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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Dulaglutide

• Study Type: Interventional
• Enrollment (Actual): 1842
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1430CKE
    • AXISMED SRL - Bioclinica Research Network
  • Ciudad Autonoma De Buenos Air, Argentina, C1128AAF
    • Mautalen Salud e Investigación - Servicio de Endocrinología
  • Ciudad Autonoma de Buenos Aire, Argentina, C1120AAC
    • Centro Médico Viamonte
  • Ciudad Autonoma de Buenos Aire, Argentina, C1204AAD
    • Instituto Centenario
  • Ciudad Autonoma de Buenos Aire, Argentina, C1205AAO
    • Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff
  • Ciudad Autonoma de Buenos Aire, Argentina, 1408
    • CENUDIAB
  • Cordoba, Argentina, X5008HHW
    • Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
  • Cordoba, Argentina, X5006CBI
    • Centro Médico Privado San Vicente Diabetes
  • Cordoba, Argentina, X5000EDC
    • Instituto Medico Strusberg
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1179AAB
      • Investigaciones Medicas IMOBA S.R.L.
    • Caba, Buenos Aires, Argentina, 1405
      • Centro Medico CICEMO
    • Caba, Buenos Aires, Argentina, 1425
      • CEDIC-Centro de Investigaciones Clinicas
    • Ciudad Autonoma de, Buenos Aires, Argentina, C1119ACN
      • Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
    • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1425AGC
      • Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
    • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1056ABJ
      • Centro de Investigaciones Metabólicas (CINME)
    • Mar del Plata, Buenos Aires, Argentina, B7600FZN
      • Instituto de Investigaciones Clínicas Mar del Plata
  • Mendoza
    • Godoy Cruz, Mendoza, Argentina, M5501ARP
      • CIPADI
• Austria
  • Wien, Austria, 1030
    • KA Rudolfstiftung
  • Wien, Austria, 1060
    • Zentrum für klinische Studien Dr. Ursula Hanusch GmbH
  • Niederösterreich
    • Stockerau, Niederösterreich, Austria, 2000
      • Landesklinikum Korneuburg-Stockerau, Standort Stockerau
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Universitätsklinikum Graz
    • Saint Stefan Ob Stainz, Steiermark, Austria, 8511
      • Ordination Dr. Evelyn Fließer-Görzer
  • Vorarlberg
    • Feldkirch, Vorarlberg, Austria, 6800
      • VIVIT Institut am LKH Feldkirch
• Canada
  • Alberta
    • Red Deer, Alberta, Canada, T4N 6V7
      • Bailey Clinic
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and associates Ltd
    • Mississauga, Ontario, Canada, L4Y 2N8
      • T. Nemtean Medicine Professional Corporation
    • Sarnia, Ontario, Canada, N7t 4X3
      • Bluewater Clinical Research Group Inc
    • Stayner, Ontario, Canada, L0M 1S0
      • Stayner Medical Clinic
    • Toronto, Ontario, Canada, M9V 4B4
      • Dr. Anil K. Gupta Medicine Professional Corporation
• Greece
  • Athens, Greece, 11521
    • Athens Euroclinic
  • Larissa, Greece, 41110
    • University General Hospital of Larissa
  • Thessaloniki, Greece, 54645
    • Euromedica - General Clinic of Thessaloniki
  • Thessaloniki, Greece, 54636
    • AHEPA Hospital
  • Thessaloniki, Greece, 54639
    • Ippokrateio General Hospital of Thessaloniki
  • Athens
    • Palaio Faliro, Athens, Greece, 17562
      • Iatriko Palaiou Falirou, Medical Center
  • Attica
    • Ampelokipoi, Attica, Greece, 11527
      • Laiko General Hospital of Athens
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Gen Hospital of Athens G Gennimatas
  • Thessaloniki
    • Exohi, Thessaloniki, Greece, 57010
      • G.Papanikolaou General Hospital
    • Thermi, Thessaloniki, Greece, 57001
      • Thermi Clinic
• Hungary
  • Budapest, Hungary, 1089
    • ClinDiab Kft.
  • Budapest, Hungary, 1032
    • Szent Margit Rendelointézet
  • Budapest, Hungary, 1171
    • Strazsahegy Medicina Bt.
  • Budapest, Hungary, 1213
    • TRANTOR 99 Bt.
  • Nagykanizsa, Hungary, 8800
    • Kanizsai Dorottya Kórház
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Szent Rafael Kórház
  • Bacs-Kiskun
    • Kalocsa, Bacs-Kiskun, Hungary, 6300
      • Studium Egeszseghaz Kft.
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4031
      • Kenézy Gyula Kórház És Rendelőintézet
  • Veszprem
    • Papa, Veszprem, Hungary, 8500
      • Grof Esterhazy Korhaz es Rendelointezeti Szakrendelo
• Israel
  • Haifa, Israel, 3515209
    • Linn Medical Center
  • Haifa, Israel, 3299001
    • Maccabi Diabetes Clinic, Grand Canyon, North District, Haifa
  • Jerusalem, Israel, 911201
    • Hadassah Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Raanana, Israel, 4345204
    • Clalit Health Services - Shuali Clinic
  • Safed, Israel, 13100
    • Ziv Medical Center
  • Sakhnin, Israel, 3081000
    • Sakhnin Community Clinic, Clalit Health Services
  • Tel Aviv, Israel, 6148002
    • Diabetes Medical Center (DMC)
  • Tel Aviv Jaffa, Israel, 6423906
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bergamo, Italy, 24127
    • Azienda Ospedaliera Papa Giovanni Xxiii
  • Catanzaro, Italy, 88100
    • Policlinico Mater Domini
  • Chieti, Italy, 66100
    • Fondazione Universitaria degli Studi G D'Annunzio
