A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
AWARD-11
A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus
3 other identifiers
interventional
1,842
16 countries
208
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Apr 2018
208 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2018
CompletedStudy Start
First participant enrolled
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2019
CompletedResults Posted
Study results publicly available
June 12, 2020
CompletedJune 12, 2020
December 15, 2019
1.1 years
April 2, 2018
May 28, 2020
May 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin A1c (HbA1c) From Baseline
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Baseline, Week 36
Secondary Outcomes (6)
Change in Body Weight From Baseline
Baseline, Week 36
Percentage of Participants Achieving HbA1c Target <7.0%
Week 36
Change in Fasting Serum Glucose (FSG) From Baseline
Baseline, Week 36
Rate of Documented Symptomatic Hypoglycemic Episodes
Week 36
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)
Week 4, Week 12, Week 36, Week 52
- +1 more secondary outcomes
Study Arms (3)
Dulaglutide 1.5 mg
ACTIVE COMPARATORDulaglutide 1.5 mg administered subcutaneously (SC) once a week.
Dulaglutide 3 mg
EXPERIMENTALDulaglutide 3 mg administered SC once a week.
Dulaglutide 4.5 mg
EXPERIMENTALDulaglutide 4.5 mg administered SC once a week.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Have type 2 diabetes mellitus (T2DM) for at least 6 months
- Have been treated with stable metformin dose for at least 3 months
- Have HbA1c ≥7.5% and ≤11.0% at study entry
- Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m\^2)
You may not qualify if:
- Have type 1 diabetes mellitus
- Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days)
- Have been taking any other medicine for diabetes (other than metformin) during the last 3 months
- Have used in the last 3 months (or plan to use) prescription weight loss medications
- Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss
- Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes)
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
- Had chronic or acute pancreatitis any time prior to study entry
- Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity
- Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73m\^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in
- Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
- Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (208)
Synexus- Chandler
Chandler, Arizona, 85224, United States
Synexus/Central Arizona Medical Associates, PC
Mesa, Arizona, 85206, United States
Central Phoenix Med Clinic LLC
Phoenix, Arizona, 85020, United States
Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Valley Research
Fresno, California, 93720, United States
National Research Institute
Huntington Park, California, 90255, United States
National Research Institute
Los Angeles, California, 90057, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Pacific Research Partners, LLC
Oakland, California, 94607, United States
National Research Institute
Panorama City, California, 91402, United States
Sierra Clinical Research
Roseville, California, 95661, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Care Access Research
Santa Clarita, California, 91321, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
ALL Medical Research, LLC
Cooper City, Florida, 33024, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33175, United States
Oviedo Medical Research
Oviedo, Florida, 32765, United States
Urban Family Practice Associates, PC
Marietta, Georgia, 30067, United States
In-Quest Medical Research, LLC- Peachtree Corners
Peachtree Corners, Georgia, 30071, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96813, United States
East West Medical Institute
Honolulu, Hawaii, 96814, United States
Elite Clinical Trials LLLP
Blackfoot, Idaho, 83221, United States
Saltzer Medical Group. P.A.
Nampa, Idaho, 83686, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62711, United States
Synexus/Clinical Research Advantage
Evansville, Indiana, 47714, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260, United States
Iderc, P.L.C.
West Des Moines, Iowa, 50265, United States
InterMed, PA
Portland, Maine, 04101, United States
MedStar Health Research Institute
Hyattsville, Maryland, 20782, United States
NECCR PrimaCare Research, LLC
Fall River, Massachusetts, 02721, United States
Aa Mrc Llc
Flint, Michigan, 48504, United States
Troy Internal Medicine, PC
Troy, Michigan, 48098, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, 63303, United States
Montana Health Research
Billings, Montana, 59102, United States
Glacier View Research Institute
Kalispell, Montana, 59901, United States
Premier Research
Trenton, New Jersey, 08611, United States
Manhattan Medical Research
New York, New York, 10016, United States
Great Lakes Medical Research
Westfield, New York, 14787, United States
Metrolina Internal Medicine, P.A.
