Back to resultsA Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Insulin Lispro (U100)
Insulin Glargine (U100)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist, T2DM
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)]
Sites / Locations
- Syed Research Consultants Llc
- Valley Research
- National Research Institute - Huntington Park
- National Research Institute - Huntington Park
- Valley Clinical Trials, Inc.
- National Research Institute - Huntington Park
- National Research Institute (NRI) - Santa Ana
- Encompass Clinical Research
- University Clinical Investigators, Inc.
- University of Colorado
- Excel Medical Clinical Trials
- I R & Health Center, Inc.
- Sun Coast Clinical Research, Inc
- South Broward Research
- Metabolic Research Institute, Inc.
- Rocky Mountain Clinical Research
- J H. Stroger Hosp of Cook Co
- Prairie Education and Research Cooperative
- Iowa Diabetes and Endocrinology Research Center
- Capital Diabetes and Endocrine Associates
- MedStar Health Research Institute
- Endocrine and Metabolic Consultants
- Glacier View Research Institute - Endocrinology
- Southern Nh Diabetes and Endocrinology
- Albany Medical College
- PMG Research of Wilmington
- Intend Research, LLC
- Heritage Valley Medical Group, Inc.
- Preferred Primary Care Physicians
- Tribe Clinical Research, LLC
- Dallas Diabetes Research Center
- Diabetes and Thyroid Center of Fort Worth
- Juno Research
- Biopharma Informatic, LLC
- North Hills Medical Research
- Texas Diabetes & Endocrinology, P.A.
- Clinical Trials of Texas, Inc.
- Consano Clinical Research, LLC
- Martin Diagnostic Clinic
- Rainier Clinical Research Center
- Centro Médico Viamonte
- Investigaciones Medicas Imoba Srl
- Instituto Centenario
- Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta
- CIPADI
- Instituto Médico Catamarca
- Instituto Médico Especializado (IME)
- Asociación de Beneficencia Hospital Sirio Libanés
- CENUDIAB
- Centro Diabetologico Dr Waitman
- Centro Medico Privado San Vicente Diabetes
- Sanatorio Parque
- AZ Damiaan Oostende
- Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.
- CEDOES
- Cline Research Center
- QUANTA - Medicina Nuclear Alto da XV
- Centro de Pesquisas em Diabetes
- CPCLIN
- Hospital PUC-CAMPINAS
- CECIP - Centro de Estudos do Interior Paulista
- CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda
- ISPEM - Instituto São José dos Campos em Pesquisas Médicas
- Instituto Brasil de Pesquisa Clínica - IBPCLIN
- IPEC - Instituto de Pesquisa Clínica
- CPQuali Pesquisa Clínica
- BR Trials - Ensaios Clínicos e Consultoria Ltda
- CEPIC - Centro Paulista de Investigação Clínica
- Diabetologicka ordinace pro dospele
- Diabetologicka a obezitologicka ambulance
- Diahelp s.r.o., Interni a diabetologicka ambulance
- ResTrial s.r.o.
- Schwerpunktpraxis für Diabetes
- InnoDiab Forschung Gmbh
- Medizentrum Essen-Borbeck
- Zentrum für klinische Studien
- RED-Institut GmbH
- MVZ im Altstadt-Carree Fulda GmbH
- Diabetologische Schwerpunktpraxis Harburg
- Diabeteszentrum Hamburg West
- Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
- Iatriko Palaiou Falirou, Medical Center
- Athens Euroclinic
- General Hospital of Thessaloniki Papageorgiou
- Thermi Clinic
- Belinus Bt
- Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet
- Szent Margit Rendelőintézet Nonprofit Kft
- TRANTOR'99 Bt. Anyagcsere Centrum
- Policlinico Mater Domini
- Casa di Cura Multimedica-Policlinico Multispecialistico
- Ospedale Luigi Sacco
- Policlinico Univ. Agostino Gemelli
- Instituto Jalisciense de Investigacion en Diabetes y Obesida
- Unidad de patologia Clinica
- Centro de Inv. Medica de Occidente, SC
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
- Centro de Endocrinologia y Nutricion del Turabo
- Paola Mansilla-Letelier, MD
- SC Endodigest SRL
- S. C. Grandmed S.R.L.
- C.M.D.T.A. Neomed
- SC Gama Diamed SRL
- CMI DNBM Dr. Pop Lavinia
- SC Cosamext SRL
- SC Diabmed Dr Popescu Alexandrina SRL
- SC Dianutrilife Medica SRL
- Centrul Medical Dr. Negrisanu
- Cabinetul Medical Nicodiab SRL
- SC Nutrilife SRL
- Milena Sante SRL
- Arkhangelsk Regional Clinical Hospital
- Scientific and Clinical Center for Precision and Regenerative Medicine
- Pirogov Russian National Research Medical University
- First Moscow State Medical University
- SPb GUZ "Diagnostic Center #85"
- City Consultative and Diagnostic Center #1
- Saint-Petersburg State Budgetary Institution of Healthcare Institution
- St.Petersburg Polyclinic #117
- Diacrin s.r.o.
