 1182
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Tirzepatide

Beschreibung: Administered SC

Anderer Name: LY3298176

Interventionsart: Arzneimittel

Interventionsname: Insulin Lispro (U100)

Beschreibung: Verwalteter SC

Armgruppenetikett: Insulin Lispro (U100)

Anderer Name: LY275585

Interventionsart: Arzneimittel

Interventionsname: Insulin Glargin (U100)

Beschreibung: Verwalteter SC

Teilnahmeberechtigung

Kriterien:

Einschlusskriterien: - Bei Ihnen wurde Typ-2-Diabetes mellitus (T2DM) genommen. - HbA1c zwischen ≥7,5% und ≤11% haben - Wurden vor dem Screening mindestens 90 Tage lang ein- oder gleichberechtigt Tägliches Basalinsulin mit oder ohne stabile Dosis von Metformin ≥ 1500 mg / Tag und bis zu Maximaler Kontakte Dosis pro ländererklärungsbewusster Etikett, Sulfonylharnstoffe oder Dipeptidyl Peptidase 4-Inhibitoren - Mindestens 90 Tage lang ein stabiles Gewicht (± 5%) haben - Haben Sie einen BMI ≥ 23 Kilogramm pro Kraft (kg / m²) und ≤ 45 kg / m² beim Screening Ausschlusskriterien - Typ-1-Diabetes mellitus haben - Sie hatten bereits vor Studienbeginn eine chronische oder akute Pankreatitis - Proliferative diabetische Retinopathie oder diabetisches Makulaödem oder nicht proliferativ haben diabetische Retinopathie - Störungen im Zusammenhang mit einer verlangsamten Magenentleerung haben, Magenprobleme hatten Operationen zum Zweck der Gewichtsabnahme oder nehmen chronisch genommen, sterben direkt die gastrointestinale Motmäßige Verwaltung - Sie hatten einen Herzinfarkt, einen Zugang oder einen Krankenhausaufenthalt wegen Herzinsuffizienz in die letzten 2 Monate - Sie haben eine persönliche oder familiäre Vorgeschichte eines medullären Schilddrüsenkarzinoms oder eine persönliche Vorgeschichte des multiplen endokrinen Neoplasie-Syndroms Typ 2 - unterscheiden der Wahrnehmung von Verträgen zur Qualitätsreduktion, haben rezeptfreier Verträge, eständige haben letzte 3 Monate - Haben Sie eine falschete glomeruläre Filtrationsrate

Geschlecht:

Alle

Mindestalter:

18 Jahre

Maximales Alter:

N / A

Gesunde Freiwillige:

Nein

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company
Gesamtkontakt

Nachname: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Telefon: 1-317-615-4559

Email: [email protected]