  • Latina, Italy, 04100
    • Ospedale Santa Maria Goretti
  • Palermo, Italy, 90127
    • Policlinico Giaccone
  • Verona, Italy, 37126
    • Ospedale Civile Maggiore Borgo Trento
  • Florence
    • Firenze, Florence, Italy, 50134
      • Azienda Ospedaliera Universitaria Careggi
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas
  • SI
    • Siena, SI, Italy, 53100
      • A.O.U. Senese Policlinico Santa Maria alle Scotte
• Mexico
  • Chihuahua, Mexico, 31217
    • Investigacion en Salud y Metabolismo S.C
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Univ. Dr. Jose Eleuterio Gonzalez
• Poland
  • Bialystok, Poland, 15-351
    • Nzoz Zdrowie Osteo-Medic
  • Bialystok, Poland, 15-445
    • NS ZOZ Osrodek Diabetologiczny " Popula"
  • Bialystok, Poland, 15-404
    • Poradnia Diabetologiczna SN ZOZ Lege Artis
  • Gdansk, Poland, 80-546
    • Centrum Badan Klinicznych, PI House
  • Katowice, Poland, 40-772
    • NZOZ Salvia s.c.
  • Krakow, Poland, 31-261
    • NZOZ Diab-Endo-Met
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
  • Lublin, Poland, 20-538
    • NZOZ Przychodnia Specjalistyczna Medica
  • Lublin, Poland, 20-333
    • Gabinety TERPA
  • Poznan, Poland, 61-655
    • Praktyka Lekarska
  • Poznan, Poland, 61-853
    • Nzoz Neuro - Kard
  • Poznan, Poland, 60-111
    • Centrum Medyczne OMEDICA
  • Ruda Slaska, Poland, 41-709
    • NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSW
  • Wroclaw, Poland, 50-127
    • Regionalna Poradnia Diabetologiczna
• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Research and Cardiovascular Corp.
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico, Inc.
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group PSC
  • San Juan, Puerto Rico, 00921
    • Office: Dr. Luis Rivera Colon
• Romania
  • Brasov, Romania, 500283
    • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
  • Bucharest, Romania, 010507
    • Cabinetul Medical Nicodiab SRL
  • Bucuresti, Romania, 010627
    • Easydiet SRL
  • Bucuresti, Romania, 013682
    • SC Nutrilife SRL
  • Buzau, Romania, 120203
    • SC Medcon SRL
  • Cluj Napoca, Romania, 400349
    • Centrul Medical Unirea SRL
  • Craiova, Romania, 200349
    • Cabinet Medical Urodiamed S.R.L.
  • Galati, Romania, 800001
    • Milena Sante SRL
  • Iasi, Romania, 700400
    • SC Olimpia Med SRL
  • Bihor
    • Oradea, Bihor, Romania, 410159
      • S. C. Grandmed S.R.L., Str.
  • Constanta
    • Mangalia, Constanta, Romania, 905500
      • SC Gama Diamed SRL
  • Jud Satu-Mare
    • Satu-Mare, Jud Satu-Mare, Romania, 440055
      • Spitalul Judetean de Urgenta Satu Mare
  • Maramures
    • Baia Mare, Maramures, Romania, 430222
      • CMI DNBM Dr. Pop Lavinia
  • Mures
    • Targu Mures, Mures, Romania, 540098
      • Cosamext SRL
  • Prahova
    • Ploiesti, Prahova, Romania, 100561
      • SC Dianutrilife Medica SRL
    • Ploiesti, Prahova, Romania, 100163
      • SC Diabmed Dr Popescu Alexandrina SRL
  • Timis
    • Timisoara, Timis, Romania, 300456
      • Centrul Medical Dr. Negrisanu
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk Regional Clinical Hospital
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk the first city clinical hospital
  • Rostov-on-Don, Russian Federation, 344022
    • Rostov State Medical University
  • Saint Petersburg, Russian Federation, 198255
    • SPb GUZ "Diagnostic Center #85"
  • Saint Petersburg, Russian Federation, 193257
    • City Hospital of Saint Martyr Elizabeth
  • Saratov, Russian Federation, 410053
    • Regional Clinical Hospital
• Slovakia
  • Bratislava, Slovakia, 84102
    • Diacrin s.r.o.
  • Nove Mesto nad Vahom, Slovakia, 91501
    • NOEMIS, s.r.o.
  • Nove Zamky, Slovakia, 94001
    • Funkystuff s.r.o.
  • Prievidza, Slovakia, 97101
    • MUDr. Jan Culak, s.r.o.
  • Puchov, Slovakia, 02001
    • DIA-MED CENTRUM s.r.o.
  • Roznava, Slovakia, 04801
    • Tatratrial s.r.o.
  • Slovak Republic
    • Kosice, Slovak Republic, Slovakia, 04012
      • Human Care s.r.o.
    • Malacky, Slovak Republic, Slovakia, 90101
      • MediVet s.r.o.
    • Trebisov, Slovak Republic, Slovakia, 07501
      • ARETEUS s.r.o.
• Spain
  • Alicante, Spain, 03004
    • Instituto de Ciencias Médicas
  • Almeria, Spain, 04001
    • Clinica San Pedro
  • Barcelona, Spain, 08022
    • Centre Medico Teknon
  • Granada, Spain, 18012
    • Hospital Clinico Universitario San Cecilio
  • Granada, Spain, 18014
    • Virgen de Las Nieves
  • Malaga, Spain, 29006
    • Centro Especialidades San Jose Obrero (Barbarela)
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Seville, Spain, 41003
    • Clínica Nuevas Tecnologías en Diabetes y Endocrinología
  • Teruel, Spain, 44002
    • Policlinica Galileo
  • Andalucía
    • Sevilla, Andalucía, Spain, 41010
      • Hospital Infanta Luisa
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
  • Cantabria
    • Santander, Cantabria, Spain, 39011
      • Hospital Universitario Marques de Valdecilla
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07014
      • Clínica Juaneda
  • Madrid
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Universitario Quiron Madrid