- MediVet s.r.o.
- Human care s.r.o.
- Diabetes care s.r.o.
- Areteus s.r.o.
- Hospital Quiron Infanta Luisa
- Hospital Universitario Marqués de Valdecilla
- Complejo Hospitalario Universitario De Ferrol - Hospital Naval
- Clínica Juaneda
- Hospital Universitario Virgen Macarena
- Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi
- Akdeniz University Medical Faculty
- Aydin Adnan Menderes Universitesi
- Gaziantep University Medical Faculty
- Inonu Universitesi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
5 mg Tirzepatide
10 mg Tirzepatide
15 mg Tirzepatide
Insulin Lispro (U100)
Arm Description
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week with insulin glargine (U100) administered SC.
10 mg tirzepatide administered SC once a week with insulin glargine (U100) administered SC.
15 mg tirzepatide administered SC once a week with insulin glargine (U100) administered SC.
Insulin lispro (U100) administered SC three times a day with insulin glargine (U100) administered SC.
Outcomes
Primary Outcome Measures
Change from Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses)
Change from Baseline in HbA1c
Secondary Outcome Measures
Change from Baseline in HbA1c (Individual Doses)
Change from Baseline in HbA1c
Percentage of Participants with HbA1c Target Values <7.0%
Percentage of Participants with HbA1c Target Values <7.0%
Change from Baseline in Body Weight
Change from Baseline in Body Weight
Change from Baseline in Fasting Serum Glucose
Change from Baseline in Fasting Serum Glucose
Mean Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Mean Change from Baseline in Daily Average 7-Point SMBG Values
Percentage of Participants who Achieved HbA1c Target Value of <7.0% without Hypoglycemia
Percentage of Participants who Achieved HbA1c Target Value of <7.0% without Hypoglycemia
Percentage of Participants who Achieved Weight Loss ≥5%
Percentage of Participants who Achieved Weight Loss ≥5%
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
Change from Baseline in SF-36 PCS Score
Change from Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score
Change from Baseline in SF-36 MCS Score
Full Information
NCT ID
NCT04537923
First Posted
September 2, 2020
Last Updated
November 22, 2022
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT04537923
Brief Title
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
Acronym
SURPASS-6
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
2. Study Status
Record Verification Date
November 15, 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
October 11, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist, T2DM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1428 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5 mg Tirzepatide
Arm Type
Experimental
Arm Description
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week with insulin glargine (U100) administered SC.
Arm Title
10 mg Tirzepatide
Arm Type
Experimental
Arm Description
10 mg tirzepatide administered SC once a week with insulin glargine (U100) administered SC.
Arm Title
15 mg Tirzepatide
Arm Type
Experimental
Arm Description
15 mg tirzepatide administered SC once a week with insulin glargine (U100) administered SC.
Arm Title
Insulin Lispro (U100)
Arm Type
Active Comparator
Arm Description
Insulin lispro (U100) administered SC three times a day with insulin glargine (U100) administered SC.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro (U100)
Other Intervention Name(s)
LY275585
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine (U100)
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change from Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses)
Description
Change from Baseline in HbA1c
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Change from Baseline in HbA1c (Individual Doses)
Description
Change from Baseline in HbA1c
Time Frame
Baseline, Week 52
Title
Percentage of Participants with HbA1c Target Values <7.0%
Description
Percentage of Participants with HbA1c Target Values <7.0%
Time Frame
Week 52
Title
Change from Baseline in Body Weight
Description
Change from Baseline in Body Weight
Time Frame
Baseline, Week 52
Title
Change from Baseline in Fasting Serum Glucose
Description
Change from Baseline in Fasting Serum Glucose
Time Frame
Baseline, Week 52
Title
Mean Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Description
Mean Change from Baseline in Daily Average 7-Point SMBG Values
Time Frame
Baseline, Week 52
Title
Percentage of Participants who Achieved HbA1c Target Value of <7.0% without Hypoglycemia
Description
Percentage of Participants who Achieved HbA1c Target Value of <7.0% without Hypoglycemia
Time Frame
Week 52
Title
Percentage of Participants who Achieved Weight Loss ≥5%
Description
Percentage of Participants who Achieved Weight Loss ≥5%
Time Frame
Week 52
Title
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
Description
Change from Baseline in SF-36 PCS Score
Time Frame
Baseline, Week 52
Title
Change from Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score
Description
Change from Baseline in SF-36 MCS Score
Time Frame
Baseline, Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Syed Research Consultants Llc
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute - Huntington Park
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
National Research Institute - Huntington Park
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
National Research Institute (NRI) - Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Excel Medical Clinical Trials
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
I R & Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Sun Coast Clinical Research, Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
South Broward Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
J H. Stroger Hosp of Cook Co
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62711
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Capital Diabetes and Endocrine Associates
City
Camp Springs
State/Province
Maryland
ZIP/Postal Code
20746
Country
United States
Facility Name
MedStar Health Research Institute
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Endocrine and Metabolic Consultants
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Glacier View Research Institute - Endocrinology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Southern Nh Diabetes and Endocrinology
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Intend Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Heritage Valley Medical Group, Inc.
