Type 2 Diabetes Clinical Trial
— SURPASS-6Official title:
A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly Versus Insulin Lispro (U100) Three Times Daily in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)
Verified date | October 2023 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.
Status | Completed |
Enrollment | 1428 |
Est. completion date | November 1, 2022 |
Est. primary completion date | October 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Have been diagnosed with type 2 diabetes mellitus (T2DM) - Have HbA1c between =7.5% and =11% - Have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin =1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors - Be of stable weight (± 5%) for at least 90 days - Have a BMI =23 kilograms per meter squared (kg/m²) and =45 kg/m² at screening Exclusion Criteria - Have type 1 diabetes mellitus - Have had chronic or acute pancreatitis any time prior to study entry - Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment - Have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility - Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months - Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 - Have been taking weight loss drugs, including over-the-counter medications during the last 3 months - Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)] |
Country | Name | City | State |
---|---|---|---|
Argentina | Asociación de Beneficencia Hospital Sirio Libanés | Buenos Aires | |
Argentina | Instituto Médico Especializado (IME) | Buenos Aires | |
Argentina | Centro Médico Viamonte | Caba | Buenos Aires |
Argentina | Instituto Centenario | Caba | Buenos Aires |
Argentina | Investigaciones Medicas Imoba Srl | Caba | Buenos Aires |
Argentina | CENUDIAB | Ciudad Autónoma de Buenos Aire | |
Argentina | Centro Diabetologico Dr Waitman | Cordoba | |
Argentina | Centro Medico Privado San Vicente Diabetes | Cordoba | |
Argentina | CIPADI | Godoy Cruz | Mendoza |
Argentina | Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta | Rosario | Buenos Aires |
Argentina | Instituto Médico Catamarca | Rosario | Santa Fe |
Argentina | Sanatorio Parque | Salta | |
Belgium | AZ Damiaan Oostende | Oostende | |
Brazil | Hospital PUC-CAMPINAS | Campinas | São Paulo |
Brazil | Cline Research Center | Curitiba | Paraná |
Brazil | QUANTA - Medicina Nuclear Alto da XV | Curitiba | Paraná |
Brazil | Centro de Pesq. em Diabetes e Doencas Endocrino Metabol. | Fortaleza | Ceará |
Brazil | CECIP - Centro de Estudos do Interior Paulista | Jaú | São Paulo |
Brazil | Centro de Pesquisas em Diabetes | Porto Alegre | Rio Grande Do Sul |
Brazil | Instituto Brasil de Pesquisa Clínica - IBPCLIN | Rio de Janeiro | |
Brazil | CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda | São Bernardo do Campo | São Paulo |
Brazil | ISPEM - Instituto São José dos Campos em Pesquisas Médicas | São José dos Campos | São Paulo |
Brazil | BR Trials - Ensaios Clínicos e Consultoria Ltda | São Paulo | |
Brazil | CEPIC - Centro Paulista de Investigação Clínica | São Paulo | |
Brazil | CPCLIN | São Paulo | SP |
Brazil | CPQuali Pesquisa Clínica | São Paulo | |
Brazil | IPEC - Instituto de Pesquisa Clínica | São Paulo | |
Brazil | CEDOES | Vitoria | ES |
Czechia | Diabetologicka a obezitologicka ambulance | Ceske Budejovice | |
Czechia | Diabetologicka ordinace pro dospele | Krnov | Moravskoslezský Kraj |
Czechia | Diahelp s.r.o., Interni a diabetologicka ambulance | Pardubice | |
Czechia | ResTrial s.r.o. | Praha 8 | |
Germany | InnoDiab Forschung Gmbh | Essen | Nordrhein-Westfalen |
Germany | Medizentrum Essen-Borbeck | Essen | Nordrhein-Westfalen |
Germany | MVZ im Altstadt-Carree Fulda GmbH | Fulda | |