Ort
Einrichtung: Status: Kontakt: Ermittler:
Syed Research Consultants Llc | Sheffield, Alabama, 35660, United States Recruiting 256-383-4473 Aaron Karr Principal Investigator
Valley Research | Fresno, California, 93720, United States Recruiting 5592610992 Paul Carlton Norwood Principal Investigator
National Research Institute - Huntington Park | Huntington Park, California, 90255, United States Recruiting 323-588-1968 Stanley H. Hsia Principal Investigator
National Research Institute - Huntington Park | Los Angeles, California, 90057, United States Recruiting 2134132500 Juan Pablo Frias Principal Investigator
Valley Clinical Trials, Inc. | Northridge, California, 91325, United States Recruiting 818-280-4220 Christopher Chow Principal Investigator
National Research Institute - Huntington Park | Panorama City, California, 91402, United States Recruiting 8185326880 Robert Allen Jenders Principal Investigator
National Research Institute (NRI) - Santa Ana | Santa Ana, California, 92704, United States Recruiting 714-599-8711 Mark T. Leibowitz Principal Investigator
Encompass Clinical Research | Spring Valley, California, 91978, United States Recruiting 619-660-9068 Hanid Audish Principal Investigator
University Clinical Investigators, Inc. | Tustin, California, 92780, United States Recruiting 714-734-7944 Joanna T. Van Principal Investigator
University of Colorado | Aurora, Colorado, 80045, United States Recruiting 720-848-7174 Neda Rasouli Principal Investigator
Excel Medical Clinical Trials | Boca Raton, Florida, 33434, United States Recruiting 561-756-8206 Seth J. Baum Principal Investigator
I R & Health Center, Inc. | Hialeah, Florida, 33012, United States Recruiting 305-825-6588 Jose F Cardona Principal Investigator
Sun Coast Clinical Research, Inc | New Port Richey, Florida, 34652, United States Recruiting 727-849-4131 Antonio Pinero-Pilona Principal Investigator
South Broward Research | Pembroke Pines, Florida, 33027, United States Recruiting 954-433-5867 Kenneth Blaze Principal Investigator
Metabolic Research Institute, Inc. | West Palm Beach, Florida, 33401, United States Recruiting 5618023060 Barry Scot Horowitz, MD Principal Investigator
Rocky Mountain Clinical Research | Idaho Falls, Idaho, 83404, United States Recruiting 208-522-6005 Carl D Vance Principal Investigator
J H. Stroger Hosp of Cook Co | Chicago, Illinois, 60612, United States Recruiting 312-864-6733 Leon Fogelfeld Principal Investigator
Prairie Education and Research Cooperative | Springfield, Illinois, 62711, United States Recruiting 217-787-8870 Diana Widicus Principal Investigator
Iowa Diabetes and Endocrinology Research Center | West Des Moines, Iowa, 50265, United States Recruiting 515-329-6800 Anuj Bhargava Principal Investigator
Capital Diabetes and Endocrine Associates | Camp Springs, Maryland, 20746, United States Recruiting 833-254-6829 Romeu Azevedo Principal Investigator
MedStar Health Research Institute | Hyattsville, Maryland, 20782, United States Recruiting 3015602987 Jean Young Park Principal Investigator
Endocrine and Metabolic Consultants | Rockville, Maryland, 20852, United States Recruiting 301-770-7373 Helena W. Rodbard Principal Investigator
Billings Clinic | Billings, Montana, 59101, United States Recruiting 406-435-8473 Haleigh James Principal Investigator
Glacier View Research Institute - Endocrinology | Kalispell, Montana, 59901, United States Recruiting 406-751-4171 Jose de Souza Principal Investigator
Southern Nh Diabetes and Endocrinology | Nashua, New Hampshire, 03060, United States Recruiting 6035777574 Robert Jeffrey Silver Principal Investigator
Albany Medical College | Albany, New York, 12203, United States Recruiting 518-461-9734 Robert Busch Principal Investigator
ECU Nephrology and Hypertension | Greenville, North Carolina, 27834, United States Recruiting 252-744-2795 Basem Mishriky Principal Investigator
PMG Research of Wilmington | Wilmington, North Carolina, 28401, United States Recruiting 9108156108 John Charles Parker Principal Investigator
Intend Research, LLC | Norman, Oklahoma, 73069, United States Recruiting 405-701-8999 Lisa Connery Principal Investigator
Heritage Valley Medical Group, Inc. | Beaver, Pennsylvania, 15009, United States Recruiting 724-774-7743 Michael J Oliver Principal Investigator
Preferred Primary Care Physicians | Uniontown, Pennsylvania, 15401, United States Recruiting 724-912-0033 Paul A. Hartley Principal Investigator
Tribe Clinical Research, LLC | Greenville, South Carolina, 29607, United States Recruiting 8643340141 Ronald Keith Mayfield Principal Investigator
Dallas Diabetes Research Center | Dallas, Texas, 75230, United States Recruiting 972-566-2376 Julio Rosenstock Principal Investigator
Diabetes and Thyroid Center of Fort Worth | Fort Worth, Texas, 76132, United States Recruiting 817-263-0007 Anjanette Tan Principal Investigator
Juno Research | Houston, Texas, 77040, United States Recruiting 713-779-5494 Damaris Vega Principal Investigator