Charlotte, North Carolina, 28207, United States
Diabetes & Endocrinology Consultants PC
Morehead City, North Carolina, 28557, United States
Aventiv Research
Columbus, Ohio, 43213, United States
Intend Research
Norman, Oklahoma, 73069, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330, United States
Summit Research Network Inc
Portland, Oregon, 97210, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009, United States
Detweiler Family Medicine
Lansdale, Pennsylvania, 19446, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15236, United States
Sudir Bansal M.D. Inc.
Warwick, Rhode Island, 02886, United States
PMG Research of Charleston, LLC
Moncks Corner, South Carolina, 29461, United States
Chattanooga Research and Medicine (CHARM)
Chattanooga, Tennessee, 37404, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230, United States
Southern Endocrinology and Associates PA
Mesquite, Texas, 75149, United States
Consano Clinical Research
Shavano Park, Texas, 78231, United States
Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
ClinPoint Trials, LLC
Waxahachie, Texas, 75165, United States
Progressive Clinical Research
Bountiful, Utah, 84010, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23235, United States
Capital Clincial Research Center
Olympia, Washington, 98502, United States
Walla Walla Clinic
Walla Walla, Washington, 99362, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, 98801, United States
Prevea Clinic, Inc
Green Bay, Wisconsin, 54303, United States
Centro Medico CICEMO
Caba, Buenos Aires, 1405, Argentina
CEDIC-Centro de Investigaciones Clinicas
Caba, Buenos Aires, 1425, Argentina
Investigaciones Medicas IMOBA S.R.L.
Caba, Buenos Aires, C1179AAB, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ, Argentina
Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425AGC, Argentina
Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
Ciudad Autonoma de, Buenos Aires, C1119ACN, Argentina
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, Buenos Aires, B7600FZN, Argentina
CIPADI
Godoy Cruz, Mendoza Province, M5501ARP, Argentina
AXISMED SRL - Bioclinica Research Network
Buenos Aires, C1430CKE, Argentina
CENUDIAB
Ciudad Autonoma de Buenos Aire, 1408, Argentina
Centro Médico Viamonte
Ciudad Autonoma de Buenos Aire, C1120AAC, Argentina
Instituto Centenario
Ciudad Autonoma de Buenos Aire, C1204AAD, Argentina
Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff
Ciudad Autonoma de Buenos Aire, C1205AAO, Argentina
Mautalen Salud e Investigación - Servicio de Endocrinología
Ciudad Autonoma de Buenos Air, C1128AAF, Argentina
Instituto Medico Strusberg
Córdoba, X5000EDC, Argentina
Centro Medico Privado San Vicente Diabetes
Córdoba, X5006CBI, Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, X5008HHW, Argentina
Landesklinikum Korneuburg-Stockerau, Standort Stockerau
Stockerau, Lower Austria, 2000, Austria
Universitätsklinikum Graz
Graz, Styria, 8036, Austria
Ordination Dr. Evelyn Fließer-Görzer
Saint Stefan Ob Stainz, Styria, 8511, Austria
VIVIT Institut am LKH Feldkirch
Feldkirch, Vorarlberg, 6800, Austria
KA Rudolfstiftung
Vienna, 1030, Austria
Zentrum für klinische Studien Dr. Ursula Hanusch GmbH
Vienna, 1060, Austria
Bailey Clinic
Red Deer, Alberta, T4N 6V7, Canada
Aggarwal and Associates Ltd
Brampton, Ontario, L6T 0G1, Canada
T. Nemtean Medicine Professional Corporation
Mississauga, Ontario, L4Y 2N8, Canada
Bluewater Clinical Research Group Inc
Sarnia, Ontario, N7T 4X3, Canada
Stayner Medical Clinic
Stayner, Ontario, L0M 1S0, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4, Canada
Iatriko Palaiou Falirou, Medical Center
Palaió Fáliro, Athens, 17562, Greece
Laiko General Hospital of Athens
Ampelokipoi, Attica, 11527, Greece
Gen Hospital of Athens G Gennimatas
Athens, Attica, 11527, Greece
G.Papanikolaou General Hospital
Eksochi, Thessaloniki, 57010, Greece
Thermi Clinic
Thermi, Thessaloniki, 57001, Greece
Athens Euroclinic
Athens, 11521, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
AHEPA Hospital
Thessaloniki, 54636, Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, 54639, Greece
Euromedica - General Clinic of Thessaloniki
Thessaloniki, 54645, Greece
Studium Egeszseghaz Kft.
