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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Tirzepatide; Drug: Insulin Lispro (U100)

• Study Type: Interventional
• Enrollment (Actual): 1428
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1405
    • Instituto Médico Especializado (IME)
  • Buenos Aires, Argentina, C1419AHN
    • Asociación de Beneficencia Hospital Sirio Libanés
  • Ciudad Autónoma de Buenos Aire, Argentina, C1440AAD
    • CENUDIAB
  • Cordoba, Argentina, 5000
    • Centro Diabetologico Dr Waitman
  • Cordoba, Argentina, X5006CBI
    • Centro Médico Privado San Vicente Diabetes
  • Salta, Argentina, 4400
    • Sanatorio Parque
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1120AAC
      • Centro Médico Viamonte
    • Caba, Buenos Aires, Argentina, C1179AAB
      • Investigaciones Medicas Imoba Srl
    • Caba, Buenos Aires, Argentina, C1204AAD
      • Instituto Centenario
    • Rosario, Buenos Aires, Argentina, S2000BIF
      • Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta
  • Mendoza
    • Godoy Cruz, Mendoza, Argentina, M5501ARP
      • CIPADI
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto Medico Catamarca
• Belgium
  • Oostende, Belgium, 8400
    • AZ Damiaan Oostende
• Brazil
  • Rio de Janeiro, Brazil, 20241180
    • Instituto Brasil de Pesquisa Clínica - IBPCLIN
  • São Paulo, Brazil, 01228-000
    • CPQuali Pesquisa Clínica
  • São Paulo, Brazil, 04266-010
    • CEPIC - Centro Paulista de Investigacao Clinica
  • São Paulo, Brazil, 01223-001
    • IPEC - Instituto de Pesquisa Clínica
  • São Paulo, Brazil, 03325-050
    • BR Trials - Ensaios Clínicos e Consultoria Ltda
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-350
      • Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.
  • ES
    • Vitoria, ES, Brazil, 29055-450
      • CEDOES
  • Paraná
    • Curitiba, Paraná, Brazil, 80045-170
      • QUANTA - Medicina Nuclear Alto da XV
    • Curitiba, Paraná, Brazil, 80030
      • Cline Research Center
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
      • Centro de Pesquisas em Diabetes
  • SP
    • São Paulo, SP, Brazil, 01228-200
      • CPCLIN
  • São Paulo
    • Campinas, São Paulo, Brazil, 13060-904
      • Hospital PUC-CAMPINAS
    • Jaú, São Paulo, Brazil, 17201-130
      • CECIP - Centro de Estudos do Interior Paulista
    • São Bernardo do Campo, São Paulo, Brazil, 09715-090
      • CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda
    • São José dos Campos, São Paulo, Brazil, 12243-280
      • ISPEM - Instituto São José dos Campos em Pesquisas Médicas
• Czechia
  • Ceske Budejovice, Czechia, 370 11
    • Diabetologicka a obezitologicka ambulance
  • Pardubice, Czechia, 530 02
    • Diahelp s.r.o., Interni a diabetologicka ambulance
  • Praha 8, Czechia, 181 00
    • ResTrial s.r.o.
  • Moravskoslezský Kraj
    • Krnov, Moravskoslezský Kraj, Czechia, 79401
      • Diabetologicka ordinace pro dospele
• Germany
  • Fulda, Germany, 36037
    • MVZ im Altstadt-Carree Fulda GmbH
  • Hamburg, Germany, 22607
    • Diabeteszentrum Hamburg West
  • Hamburg, Germany, 21073
    • Diabetologische Schwerpunktpraxis Harburg
  • Wallerfing, Germany, 94574
    • Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
  • Bavaria
    • Hof, Bavaria, Germany, 95030
      • Schwerpunktpraxis für Diabetes
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • InnoDiab Forschung GmbH
    • Essen, Nordrhein-Westfalen, Germany, 45355
      • Medizentrum Essen-Borbeck
  • Saarland
    • Saint Ingbert, Saarland, Germany, 66386
      • Zentrum für klinische Studien
  • Schleswig-Holstein
    • Oldenburg, Schleswig-Holstein, Germany, 23758
      • RED-Institut GmbH
• Greece
  • Athens
    • Palaio Faliro, Athens, Greece, 17562
      • Iatriko Palaiou Falirou, Medical Center
  • Attiki
    • Athens, Attiki, Greece, 11521
      • Athens Euroclinic
  • Thessaloniki
    • N. Efkarpia, Thessaloniki, Greece, 56403
      • General Hospital of Thessaloniki Papageorgiou
    • Thermi, Thessaloniki, Greece, 57001
      • Thermi Clinic
• Hungary
  • Budapest, Hungary, 1032
    • Szent Margit Rendelőintézet Nonprofit Kft
  • Budapest, Hungary, 1213
    • TRANTOR'99 Bt. Anyagcsere Centrum
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet
    • Debrecen, Hajdu-Bihar, Hungary, 4025
      • Belinus Bt
• Italy
  • Milano, Italy, 20157
    • Ospedale Luigi Sacco
  • Roma, Italy, 00168
    • Policlinico Univ. Agostino Gemelli
  • Catanzaro
    • Germaneto, Catanzaro, Italy, 88100
      • Policlinico Mater Domini
  • MI
    • Sesto San Giovanni, MI, Italy, 20099
      • Casa di Cura Multimedica-Policlinico Multispecialistico
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • Instituto Jalisciense de Investigacion en Diabetes y Obesida
    • Guadalajara, Jalisco, Mexico, 44650
      • Unidad de patologia Clinica
    • Zapopan, Jalisco, Mexico, 45116
      • Centro de Inv. Medica de Occidente, SC
  • N.l.
    • Monterrey, N.l., Mexico, 64460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Tamaulipas
    • Madero, Tamaulipas, Mexico, 89440
      • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
• Puerto Rico
  • Caguas, Puerto Rico, 00726
    • Centro de Endocrinologia y Nutricion del Turabo
  • Guaynabo, Puerto Rico, 00970
    • Paola Mansilla-Letelier, MD
• Romania
  • Bucharest, Romania, 010507
    • Cabinetul Medical Nicodiab SRL
  • Bucuresti, Romania, 013671
    • SC Nutrilife SRL
  • Galati, Romania, 800001
    • Milena Sante SRL
  • Bihor
    • Oradea, Bihor, Romania, 410151
      • SC Endodigest SRL
    • Oradea, Bihor, Romania, 410159
      • S. C. Grandmed S.R.L.
  • Brașov
    • Brasov, Brașov, Romania, 500283
      • C.M.D.T.A. Neomed
  • Constanta
    • Mangalia, Constanta, Romania, 905500
      • SC Gama Diamed SRL
  • Maramures
    • Baia Mare, Maramures, Romania, 430222
      • CMI DNBM Dr. Pop Lavinia
  • Mures
    • Targu Mures, Mures, Romania, 540098
      • SC Cosamext SRL
  • Prahova
    • Ploiesti, Prahova, Romania, 100179
      • SC Diabmed Dr Popescu Alexandrina SRL
    • Ploiesti, Prahova, Romania, 100561
      • SC Dianutrilife Medica SRL
  • Timis
    • Timisoara, Timis, Romania, 300456
      • Centrul Medical Dr. Negrisanu
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk Regional Clinical Hospital
  • Kazan, Russian Federation, 420012
    • Scientific and Clinical Center for Precision and Regenerative Medicine
  • Moscow, Russian Federation, 119435
    • First Moscow State Medical University
  • Moscow, Russian Federation, 109263
    • Pirogov Russian National Research Medical University
  • Saint Petersburg, Russian Federation, 198255
    • SPb GUZ "Diagnostic Center #85"
  • Saint-Petersburg, Russian Federation, 194354
    • City Consultative and Diagnostic Center #1
  • Saint-Petersburg, Russian Federation, 194354
    • Saint-Petersburg State Budgetary Institution of Healthcare Institution
  • Saint-Petersburg, Russian Federation, 194358
    • St.Petersburg Polyclinic #117
• Slovakia
  • Hnusta, Slovakia, 98101
    • Diabetes care s.r.o.