Biopharma Informatic, Inc. | Houston, Texas, 77043, United States Recruiting 2817685879 Donald Franklin Gardner Principal Investigator
North Hills Medical Research | North Richland Hills, Texas, 76180, United States Recruiting 817-595-3399 John Gabriel Principal Investigator
Texas Diabetes & Endocrinology, P.A. | Round Rock, Texas, 78681, United States Recruiting 512-334-3505 Kerem Ozer Principal Investigator
Clinical Trials of Texas, Inc. | San Antonio, Texas, 78229, United States Recruiting 2109490122 Douglas Scott Denham Principal Investigator
Consano Clinical Research, LLC | Shavano Park, Texas, 78231, United States Recruiting 210-545-4900 Michelle Welch Principal Investigator
Martin Diagnostic Clinic | Tomball, Texas, 77375, United States Recruiting 281-517-0550 Earl E Martin Principal Investigator
Rainier Clinical Research Center | Renton, Washington, 98057, United States Recruiting 425-251-1720 Leslie J Klaff Principal Investigator
Centro Médico Viamonte | Caba, Buenos Aires, C1120AAC, Argentina Recruiting 541149635650 Diego Aizenberg Principal Investigator
Investigaciones Medicas Imoba Srl | Caba, Buenos Aires, C1179AAB, Argentina Recruiting 541149831589 Silvia Inés Orio Principal Investigator
Fundacion Sanatorio Guemes | Caba, Buenos Aires, C1180AAX, Argentina Not yet recruiting 541149598319 Hernan Dario Finkelstein Principal Investigator
Instituto Centenario | Caba, Buenos Aires, C1204AAD, Argentina Recruiting 541149810256 Susana Salzberg Principal Investigator
CENUDIAB | Ciudad Autónoma de Buenos Aire, Buenos Aires, C1440AAD, Argentina Recruiting 541146820269 Alejandra Oviedo Principal Investigator
Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta | Rosario, Buenos Aires, S2000BIF, Argentina Recruiting 543414473997 Maximiliano Sicer Principal Investigator
CIPADI | Godoy Cruz, Mendoza, M5501ARP, Argentina Recruiting 542614200345 Pedro Rosario Fabian Calella Principal Investigator
Instituto Médico Catamarca | Rosario, Santa Fe, 2000, Argentina Recruiting 543412985581 Natacha Maldonado Principal Investigator
Instituto Médico Especializado (IME) | Buenos Aires, 1405, Argentina Recruiting 49039777 Patricia Castaño Principal Investigator
Asociación de Beneficencia Hospital Sirio Libanés | Buenos Aires, C1419AHN, Argentina Recruiting 541145740870 Gustavo Daniel Frechtel Principal Investigator
Centro Diabetologico Dr Waitman | Cordoba, 5000, Argentina Recruiting 543514245162 Silvana Ernestina Solis Principal Investigator
Centro Medico Privado San Vicente Diabetes | Cordoba, X5006CBI, Argentina Recruiting 543514558041 Cecilia Mónica Luquez Principal Investigator
Sanatorio Parque | Salta, 4400, Argentina Recruiting 03874318800 Silvia Saavedra Principal Investigator
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven, Flemish Brabant, 3000, Belgium Recruiting 003216348554 Ann Mertens Principal Investigator
AZ Nikolaas, Campus Moerland | Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium Recruiting 003237602252 Peter Coremans Principal Investigator
AZ Groeninge | Kortrijk, 8500, Belgium Recruiting 003256633188 Gerd Vanhaverbeke Principal Investigator
AZ Damiaan Oostende | Oostende, 8400, Belgium Recruiting 003259414166 Linsey Winne Principal Investigator
Centro de Pesq. em Diabetes e Doencas Endocrino Metabol. | Fortaleza, Ceará, 60430-350, Brazil Recruiting 558530327044 Miguel Nasser Hissa Principal Investigator
CEDOES | Vitoria, ES, 29055-450, Brazil Recruiting 552721250220 Queulla Garret Ramos Santos Principal Investigator
Cline Research Center | Curitiba, Paraná, 80030, Brazil Recruiting 554130273930 Silmara Aparecida de Oliveira Leite Principal Investigator
QUANTA - Medicina Nuclear Alto da XV | Curitiba, Paraná, 80045-170, Brazil Recruiting 554132628040 Rosangela Rea Principal Investigator
Centro de Pesquisas em Diabetes | Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil Recruiting 555132684276 Luis Henrique Santos Canani Principal Investigator
Hospital de Base de Sao Jose do Rio Preto | Sao Jose do Rio Preto, Sao Paulo, 15090-000, Brazil Recruiting 551732015054 Fabio Guirado Dias Principal Investigator
CPCLIN | São Paulo, SP, 01228-200, Brazil Recruiting 551127110251 Denise Reis Franco Principal Investigator
Hospital PUC-CAMPINAS | Campinas, São Paulo, 13060-904, Brazil Recruiting 551933438526 Danilo Glauco Pereira Villagelin Neto Principal Investigator
CECIP - Centro de Estudos do Interior Paulista | Jaú, São Paulo, 17201-130, Brazil Recruiting 5514981169078 Octavio de Marques Freitas Morato Principal Investigator
CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda | São Bernardo do Campo, São Paulo, 09715-090, Brazil Recruiting 551143176051 Claudia de Brito Principal Investigator
ISPEM - Instituto São José dos Campos em Pesquisas Médicas | São José dos Campos, São Paulo, 12243-280, Brazil Recruiting 551239131789 Márcio Antonio Pereira Principal Investigator
Instituto Brasil de Pesquisa Clínica - IBPCLIN | Rio de Janeiro, 20241180, Brazil Recruiting 552125277979 Joselita Siqueira Principal Investigator
IPEC - Instituto de Pesquisa Clínica | São Paulo, 01223-001, Brazil Recruiting 551127370277 Joao Eduardo Nunes Salles Principal Investigator
CPQuali Pesquisa Clínica | São Paulo, 01228-000, Brazil Recruiting 551127766801 Gustavo Akerman Augusto Principal Investigator
BR Trials - Ensaios Clínicos e Consultoria Ltda | São Paulo, 03325-050, Brazil Recruiting 551126722734 Bruno Halpern Principal Investigator
CEPIC - Centro Paulista de Investigação Clínica | São Paulo, 04266-010, Brazil Recruiting 551122713466 Breno Balabem Alves Principal Investigator
Diabetologicka ordinace pro dospele | Krnov, Moravskoslezský Kraj, 79401, Czechia Recruiting 00420554611468 Tomas Edelsberger Principal Investigator
Diabetologicka a obezitologicka ambulance | Ceske Budejovice, 370 11, Czechia Recruiting 00420720227013 Alena Vachova Principal Investigator
Diahelp s.r.o., Interni a diabetologicka ambulance | Pardubice, 530 02, Czechia Recruiting 00420466753365 Juraj Divinec Principal Investigator
ResTrial s.r.o. | Praha 8, 181 00, Czechia Recruiting 00420257211920 Emilia Malicherova Principal Investigator
Schwerpunktpraxis für Diabetes | Hof, Bavaria, 95030, Germany Recruiting 0049928114037027 Mesut Durmaz Principal Investigator
InnoDiab Forschung Gmbh | Essen, Nordrhein-Westfalen, 45136, Germany Recruiting 004920189942100 Helga Zeller Principal Investigator
Medizentrum Essen-Borbeck | Essen, Nordrhein-Westfalen, 45355, Germany Recruiting 0049201866440 Axel Schaefer Principal Investigator
Praxis Dr. Segiet | Speyer, Rheinland-Pfalz, 67346, Germany Recruiting 00496232699950 Thomas Segiet Principal Investigator
Zentrum für klinische Studien | Saint Ingbert, Saarland, 66386, Germany Recruiting 00496894998810 Alexander Segner Principal Investigator
RED-Institut GmbH | Oldenburg, Schleswig-Holstein, 23758, Germany Recruiting 0049436150630128 Thomas Schaum Principal Investigator
MVZ im Altstadt-Carree Fulda GmbH | Fulda, 36037, Germany Recruiting 004966125035110 Jörg Simon Principal Investigator
Diabetologische Schwerpunktpraxis Harburg | Hamburg, 21073, Germany Recruiting 004940557753300 Bjoern Paschen Principal Investigator
Diabeteszentrum Hamburg West | Hamburg, 22607, Germany Recruiting 004940896295 Dominik Dahl Principal Investigator
Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf | Wallerfing, 94574, Germany Recruiting 004999361315 Josef Großkopf Principal Investigator
Iatriko Palaiou Falirou, Medical Center | Palaio Faliro, Athens, 17562, Greece Recruiting 00302109892300 Ioannis Doupis Principal Investigator
Athens Euroclinic | Athens, Attiki, 11521, Greece Recruiting 302106416600 Mariana Benroubi Principal Investigator
General Hospital of Thessaloniki Papageorgiou | N. Efkarpia, Thessaloniki, 56403, Greece Recruiting 302310693256 Glykeria Tzatzagou Principal Investigator
Thermi Clinic | Thermi, Thessaloniki, 57001, Greece Recruiting 00302310024800 Emmanouil Pagkalos Principal Investigator
Belinus Bt | Debrecen, Hajdu-Bihar, 4025, Hungary Recruiting 0036702459609 Sandor Vangel Principal Investigator
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet | Debrecen, Hajdu-Bihar, 4032, Hungary Recruiting 003652255525 Denes Pall Principal Investigator
Szent Margit Rendelointezet | Budapest, 1032, Hungary Recruiting 003613889180-133 Eleonora Beke Principal Investigator
TRANTOR'99 Bt. Anyagcsere Centrum | Budapest, 1213, Hungary Recruiting 003612760708 Ildiko Szatmari Principal Investigator
Policlinico Mater Domini | Germaneto, Catanzaro, 88100, Italy Recruiting 003909613647039 Agostino Gnasso Principal Investigator
Casa di Cura Multimedica-Policlinico Multispecialistico | Sesto San Giovanni, MI, 20099, Italy Recruiting 00390224209237 Cesare Berra Principal Investigator
Policlinico S. Orsola Malpighi - Universita di Bologna | Bologna, 40138, Italy Recruiting 00390512143634 Uberto Pagotto Principal Investigator
Ospedale Luigi Sacco | Milano, 20157, Italy Recruiting 00390250319819 Paolo Fiorina Principal Investigator
Policlinico Univ. Agostino Gemelli | Roma, 00168, Italy Recruiting 00390630154071 Dario Pitocco Principal Investigator
Instituto Jalisciense de Investigacion en Diabetes y Obesida | Guadalajara, Jalisco, 44600, Mexico Recruiting 013311991124 Guillermo González Gálvez Principal Investigator
Unidad de patologia Clinica | Guadalajara, Jalisco, 44650, Mexico Not yet recruiting 523336165410 Maria del Rosario Arechavaleta Granell Principal Investigator
Centro de Inv. Medica de Occidente, SC | Zapopan, Jalisco, 45116, Mexico Recruiting 523312044280 Susana Emilia Pelayo Orozco Principal Investigator
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey, N.l., 64460, Mexico Recruiting 528183465540 Jose Gerardo Gonzalez-Gonzalez Principal Investigator
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares | Madero, Tamaulipas, 89440, Mexico Recruiting 528332142554 Rafael Margarito Violante Ortiz Principal Investigator