• Taiwan
  • Taichung, Taiwan, 40705, ROC
    • Taichung Veterans General Hospital
  • Taichung City, Taiwan, 40201
    • Chung Shan Medical University Hospital
  • Tainan City, Taiwan, 71004
    • Chi-Mei Medical Center
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Synexus- Chandler
    • Mesa, Arizona, United States, 85206
      • Synexus/Central Arizona Medical Associates, PC
    • Phoenix, Arizona, United States, 85020
      • Central Phoenix Med Clinic LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Clinical Research
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Fresno, California, United States, 93720
      • Valley Research
    • Huntington Park, California, United States, 90255
      • National Research Institute
    • Los Angeles, California, United States, 90057
      • National Research Institute
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Oakland, California, United States, 94607
      • Pacific Research Partners, LLC
    • Panorama City, California, United States, 91402
      • National Research Institute
    • Roseville, California, United States, 95661
      • Sierra Clinical Research
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Santa Clarita, California, United States, 91321
      • Care Access Research
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Tustin, California, United States, 92780
      • University Clinical Investigators, Inc.
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Cooper City, Florida, United States, 33024
      • ALL Medical Research, LLC
    • Coral Gables, Florida, United States, 33134
      • Clinical Research of South Florida
    • Miami, Florida, United States, 33175
      • New Horizon Research Center
    • Miami, Florida, United States, 33135
      • Suncoast Research Group, LLC
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research
  • Georgia
    • Marietta, Georgia, United States, 30067
      • Urban Family Practice Associates, PC
    • Peachtree Corners, Georgia, United States, 30071
      • In-Quest Medical Research, LLC- Peachtree Corners
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Pacific Diabetes & Endocrine Center
    • Honolulu, Hawaii, United States, 96814
      • East West Medical Institute
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials LLLP
    • Nampa, Idaho, United States, 83686
      • Saltzer Medical Group. P.A.
  • Illinois
    • Springfield, Illinois, United States, 62711
      • Prairie Education and Research Cooperative
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Synexus/Clinical Research Advantage
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iderc, P.L.C.
  • Maine
    • Portland, Maine, United States, 04101
      • Intermed, PA
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Institute
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • NECCR Primacare Research, LLC
  • Michigan
    • Flint, Michigan, United States, 48504
      • Aa Mrc Llc
    • Troy, Michigan, United States, 48098
      • Troy Internal Medicine, PC
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research, LLC
  • Montana
    • Billings, Montana, United States, 59102
      • Montana Health Research
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Premier Research
  • New York
    • New York, New York, United States, 10016
      • Manhattan Medical Research
    • Westfield, New York, United States, 14787
      • Great Lakes Medical Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Metrolina Internal Medicine, P.A.
    • Morehead City, North Carolina, United States, 28557
      • Diabetes & Endocrinology Consultants PC
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Aventiv Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • The Corvallis Clinic P.C.
    • Portland, Oregon, United States, 97210
      • Summit Research Network Inc
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Medical Group, Inc.
    • Lansdale, Pennsylvania, United States, 19446
      • Detweiler Family Medicine
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Sudir Bansal M.D. Inc.
  • South Carolina
    • Moncks Corner, South Carolina, United States, 29461
      • PMG Research of Charleston, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Research and Medicine (CHARM)
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Endocrine Center
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology and Associates PA
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic
    • Waxahachie, Texas, United States, 75165
      • ClinPoint Trials, LLC
  • Utah
    • Bountiful, Utah, United States, 84010
      • Progressive Clinical Research
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
    • Richmond, Virginia, United States, 23235
      • Clinical Research Partners, LLC
  • Washington
    • Olympia, Washington, United States, 98502
      • Capital Clincial Research Center
    • Walla Walla, Washington, United States, 99362
      • Walla Walla Clinic
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital & Clinics
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54303
      • Prevea Clinic, Inc