  • Trebisov, Slovakia, 075 01
    • Areteus s.r.o.
  • Bratislavský Kraj
    • Bratislava, Bratislavský Kraj, Slovakia, 841 02
      • Diacrin s.r.o.
    • Malacky, Bratislavský Kraj, Slovakia, 901 01
      • MediVet s.r.o.
  • Slovak Republic
    • Kosice, Slovak Republic, Slovakia, 04012
      • Human Care s.r.o.
• Spain
  • Palma de Mallorca, Spain, 07014
    • Clínica Juaneda
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Andalucía
    • Sevilla, Andalucía, Spain, 41010
      • Hospital Quiron Infanta Luisa
  • Cantabria
    • Santander, Cantabria, Spain, 39011
      • Hospital Universitario Marqués de Valdecilla
  • La Coruna
    • Ferrol, La Coruna, Spain, 15405
      • Complejo Hospitalario Universitario De Ferrol - Hospital Naval
• Turkey
  • Adana, Turkey, 01240
    • Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi
  • Antalya, Turkey, 07059
    • Akdeniz University Medical Faculty
  • Aydin, Turkey, 09010
    • Aydin Adnan Menderes Universitesi
  • Gaziantep, Turkey, 27310
    • Gaziantep University Medical Faculty
  • Malatya, Turkey, 44282
    • Inonu universitesi
• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Syed Research Consultants Llc
  • California
    • Fresno, California, United States, 93720
      • Valley Research
    • Huntington Park, California, United States, 90255
      • National Research Institute - Huntington Park
    • Los Angeles, California, United States, 90057
      • National Research Institute - Huntington Park
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Panorama City, California, United States, 91402
      • National Research Institute - Huntington Park
    • Santa Ana, California, United States, 92704
      • National Research Institute (NRI) - Santa Ana
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Tustin, California, United States, 92780
      • University Clinical Investigators, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Excel Medical Clinical Trials
    • Hialeah, Florida, United States, 33012
      • I R & Health Center, Inc.
    • New Port Richey, Florida, United States, 34652
      • Sun Coast Clinical Research, Inc
    • Pembroke Pines, Florida, United States, 33027
      • South Broward Research
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute, Inc.
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60612
      • J H. Stroger Hosp of Cook Co
    • Springfield, Illinois, United States, 62711
      • Prairie Education and Research Cooperative
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Research Center
  • Maryland
    • Camp Springs, Maryland, United States, 20746
      • Capital Diabetes and Endocrine Associates
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Institute
    • Rockville, Maryland, United States, 20852
      • Endocrine and Metabolic Consultants
  • Montana
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute - Endocrinology
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Southern NH Diabetes and Endocrinology
  • New York
    • Albany, New York, United States, 12203
      • Albany Medical College
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Medical Group, Inc.
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research, LLC
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Fort Worth, Texas, United States, 76132
      • Diabetes and Thyroid Center of Fort Worth
    • Houston, Texas, United States, 77040
      • Juno Research
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, Llc
    • North Richland Hills, Texas, United States, 76180
      • North Hills Medical Research
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes & Endocrinology, P.A.
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 mg Tirzepatide; 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Experimental: 10 mg Tirzepatide; 10 mg tirzepatide administered SC once a week.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Experimental: 15 mg Tirzepatide; 15 mg tirzepatide administered SC once a week.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Active Comparator: Insulin Lispro; Insulin lispro 100 units per milliliter (U100) administered SC three times a day.	Drug: Insulin Lispro (U100); Administered SC; Other Names: LY275585

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Percentage of Participants Who Achieved Weight Loss ≥5%	Percentage of Participants who Achieved Weight Loss ≥5% is reported here.	Week 52
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
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

• 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)

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): October 11, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: T2DM; glucagon-like peptide-1 (GLP-1); GIP/GLP-1 dual receptor agonist; glucose-dependent insulinotropic polypeptide (GIP)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Insulin Lispro; Tirzepatide
• Other Study ID Numbers: 17204; I8F-MC-GPHD (Other Identifier: Eli Lilly and Company); 2020-000284-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No