Centro de Endocrinologia y Nutricion del Turabo | Caguas, 00726, Puerto Rico Recruiting 7877467057 Juan R Otero-Martinez Principal Investigator
Paola Mansilla-Letelier, MD | Guaynabo, 00970, Puerto Rico Recruiting 7874000333 Paola Mansilla-Letelier Principal Investigator
SC Endodigest SRL | Oradea, Bihor, 410151, Romania Active, not recruiting
S. C. Grandmed S.R.L. | Oradea, Bihor, 410159, Romania Recruiting 0040722691962 Adriana Gabriela Onaca Principal Investigator
SC Gama Diamed SRL | Mangalia, Constanta, 905500, Romania Recruiting 0040722281032 Amalia Thury-Burileanu Principal Investigator
CMI DNBM Dr. Pop Lavinia | Baia Mare, Maramures, 430222, Romania Recruiting 0040735867270 Lavinia Pop Principal Investigator
SC Cosamext SRL | Targu Mures, Mures, 540098, Romania Recruiting 0040745641194 Daniela Elena Ciomos Principal Investigator
SC Diabmed Dr Popescu Alexandrina SRL | Ploiesti, Prahova, 100179, Romania Recruiting 0040244523484 Alexandrina Popescu Principal Investigator
SC Dianutrilife Medica SRL | Ploiesti, Prahova, 100561, Romania Recruiting 0040745761212 Bogdan Popa Principal Investigator
Centrul Medical Dr. Negrisanu | Timisoara, Timis, 300456, Romania Recruiting 0040256240609 Gabriela Doina Negrisanu Principal Investigator
SC CMDTA Neomed SRL | Brasov, 500283, Romania Recruiting 0040368424168 Valentina Neacsu Principal Investigator
Cabinetul Medical Nicodiab SRL | Bucharest, 010507, Romania Recruiting 0040212116046 Nicoleta Mihaela Mindrescu Principal Investigator
SC Nutrilife SRL | Bucuresti, 013671, Romania Recruiting 0040212323445 Marlena Pascu Principal Investigator
Milena Sante SRL | Galati, 800001, Romania Recruiting 0040236464546 Cristina Mistodie Principal Investigator
Arkhangelsk Regional Clinical Hospital | Arkhangelsk, 163045, Russian Federation Recruiting 0078182 636363 Svetlana Ivanova Principal Investigator
Scientific and Clinical Center for Precision and Regenerative Medicine | Kazan, 420012, Russian Federation Recruiting 0078432367892 Leylya Gaysina Principal Investigator
Pirogov Russian National Research Medical University | Moscow, 109263, Russian Federation Recruiting 0074995313040 Tatiana Demidova Principal Investigator
First Moscow State Medical University | Moscow, 119435, Russian Federation Recruiting 0074992486477 Alexey V Zilov Principal Investigator
SPb GUZ "Diagnostic Center #85" | Saint Petersburg, 198255, Russian Federation Recruiting 0078127521371 Olga A Miroshnichenko Principal Investigator
City Consultative and Diagnostic Center #1 | Saint-Petersburg, 194354, Russian Federation Recruiting 0078122963500 Irina Karpova Principal Investigator
Saint-Petersburg State Budgetary Institution of Healthcare Institution | Saint-Petersburg, 194354, Russian Federation Recruiting 0078123384888 Alsu Zalevskaya Principal Investigator
St.Petersburg Polyclinic #117 | Saint-Petersburg, 194358, Russian Federation Recruiting 0078124977314 Diana Alpenidze Principal Investigator
Human care s.r.o. | Kosice, Slovak Republic, 04012, Slovakia Recruiting 00421905667695 Viera Donicova Principal Investigator
MediVet s.r.o. | Malacky, Slovak Republic, 90101, Slovakia Recruiting 00421347723225 Eva Pavleova Principal Investigator
Areteus s.r.o. | Trebisov, Slovak Republic, 07501, Slovakia Recruiting 00421566716115 Dasa Skripova Principal Investigator
Diacrin s.r.o. | Bratislava, 84102, Slovakia Recruiting 00421915311689 Eva Zakovicova Principal Investigator
Diabetes care s.r.o. | Hnusta, 98101, Slovakia Recruiting 00421475424379 Jana Horvath-Bercikova Principal Investigator
Hospital Quiron Infanta Luisa | Sevilla, Andalucía, 41010, Spain Recruiting 0034954001856 MARGARITA RIVAS FERNANDEZ Principal Investigator
Hospital Universitario Marques De Valdecilla | Santander, Cantabria, 39011, Spain Recruiting 0034639659866 Luis Vazquez Principal Investigator
Hospital Naval de Ferrol | Ferrol, La Coruna, 15405, Spain Recruiting 0034981336885 DIEGO BELLIDO GUERRERO Principal Investigator
Clinica Juaneda | Palma de Mallorca, 07014, Spain Recruiting 0034971175000 Santiago Tofe Povedano Principal Investigator
Hospital Universitario Virgen Macarena | Sevilla, 41009, Spain Recruiting 0034955693429 Cristobal Jesus Morales Portillo Principal Investigator
Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi | Adana, 01240, Turkey Recruiting 00905333208241 Okan Bakiner Principal Investigator
Akdeniz University Medical Faculty | Antalya, 07059, Turkey Recruiting 00905337670913 Ramazan Sari Principal Investigator
Aydin Adnan Menderes Universitesi | Aydin, 09010, Turkey Recruiting 00905340122400 Mustafa Unubol Principal Investigator
Gaziantep University Medical Faculty | Gaziantep, 27310, Turkey Recruiting 00905345471118 Mustafa Araz Principal Investigator
Dokuz Eylul University Hospital | Izmir, 35340, Turkey Recruiting 00905454219926 Abdurrahman Comlekci Principal Investigator
Inonu University Medical Faculty | Malatya, 44282, Turkey Recruiting 00905324871453 Ibrahim Sahin Principal Investigator
Standort Länder

