Clinical trial NCT04537923: 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
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: glucose-dependent insulinotropic polypeptide (GIP)
glucagon-like peptide-1 (GLP-1)
GIP/GLP-1 dual receptor agonist
T2DM
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-09-03
Enrollment: 1428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 \[for participants on metformin, estimated glomerular filtration rate \<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\]

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Change From Baseline in HbA1c
timeFrame: Baseline, Week 52
measure: Percentage of Participants With HbA1c Target Values <7.0%
timeFrame: Week 52
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Change From Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 52
measure: Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
timeFrame: Baseline, Week 52
measure: Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia
timeFrame: Week 52
measure: Percentage of Participants Who Achieved Weight Loss ≥5%
timeFrame: Week 52
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Syed Research Consultants Llc
state: Alabama
city: Fresno
country: United States
facility: Valley Research
state: California
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Panorama City
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Santa Ana
country: United States
facility: National Research Institute (NRI) - Santa Ana
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: I R & Health Center, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Sun Coast Clinical Research, Inc
state: Florida
city: Pembroke Pines
country: United States
facility: South Broward Research
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Chicago
country: United States
facility: J H. Stroger Hosp of Cook Co
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Camp Springs
country: United States
facility: Capital Diabetes and Endocrine Associates
state: Maryland
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Kalispell
country: United States
facility: Glacier View Research Institute - Endocrinology
state: Montana
city: Nashua
country: United States
facility: Southern Nh Diabetes and Endocrinology
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Beaver
country: United States
facility: Heritage Valley Medical Group, Inc.
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Medical Research
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Caba
country: Argentina
facility: Centro Médico Viamonte
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Buenos Aires
city: Caba
country: Argentina
facility: Instituto Centenario
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta
state: Buenos Aires
city: Godoy Cruz
country: Argentina
facility: CIPADI
state: Mendoza
city: Rosario
country: Argentina
facility: Instituto Médico Catamarca
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto Médico Especializado (IME)
city: Buenos Aires
country: Argentina
facility: Asociación de Beneficencia Hospital Sirio Libanés
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: CENUDIAB
city: Cordoba
country: Argentina
facility: Centro Diabetologico Dr Waitman
city: Cordoba
country: Argentina
facility: Centro Medico Privado San Vicente Diabetes
city: Salta
country: Argentina
facility: Sanatorio Parque
city: Oostende
country: Belgium
facility: AZ Damiaan Oostende
city: Fortaleza
country: Brazil
facility: Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.
state: Ceará
city: Vitoria
country: Brazil
facility: CEDOES
state: ES
city: Curitiba
country: Brazil
facility: Cline Research Center
state: Paraná
city: Curitiba
country: Brazil
facility: QUANTA - Medicina Nuclear Alto da XV
state: Paraná
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisas em Diabetes
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: CPCLIN
state: SP
city: Campinas
country: Brazil
facility: Hospital PUC-CAMPINAS
state: São Paulo
city: Jaú
country: Brazil
facility: CECIP - Centro de Estudos do Interior Paulista
state: São Paulo
city: São Bernardo do Campo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda
state: São Paulo
city: São José dos Campos
country: Brazil
facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Brasil de Pesquisa Clínica - IBPCLIN
city: São Paulo
country: Brazil
facility: IPEC - Instituto de Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: BR Trials - Ensaios Clínicos e Consultoria Ltda
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Krnov
country: Czechia
facility: Diabetologicka ordinace pro dospele
state: Moravskoslezský Kraj
city: Ceske Budejovice
country: Czechia
facility: Diabetologicka a obezitologicka ambulance
city: Pardubice
country: Czechia
facility: Diahelp s.r.o., Interni a diabetologicka ambulance
city: Praha 8
country: Czechia
facility: ResTrial s.r.o.