Germany | Diabeteszentrum Hamburg West | Hamburg | |
Germany | Diabetologische Schwerpunktpraxis Harburg | Hamburg | |
Germany | Schwerpunktpraxis für Diabetes | Hof | Bavaria |
Germany | RED-Institut GmbH | Oldenburg | Schleswig-Holstein |
Germany | Zentrum für klinische Studien | Saint Ingbert | Saarland |
Germany | Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf | Wallerfing | |
Greece | Athens Euroclinic | Athens | Attiki |
Greece | General Hospital of Thessaloniki Papageorgiou | N. Efkarpia | Thessaloniki |
Greece | Iatriko Palaiou Falirou, Medical Center | Palaio Faliro | Athens |
Greece | Thermi Clinic | Thermi | Thessaloniki |
Hungary | Szent Margit Rendelointézet Nonprofit Kft | Budapest | |
Hungary | TRANTOR'99 Bt. Anyagcsere Centrum | Budapest | |
Hungary | Belinus Bt | Debrecen | Hajdu-Bihar |
Hungary | Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet | Debrecen | Hajdu-Bihar |
Italy | Policlinico Mater Domini | Germaneto | Catanzaro |
Italy | Ospedale Luigi Sacco | Milano | |
Italy | Policlinico Univ. Agostino Gemelli | Roma | |
Italy | Casa di Cura Multimedica-Policlinico Multispecialistico | Sesto San Giovanni | MI |
Mexico | Instituto Jalisciense de Investigacion en Diabetes y Obesida | Guadalajara | Jalisco |
Mexico | Unidad de patologia Clinica | Guadalajara | Jalisco |
Mexico | Centro de Estudios de Investigacion Metabolicos y Cardiovasculares | Madero | Tamaulipas |
Mexico | Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | N.l. |
Mexico | Centro de Inv. Medica de Occidente, SC | Zapopan | Jalisco |
Puerto Rico | Centro de Endocrinologia y Nutricion del Turabo | Caguas | |
Puerto Rico | Paola Mansilla-Letelier, MD | Guaynabo | |
Romania | CMI DNBM Dr. Pop Lavinia | Baia Mare | Maramures |
Romania | C.M.D.T.A. Neomed | Brasov | Bra?ov |
Romania | Cabinetul Medical Nicodiab SRL | Bucharest | |
Romania | SC Nutrilife SRL | Bucuresti | |
Romania | Milena Sante SRL | Galati | |
Romania | SC Gama Diamed SRL | Mangalia | Constanta |
Romania | S. C. Grandmed S.R.L. | Oradea | Bihor |
Romania | SC Endodigest SRL | Oradea | Bihor |
Romania | SC Diabmed Dr Popescu Alexandrina SRL | Ploiesti | Prahova |
Romania | SC Dianutrilife Medica SRL | Ploiesti | Prahova |
Romania | SC Cosamext SRL | Targu Mures | Mures |
Romania | Centrul Medical Dr. Negrisanu | Timisoara | Timis |
Russian Federation | Arkhangelsk Regional Clinical Hospital | Arkhangelsk | |
Russian Federation | Scientific and Clinical Center for Precision and Regenerative Medicine | Kazan | |
Russian Federation | First Moscow State Medical University | Moscow | |
Russian Federation | Pirogov Russian National Research Medical University | Moscow | |
Russian Federation | SPb GUZ "Diagnostic Center #85" | Saint Petersburg | |
Russian Federation | City Consultative and Diagnostic Center #1 | Saint-Petersburg | |
Russian Federation | Saint-Petersburg State Budgetary Institution of Healthcare Institution | Saint-Petersburg | |
Russian Federation | St.Petersburg Polyclinic #117 | Saint-Petersburg | |
Slovakia | Diacrin s.r.o. | Bratislava | Bratislavský Kraj |
Slovakia | Diabetes care s.r.o. | Hnusta | |
Slovakia | Human care s.r.o. | Kosice | Slovak Republic |
Slovakia | MediVet s.r.o. | Malacky | Bratislavský Kraj |
Slovakia | Areteus s.r.o. | Trebisov | |
Spain | Complejo Hospitalario Universitario De Ferrol - Hospital Naval | Ferrol | La Coruna |
Spain | Clínica Juaneda | Palma de Mallorca | |
Spain | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria |
Spain | Hospital Quiron Infanta Luisa | Sevilla | Andalucía |
Spain | Hospital Universitario Virgen Macarena | Sevilla | |
Turkey | Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi | Adana | |
Turkey | Akdeniz University Medical Faculty | Antalya | |