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Diabetes and Thyroid Center of Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Juno Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
North Hills Medical Research
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Consano Clinical Research, LLC
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Martin Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Centro Médico Viamonte
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Investigaciones Medicas Imoba Srl
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1179AAB
Country
Argentina
Facility Name
Instituto Centenario
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1204AAD
Country
Argentina
Facility Name
Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta
City
Rosario
State/Province
Buenos Aires
ZIP/Postal Code
S2000BIF
Country
Argentina
Facility Name
CIPADI
City
Godoy Cruz
State/Province
Mendoza
ZIP/Postal Code
M5501ARP
Country
Argentina
Facility Name
Instituto Médico Catamarca
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Instituto Médico Especializado (IME)
City
Buenos Aires
ZIP/Postal Code
1405
Country
Argentina
Facility Name
Asociación de Beneficencia Hospital Sirio Libanés
City
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Facility Name
CENUDIAB
City
Ciudad Autónoma de Buenos Aire
ZIP/Postal Code
C1440AAD
Country
Argentina
Facility Name
Centro Diabetologico Dr Waitman
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Centro Medico Privado San Vicente Diabetes
City
Cordoba
ZIP/Postal Code
X5006CBI
Country
Argentina
Facility Name
Sanatorio Parque
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
AZ Damiaan Oostende
City
Oostende
ZIP/Postal Code
8400
Country
Belgium
Facility Name
Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-350
Country
Brazil
Facility Name
CEDOES
City
Vitoria
State/Province
ES
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
Cline Research Center
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80030
Country
Brazil
Facility Name
QUANTA - Medicina Nuclear Alto da XV
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80045-170
Country
Brazil
Facility Name
Centro de Pesquisas em Diabetes
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
CPCLIN
City
São Paulo
State/Province
SP
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
Hospital PUC-CAMPINAS
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
CECIP - Centro de Estudos do Interior Paulista
City
Jaú
State/Province
São Paulo
ZIP/Postal Code
17201-130
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda
City
São Bernardo do Campo
State/Province
São Paulo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12243-280
Country
Brazil
Facility Name
Instituto Brasil de Pesquisa Clínica - IBPCLIN
City
Rio de Janeiro
ZIP/Postal Code
20241180
Country
Brazil
Facility Name
IPEC - Instituto de Pesquisa Clínica
City
São Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Facility Name
CPQuali Pesquisa Clínica
City
São Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
BR Trials - Ensaios Clínicos e Consultoria Ltda
City
São Paulo
ZIP/Postal Code
03325-050
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigação Clínica
City
São Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Diabetologicka ordinace pro dospele
City
Krnov
State/Province
Moravskoslezský Kraj
ZIP/Postal Code
79401
Country
Czechia
Facility Name
Diabetologicka a obezitologicka ambulance
City
Ceske Budejovice
ZIP/Postal Code
370 11
Country
Czechia
Facility Name
Diahelp s.r.o., Interni a diabetologicka ambulance
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
ResTrial s.r.o.
City
Praha 8
ZIP/Postal Code
181 00
Country
Czechia
Facility Name
Schwerpunktpraxis für Diabetes
City
Hof
State/Province
Bavaria
ZIP/Postal Code
95030
Country
Germany
Facility Name
InnoDiab Forschung Gmbh
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Medizentrum Essen-Borbeck
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Zentrum für klinische Studien
City
Saint Ingbert
State/Province
Saarland
ZIP/Postal Code
66386
Country
Germany
Facility Name
RED-Institut GmbH
City
Oldenburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
MVZ im Altstadt-Carree Fulda GmbH
City
Fulda
ZIP/Postal Code
36037
Country
Germany
Facility Name
Diabetologische Schwerpunktpraxis Harburg
City
Hamburg
ZIP/Postal Code
21073
Country
Germany
Facility Name
Diabeteszentrum Hamburg West
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
City
Wallerfing
ZIP/Postal Code
94574
Country
Germany
Facility Name
Iatriko Palaiou Falirou, Medical Center
City
Palaio Faliro
State/Province
Athens
ZIP/Postal Code
17562
Country
Greece
Facility Name
Athens Euroclinic
City
Athens
State/Province
Attiki
ZIP/Postal Code
11521
Country
Greece
Facility Name
General Hospital of Thessaloniki Papageorgiou
City
N. Efkarpia
State/Province
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
Thermi Clinic
City
Thermi
State/Province
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Belinus Bt
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Szent Margit Rendelőintézet Nonprofit Kft
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
TRANTOR'99 Bt. Anyagcsere Centrum
City
Budapest
ZIP/Postal Code
1213
Country
Hungary
Facility Name
Policlinico Mater Domini
City
Germaneto
State/Province
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Casa di Cura Multimedica-Policlinico Multispecialistico
City
Sesto San Giovanni
State/Province
MI
ZIP/Postal Code
20099
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Policlinico Univ. Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Instituto Jalisciense de Investigacion en Diabetes y Obesida
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Unidad de patologia Clinica
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Centro de Inv. Medica de Occidente, SC
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45116
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
N.l.