Kalocsa, Bács-Kiskun county, 6300, Hungary
Kenezy Gyula Korhaz es Rendelointezet
Debrecen, Hajdú-Bihar, 4031, Hungary
Grof Esterhazy Korhaz es Rendelointezeti Szakrendelo
Pápa, Veszprém megye, 8500, Hungary
Szent Margit Rendelointezet
Budapest, 1032, Hungary
ClinDiab Kft.
Budapest, 1089, Hungary
Strazsahegy Medicina Bt.
Budapest, 1171, Hungary
TRANTOR 99 Bt.
Budapest, 1213, Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa, 8800, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, 8900, Hungary
Maccabi Diabetes Clinic, Grand Canyon, North District, Haifa
Haifa, 3299001, Israel
Linn Medical Center
Haifa, 3515209, Israel
Hadassah Medical Center
Jerusalem, 911201, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Clalit Health Services - Shuali Clinic
Raanana, 4345204, Israel
ZIV Medical Center
Safed, 13100, Israel
Sakhnin Community Clinic, Clalit Health Services
Sakhnin, 3081000, Israel
Diabetes Medical Center (DMC)
Tel Aviv, 6148002, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Azienda Ospedaliera Universitaria Careggi
Florence, Florence, 50134, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, SI, 53100, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Policlinico Mater Domini
Catanzaro, 88100, Italy
Fondazione Universitaria degli Studi G D'Annunzio
Chieti, 66100, Italy
Ospedale Santa Maria Goretti
Latina, 04100, Italy
Policlinico Giaccone
Palermo, 90127, Italy
Ospedale Civile Maggiore Borgo Trento
Verona, 37126, Italy
Hospital Univ. Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Investigacion en Salud y Metabolismo S.C
Chihuahua City, 31217, Mexico
NZOZ ZDROWIE Osteo-Medic
Bialystok, 15-351, Poland
Poradnia Diabetologiczna SN ZOZ Lege Artis
Bialystok, 15-404, Poland
NS ZOZ Osrodek Diabetologiczny " Popula"
Bialystok, 15-445, Poland
Centrum Badan Klinicznych, PI House
Gdansk, 80-546, Poland
NZOZ Salvia s.c.
Katowice, 40-772, Poland
NZOZ Diab-Endo-Met
Krakow, 31-261, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, 90-242, Poland
Gabinety Terpa
Lublin, 20-333, Poland
NZOZ Przychodnia Specjalistyczna MEDICA
Lublin, 20-538, Poland
Centrum Medyczne OMEDICA
Poznan, 60-111, Poland
Praktyka Lekarska
Poznan, 61-655, Poland
Nzoz Neuro - Kard
Poznan, 61-853, Poland
NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek
Ruda Śląska, 41-709, Poland
Centralny Szpital Kliniczny MSW
Warsaw, 02-507, Poland
Regionalna Poradnia Diabetologiczna
Wroclaw, 50-127, Poland
Research and Cardiovascular Corp.
Ponce, PR, 00717, Puerto Rico
Office: Dr. Luis Rivera Colon
San Juan, PR, 00921, Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, 00909, Puerto Rico