Turkey | Aydin Adnan Menderes Universitesi | Aydin | |
Turkey | Gaziantep University Medical Faculty | Gaziantep | |
Turkey | Inonu Universitesi | Malatya | |
United States | Albany Medical College | Albany | New York |
United States | University of Colorado | Aurora | Colorado |
United States | Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania |
United States | Excel Medical Clinical Trials | Boca Raton | Florida |
United States | Capital Diabetes and Endocrine Associates | Camp Springs | Maryland |
United States | J H. Stroger Hosp of Cook Co | Chicago | Illinois |
United States | Dallas Diabetes Research Center | Dallas | Texas |
United States | Diabetes and Thyroid Center of Fort Worth | Fort Worth | Texas |
United States | Valley Research | Fresno | California |
United States | Tribe Clinical Research, LLC | Greenville | South Carolina |
United States | I R & Health Center, Inc. | Hialeah | Florida |
United States | Biopharma Informatic, LLC | Houston | Texas |
United States | Juno Research | Houston | Texas |
United States | National Research Institute - Huntington Park | Huntington Park | California |
United States | MedStar Health Research Institute | Hyattsville | Maryland |
United States | Rocky Mountain Clinical Research | Idaho Falls | Idaho |
United States | Glacier View Research Institute - Endocrinology | Kalispell | Montana |
United States | National Research Institute - Huntington Park | Los Angeles | California |
United States | Southern Nh Diabetes and Endocrinology | Nashua | New Hampshire |
United States | Sun Coast Clinical Research, Inc | New Port Richey | Florida |
United States | Intend Research, LLC | Norman | Oklahoma |
United States | North Hills Medical Research | North Richland Hills | Texas |
United States | Valley Clinical Trials, Inc. | Northridge | California |
United States | National Research Institute - Huntington Park | Panorama City | California |
United States | South Broward Research | Pembroke Pines | Florida |
United States | Rainier Clinical Research Center | Renton | Washington |
United States | Endocrine and Metabolic Consultants | Rockville | Maryland |
United States | Texas Diabetes & Endocrinology, P.A. | Round Rock | Texas |
United States | Clinical Trials of Texas, Inc. | San Antonio | Texas |
United States | National Research Institute (NRI) - Santa Ana | Santa Ana | California |
United States | Consano Clinical Research, LLC | Shavano Park | Texas |
United States | Syed Research Consultants Llc | Sheffield | Alabama |
United States | Encompass Clinical Research | Spring Valley | California |
United States | Prairie Education and Research Cooperative | Springfield | Illinois |
United States | Martin Diagnostic Clinic | Tomball | Texas |
United States | University Clinical Investigators, Inc. | Tustin | California |
United States | Preferred Primary Care Physicians | Uniontown | Pennsylvania |
United States | Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa |
United States | Metabolic Research Institute, Inc. | West Palm Beach | Florida |
United States | PMG Research of Wilmington | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, Argentina, Belgium, Brazil, Czechia, Germany, Greece, Hungary, Italy, Mexico, Puerto Rico, Romania, Russian Federation, Slovakia, Spain, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Percentage of Participants Who Achieved Weight Loss =5% | Percentage of Participants who Achieved Weight Loss =5% is reported here. | Week 52 | |
Secondary | 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 | |
Secondary | 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 |
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