Argentina

Belgium

Brazil

Czechia

Germany

Greece

Hungary

Italy

Mexico

Puerto Rico

Romania

Russian Federation

Slovakia

Spain

Turkey

United States

Überprüfungsdatum

2021-05-01

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert Nein
Anzahl der Waffen 4
Armgruppe

Etikette: 5 mg Tirzepatide

Art: Experimental

Beschreibung: 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week with insulin glargine (U100) administered SC.

Etikette: 10 mg Tirzepatid

Art: Experimental

Beschreibung: 10 mg Tirzepatid verabreichten SC einmal pro Woche mit Insulin Glargin (U100) verabreichtem SC.

Etikette: 15 mg Tirzepatid

Art: Experimental

Beschreibung: 15 mg Tirzepatid verabreichten SC einmal pro Woche mit Insulin Glargin (U100) verabreichtem SC.

Etikette: Insulin Lispro (U100)

Art: Aktiver Komparator

Beschreibung: Insulin lispro (U100) verabreichte SC dreimal täglich mit Insulin glargin (U100) verabreichtem SC.

Akronym SURPASS-6
Studiendesign Info

Zuweisung: Zufällig

Interventionsmodell: Parallele Zuordnung

Hauptzweck: Behandlung

Maskierung: Keine (Open Label)

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