GCM Medical Group PSC
San Juan, 00917, Puerto Rico
S. C. Grandmed S.R.L., Str.
Oradea, Bihor County, 410159, Romania
SC Gama Diamed SRL
Mangalia, Constanța County, 905500, Romania
Spitalul Judetean de Urgenta Satu Mare
Satu Mare, Jud Satu-Mare, 440055, Romania
CMI DNBM Dr. Pop Lavinia
Baia Mare, Maramureş, 430222, Romania
Cosamext SRL
Târgu Mureş, Mureș County, 540098, Romania
SC Diabmed Dr Popescu Alexandrina SRL
Ploieşti, Prahova, 100163, Romania
SC Dianutrilife Medica SRL
Ploieşti, Prahova, 100561, Romania
Centrul Medical Dr. Negrisanu
Timișoara, Timiș County, 300456, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov, 500283, Romania
Cabinetul Medical Nicodiab SRL
Bucharest, 010507, Romania
Easydiet SRL
Bucharest, 010627, Romania
SC Nutrilife SRL
Bucharest, 013682, Romania
SC Medcon SRL
Buzău, 120203, Romania
Centrul Medical Unirea SRL
Cluj-Napoca, 400349, Romania
Cabinet Medical Urodiamed S.R.L.
Craiova, 200349, Romania
Milena Sante SRL
Galati, 800001, Romania
SC Olimpia Med SRL
Iași, 700400, Romania
Regional Clinical Hospital
Saratov, Russian Federation, 410053, Russia
Arkhangelsk Regional Clinical Hospital
Arkhangelsk, 163045, Russia
Arkhangelsk the first city clinical hospital
Arkhangelsk, 163045, Russia
Rostov State Medical University
Rostov-on-Don, 344022, Russia
City Hospital of Saint Martyr Elizabeth
Saint Petersburg, 193257, Russia
SPb GUZ "Diagnostic Center #85"
Saint Petersburg, 198255, Russia
Human care s.r.o.
Košice, Slovak Republic, 04012, Slovakia
MediVet s.r.o.
Malacky, Slovak Republic, 90101, Slovakia
Areteus s.r.o.
Trebišov, Slovak Republic, 07501, Slovakia
Diacrin s.r.o.
Bratislava, 84102, Slovakia
Noemis, s.r.o.
Nové Mesto nad Váhom, 91501, Slovakia
FUNKYSTUFF s.r.o.
Nové Zámky, 94001, Slovakia
MUDr. Jan Culak, s.r.o.
Prievidza, 97101, Slovakia
DIA-MED CENTRUM s.r.o.
Púchov, 02001, Slovakia
Tatratrial s.r.o.
Rožňava, 04801, Slovakia
Hospital Infanta Luisa
Seville, Andalusia, 41010, Spain
Clinica Juaneda
Palma de Mallorca, Balearic Islands, 07014, Spain
Corporació Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Marques De Valdecilla
Santander, Cantabria, 39011, Spain
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Instituto de Ciencias medicas
Alicante, 03004, Spain
Clinica San Pedro
Almería, 04001, Spain
Centre Medico Teknon
Barcelona, 08022, Spain
Hospital Clinico Universitario San Cecilio
Granada, 18012, Spain
Virgen de Las Nieves
Granada, 18014, Spain
Centro Especialidades San Jose Obrero (Barbarela)
Málaga, 29006, Spain
Clinica Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, 41003, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Policlinica Galileo
Teruel, 44002, Spain
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, ROC, Taiwan
Chi-Mei Medical Center
Tainan, 71004, Taiwan
Related Publications (3)
Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
PMID: 36894938DERIVEDCox DA, Wang H, Nicolay C, Bethel MA. Effect of expanded dulaglutide weekly doses (3.0 mg and 4.5 mg) on cardiovascular disease risk factors in participants with type 2 diabetes at increased cardiovascular disease risk: a post hoc analysis of the AWARD-11 study. Diabetes Obes Metab. 2022 Sep;24(9):1770-1778. doi: 10.1111/dom.14762. Epub 2022 May 29.
PMID: 35546790DERIVEDFrias JP, Bonora E, Nevarez Ruiz L, Li YG, Yu Z, Milicevic Z, Malik R, Bethel MA, Cox DA. Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11). Diabetes Care. 2021 Mar;44(3):765-773. doi: 10.2337/dc20-1473. Epub 2021 Jan 4.
PMID: 33397768DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2018
First Posted
April 11, 2018
Study Start
April 5, 2018
Primary Completion
May 28, 2019
Study Completion
October 10, 2019
Last Updated
June 12, 2020
Results First Posted
June 12, 2020
Record last verified: 2019-12-15
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.