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
City
Madero
State/Province
Tamaulipas
ZIP/Postal Code
89440
Country
Mexico
Facility Name
Centro de Endocrinologia y Nutricion del Turabo
City
Caguas
ZIP/Postal Code
00726
Country
Puerto Rico
Facility Name
Paola Mansilla-Letelier, MD
City
Guaynabo
ZIP/Postal Code
00970
Country
Puerto Rico
Facility Name
SC Endodigest SRL
City
Oradea
State/Province
Bihor
ZIP/Postal Code
410151
Country
Romania
Facility Name
S. C. Grandmed S.R.L.
City
Oradea
State/Province
Bihor
ZIP/Postal Code
410159
Country
Romania
Facility Name
C.M.D.T.A. Neomed
City
Brasov
State/Province
Brașov
ZIP/Postal Code
500283
Country
Romania
Facility Name
SC Gama Diamed SRL
City
Mangalia
State/Province
Constanta
ZIP/Postal Code
905500
Country
Romania
Facility Name
CMI DNBM Dr. Pop Lavinia
City
Baia Mare
State/Province
Maramures
ZIP/Postal Code
430222
Country
Romania
Facility Name
SC Cosamext SRL
City
Targu Mures
State/Province
Mures
ZIP/Postal Code
540098
Country
Romania
Facility Name
SC Diabmed Dr Popescu Alexandrina SRL
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100179
Country
Romania
Facility Name
SC Dianutrilife Medica SRL
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100561
Country
Romania
Facility Name
Centrul Medical Dr. Negrisanu
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300456
Country
Romania
Facility Name
Cabinetul Medical Nicodiab SRL
City
Bucharest
ZIP/Postal Code
010507
Country
Romania
Facility Name
SC Nutrilife SRL
City
Bucuresti
ZIP/Postal Code
013671
Country
Romania
Facility Name
Milena Sante SRL
City
Galati
ZIP/Postal Code
800001
Country
Romania
Facility Name
Arkhangelsk Regional Clinical Hospital
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Scientific and Clinical Center for Precision and Regenerative Medicine
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Pirogov Russian National Research Medical University
City
Moscow
ZIP/Postal Code
109263
Country
Russian Federation
Facility Name
First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
SPb GUZ "Diagnostic Center #85"
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
City Consultative and Diagnostic Center #1
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Institution of Healthcare Institution
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
St.Petersburg Polyclinic #117
City
Saint-Petersburg
ZIP/Postal Code
194358
Country
Russian Federation
Facility Name
Diacrin s.r.o.
City
Bratislava
State/Province
Bratislavský Kraj
ZIP/Postal Code
841 02
Country
Slovakia
Facility Name
MediVet s.r.o.
City
Malacky
State/Province
Bratislavský Kraj
ZIP/Postal Code
901 01
Country
Slovakia
Facility Name
Human care s.r.o.
City
Kosice
State/Province
Slovak Republic
ZIP/Postal Code
04012
Country
Slovakia
Facility Name
Diabetes care s.r.o.
City
Hnusta
ZIP/Postal Code
98101
Country
Slovakia
Facility Name
Areteus s.r.o.
City
Trebisov
ZIP/Postal Code
075 01
Country
Slovakia
Facility Name
Hospital Quiron Infanta Luisa
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41010
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39011
Country
Spain
Facility Name
Complejo Hospitalario Universitario De Ferrol - Hospital Naval
City
Ferrol
State/Province
La Coruna
ZIP/Postal Code
15405
Country
Spain
Facility Name
Clínica Juaneda
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi
City
Adana
ZIP/Postal Code
01240
Country
Turkey
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Aydin Adnan Menderes Universitesi
City
Aydin
ZIP/Postal Code
09010
Country
Turkey
Facility Name
Gaziantep University Medical Faculty
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Inonu Universitesi
City
Malatya
ZIP/Postal Code
44282
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/11LK1nZPXq4bEVBd2Mdi2i
Description
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 (SURPASS-6)
Learn more about this trial
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
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