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dulaglutide 1.5 mg; Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.	Drug: Dulaglutide; Administered SC; Other Names: LY2189265
Experimental: Dulaglutide 3 mg; Dulaglutide 3 mg administered SC once a week.	Drug: Dulaglutide; Administered SC; Other Names: LY2189265
Experimental: Dulaglutide 4.5 mg; Dulaglutide 4.5 mg administered SC once a week.	Drug: Dulaglutide; Administered SC; Other Names: LY2189265

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight From Baseline	Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 36
Percentage of Participants Achieving HbA1c Target <7.0%	Percentage of participants achieving HbA1c target <7.0%.	Week 36
Change in Fasting Serum Glucose (FSG) From Baseline	Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 36
Rate of Documented Symptomatic Hypoglycemic Episodes	Hypoglycemia was defined as blood glucose < 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.	Week 36
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)	Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).	Week 4, Week 12, Week 36, Week 52
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State	Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.	Week 4, Week 12, Week 36, Week 52

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Cox 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.
• Frias 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.

Helpful Links

• A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes (AWARD-11)

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): May 28, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: December 15, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide
• Other Study ID Numbers: 16877; H9X-MC-GBGL (Other Identifier: Eli Lilly and Company); 2017-003490-33 (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; Statistical Analysis Plan (SAP); Clinical Study Report (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