city: Hof
country: Germany
facility: Schwerpunktpraxis für Diabetes
state: Bavaria
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Medizentrum Essen-Borbeck
state: Nordrhein-Westfalen
city: Saint Ingbert
country: Germany
facility: Zentrum für klinische Studien
state: Saarland
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Fulda
country: Germany
facility: MVZ im Altstadt-Carree Fulda GmbH
city: Hamburg
country: Germany
facility: Diabetologische Schwerpunktpraxis Harburg
city: Hamburg
country: Germany
facility: Diabeteszentrum Hamburg West
city: Wallerfing
country: Germany
facility: Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
city: Palaio Faliro
country: Greece
facility: Iatriko Palaiou Falirou, Medical Center
state: Athens
city: Athens
country: Greece
facility: Athens Euroclinic
state: Attiki
city: N. Efkarpia
country: Greece
facility: General Hospital of Thessaloniki Papageorgiou
state: Thessaloniki
city: Thermi
country: Greece
facility: Thermi Clinic
state: Thessaloniki
city: Debrecen
country: Hungary
facility: Belinus Bt
state: Hajdu-Bihar
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet
state: Hajdu-Bihar
city: Budapest
country: Hungary
facility: Szent Margit Rendelőintézet Nonprofit Kft
city: Budapest
country: Hungary
facility: TRANTOR'99 Bt. Anyagcsere Centrum
city: Germaneto
country: Italy
facility: Policlinico Mater Domini
state: Catanzaro
city: Sesto San Giovanni
country: Italy
facility: Casa di Cura Multimedica-Policlinico Multispecialistico
state: MI
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Roma
country: Italy
facility: Policlinico Univ. Agostino Gemelli
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion en Diabetes y Obesida
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de patologia Clinica
state: Jalisco
city: Zapopan
country: Mexico
facility: Centro de Inv. Medica de Occidente, SC
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: N.l.
city: Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
state: Tamaulipas
city: Caguas
country: Puerto Rico
facility: Centro de Endocrinologia y Nutricion del Turabo
city: Guaynabo
country: Puerto Rico
facility: Paola Mansilla-Letelier, MD
city: Oradea
country: Romania
facility: SC Endodigest SRL
state: Bihor
city: Oradea
country: Romania
facility: S. C. Grandmed S.R.L.
state: Bihor
city: Brasov
country: Romania
facility: C.M.D.T.A. Neomed
state: Brașov
city: Mangalia
country: Romania
facility: SC Gama Diamed SRL
state: Constanta
city: Baia Mare
country: Romania
facility: CMI DNBM Dr. Pop Lavinia
state: Maramures
city: Targu Mures
country: Romania
facility: SC Cosamext SRL
state: Mures
city: Ploiesti
country: Romania
facility: SC Diabmed Dr Popescu Alexandrina SRL
state: Prahova
city: Ploiesti
country: Romania
facility: SC Dianutrilife Medica SRL
state: Prahova
city: Timisoara
country: Romania
facility: Centrul Medical Dr. Negrisanu
state: Timis
city: Bucharest
country: Romania
facility: Cabinetul Medical Nicodiab SRL
city: Bucuresti
country: Romania
facility: SC Nutrilife SRL
city: Galati
country: Romania
facility: Milena Sante SRL
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Hospital
city: Kazan
country: Russian Federation
facility: Scientific and Clinical Center for Precision and Regenerative Medicine
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University
city: Saint Petersburg
country: Russian Federation
facility: SPb GUZ "Diagnostic Center #85"
city: Saint-Petersburg
country: Russian Federation
facility: City Consultative and Diagnostic Center #1
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Institution of Healthcare Institution
city: Saint-Petersburg
country: Russian Federation
facility: St.Petersburg Polyclinic #117
city: Bratislava
country: Slovakia
facility: Diacrin s.r.o.
state: Bratislavský Kraj
city: Malacky
country: Slovakia
facility: MediVet s.r.o.
state: Bratislavský Kraj
city: Kosice
country: Slovakia
facility: Human care s.r.o.
state: Slovak Republic
city: Hnusta
country: Slovakia
facility: Diabetes care s.r.o.
city: Trebisov
country: Slovakia
facility: Areteus s.r.o.
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa
state: Andalucía
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario De Ferrol - Hospital Naval
state: La Coruna
city: Palma de Mallorca
country: Spain
facility: Clínica Juaneda
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Adana
country: Turkey
facility: Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Aydin
country: Turkey
facility: Aydin Adnan Menderes Universitesi
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty
city: Malatya
country: Turkey
facility: Inonu Universitesi
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: