AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3AWARD-11NCT03495102

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

A Phase 3 study testing Dulaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 208 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Dulaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,842 participants
Where
208 sitesin 16 countries
Study dates
5 Apr 2018to 10 Oct 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

208 sites in 16 countries.

208 sites in 16 countries

United States72 sites

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Montana Health Research

    Billings, Montana, 59102

  • Elite Clinical Trials LLLP

    Blackfoot, Idaho, 83221

  • Progressive Clinical Research

    Bountiful, Utah, 84010

  • Synexus- Chandler

    Chandler, Arizona, 85224

  • Metrolina Internal Medicine, P.A.

    Charlotte, North Carolina, 28207

  • Chattanooga Research and Medicine (CHARM)

    Chattanooga, Tennessee, 37404

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • StudyMetrix Research, LLC

    City of Saint Peters, Missouri, 63303

  • Aventiv Research

    Columbus, Ohio, 43213

  • ALL Medical Research, LLC

    Cooper City, Florida, 33024

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • The Corvallis Clinic P.C.

    Corvallis, Oregon, 97330

  • Dallas Diabetes Endocrine Center

    Dallas, Texas, 75230

  • Synexus/Clinical Research Advantage

    Evansville, Indiana, 47714

  • NECCR PrimaCare Research, LLC

    Fall River, Massachusetts, 02721

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • Valley Research

    Fresno, California, 93720

  • Prevea Clinic, Inc

    Green Bay, Wisconsin, 54303

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii, 96813

  • East West Medical Institute

    Honolulu, Hawaii, 96814

  • National Research Institute

    Huntington Park, California, 90255

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • Glacier View Research Institute

    Kalispell, Montana, 59901

  • Detweiler Family Medicine

    Lansdale, Pennsylvania, 19446

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • National Research Institute

    Los Angeles, California, 90057

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Urban Family Practice Associates, PC

    Marietta, Georgia, 30067

  • Synexus/Central Arizona Medical Associates, PC

    Mesa, Arizona, 85206

  • Southern Endocrinology and Associates PA

    Mesquite, Texas, 75149

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33175

  • PMG Research of Charleston, LLC

    Moncks Corner, South Carolina, 29461

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Diabetes & Endocrinology Consultants PC

    Morehead City, North Carolina, 28557

  • Saltzer Medical Group. P.A.

    Nampa, Idaho, 83686

  • Manhattan Medical Research

    New York, New York, 10016

  • Intend Research

    Norman, Oklahoma, 73069

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Pacific Research Partners, LLC

    Oakland, California, 94607

  • Advanced Research Institute

    Ogden, Utah, 84405

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Capital Clincial Research Center

    Olympia, Washington, 98502

  • Oviedo Medical Research

    Oviedo, Florida, 32765

  • National Research Institute

    Panorama City, California, 91402

  • In-Quest Medical Research, LLC- Peachtree Corners

    Peachtree Corners, Georgia, 30071

  • Central Phoenix Med Clinic LLC

    Phoenix, Arizona, 85020

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania, 15236

  • InterMed, PA

    Portland, Maine, 04101

  • Summit Research Network Inc

    Portland, Oregon, 97210

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23235

  • Sierra Clinical Research

    Roseville, California, 95661

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Care Access Research

    Santa Clarita, California, 91321

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62711

  • Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Premier Research

    Trenton, New Jersey, 08611

  • Troy Internal Medicine, PC

    Troy, Michigan, 48098

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Walla Walla Clinic

    Walla Walla, Washington, 99362

  • Diablo Clinical Research

    Walnut Creek, California, 94598

  • Sudir Bansal M.D. Inc.

    Warwick, Rhode Island, 02886

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • ClinPoint Trials, LLC

    Waxahachie, Texas, 75165

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

  • Iderc, P.L.C.

    West Des Moines, Iowa, 50265

  • Great Lakes Medical Research

    Westfield, New York, 14787

Other trials in United States

Argentina17 sites

  • AXISMED SRL - Bioclinica Research Network

    Buenos Aires, C1430CKE

  • Centro Medico CICEMO

    Caba, Buenos Aires, 1405

  • CEDIC-Centro de Investigaciones Clinicas

    Caba, Buenos Aires, 1425

  • Investigaciones Medicas IMOBA S.R.L.

    Caba, Buenos Aires, C1179AAB

  • Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

    Ciudad Autonoma de, Buenos Aires, C1119ACN

  • Mautalen Salud e Investigación - Servicio de Endocrinología

    Ciudad Autonoma de Buenos Air, C1128AAF

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ

  • Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425AGC

  • CENUDIAB

    Ciudad Autonoma de Buenos Aire, 1408

  • Centro Médico Viamonte

    Ciudad Autonoma de Buenos Aire, C1120AAC

  • Instituto Centenario

    Ciudad Autonoma de Buenos Aire, C1204AAD

  • Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff

    Ciudad Autonoma de Buenos Aire, C1205AAO

  • Instituto Medico Strusberg

    Córdoba, X5000EDC

  • Centro Medico Privado San Vicente Diabetes

    Córdoba, X5006CBI

  • Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

    Córdoba, X5008HHW

  • CIPADI

    Godoy Cruz, Mendoza Province, M5501ARP

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FZN

Other trials in Argentina

Romania17 sites

  • CMI DNBM Dr. Pop Lavinia

    Baia Mare, Maramureş, 430222

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL

    Brasov, 500283

  • Cabinetul Medical Nicodiab SRL

    Bucharest, 010507

  • Easydiet SRL

    Bucharest, 010627

  • SC Nutrilife SRL

    Bucharest, 013682

  • SC Medcon SRL

    Buzău, 120203

  • Centrul Medical Unirea SRL

    Cluj-Napoca, 400349

  • Cabinet Medical Urodiamed S.R.L.

    Craiova, 200349

  • Milena Sante SRL

    Galati, 800001

  • SC Olimpia Med SRL

    Iași, 700400

  • SC Gama Diamed SRL

    Mangalia, Constanța County, 905500

  • S. C. Grandmed S.R.L., Str.

    Oradea, Bihor County, 410159

  • SC Diabmed Dr Popescu Alexandrina SRL

    Ploieşti, Prahova, 100163

  • SC Dianutrilife Medica SRL

    Ploieşti, Prahova, 100561

  • Spitalul Judetean de Urgenta Satu Mare

    Satu Mare, Jud Satu-Mare, 440055

  • Cosamext SRL

    Târgu Mureş, Mureș County, 540098

  • Centrul Medical Dr. Negrisanu

    Timișoara, Timiș County, 300456

Other trials in Romania

Poland15 sites

  • NZOZ ZDROWIE Osteo-Medic

    Bialystok, 15-351

  • Poradnia Diabetologiczna SN ZOZ Lege Artis

    Bialystok, 15-404

  • NS ZOZ Osrodek Diabetologiczny " Popula"

    Bialystok, 15-445

  • Centrum Badan Klinicznych, PI House

    Gdansk, 80-546

  • NZOZ Salvia s.c.

    Katowice, 40-772

  • NZOZ Diab-Endo-Met

    Krakow, 31-261

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

    Lodz, 90-242

  • Gabinety Terpa

    Lublin, 20-333

  • NZOZ Przychodnia Specjalistyczna MEDICA

    Lublin, 20-538

  • Centrum Medyczne OMEDICA

    Poznan, 60-111

  • Praktyka Lekarska

    Poznan, 61-655

  • Nzoz Neuro - Kard

    Poznan, 61-853

  • NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek

    Ruda Śląska, 41-709

  • Centralny Szpital Kliniczny MSW

    Warsaw, 02-507

  • Regionalna Poradnia Diabetologiczna

    Wroclaw, 50-127

Other trials in Poland

Spain14 sites

  • Instituto de Ciencias medicas

    Alicante, 03004

  • Clinica San Pedro

    Almería, 04001

  • Centre Medico Teknon

    Barcelona, 08022

  • Hospital Clinico Universitario San Cecilio

    Granada, 18012

  • Virgen de Las Nieves

    Granada, 18014

  • Centro Especialidades San Jose Obrero (Barbarela)

    Málaga, 29006

  • Clinica Juaneda

    Palma de Mallorca, Balearic Islands, 07014

  • Hospital Universitario Quiron Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Corporació Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marques De Valdecilla

    Santander, Cantabria, 39011

  • Hospital Infanta Luisa

    Seville, Andalusia, 41010

  • Clinica Nuevas Tecnologias en Diabetes y Endocrinologia

    Seville, 41003

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Policlinica Galileo

    Teruel, 44002

Other trials in Spain

Greece10 sites

  • Laiko General Hospital of Athens

    Ampelokipoi, Attica, 11527

  • Gen Hospital of Athens G Gennimatas

    Athens, Attica, 11527

  • Athens Euroclinic

    Athens, 11521

  • G.Papanikolaou General Hospital

    Eksochi, Thessaloniki, 57010

  • University General Hospital of Larissa

    Larissa, 41110

  • Iatriko Palaiou Falirou, Medical Center

    Palaió Fáliro, Athens, 17562

  • Thermi Clinic

    Thermi, Thessaloniki, 57001

  • AHEPA Hospital

    Thessaloniki, 54636

  • Ippokrateio General Hospital of Thessaloniki

    Thessaloniki, 54639

  • Euromedica - General Clinic of Thessaloniki

    Thessaloniki, 54645

Other trials in Greece

Hungary9 sites

  • Szent Margit Rendelointezet

    Budapest, 1032

  • ClinDiab Kft.

    Budapest, 1089

  • Strazsahegy Medicina Bt.

    Budapest, 1171

  • TRANTOR 99 Bt.

    Budapest, 1213

  • Kenezy Gyula Korhaz es Rendelointezet

    Debrecen, Hajdú-Bihar, 4031

  • Studium Egeszseghaz Kft.

    Kalocsa, Bács-Kiskun county, 6300

  • Kanizsai Dorottya Korhaz

    Nagykanizsa, 8800

  • Grof Esterhazy Korhaz es Rendelointezeti Szakrendelo

    Pápa, Veszprém megye, 8500

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Israel9 sites

  • Maccabi Diabetes Clinic, Grand Canyon, North District, Haifa

    Haifa, 3299001

  • Linn Medical Center

    Haifa, 3515209

  • Hadassah Medical Center

    Jerusalem, 911201

  • Meir Medical Center

    Kfar Saba, 4428164

  • Clalit Health Services - Shuali Clinic

    Raanana, 4345204

  • ZIV Medical Center

    Safed, 13100

  • Sakhnin Community Clinic, Clalit Health Services

    Sakhnin, 3081000

  • Diabetes Medical Center (DMC)

    Tel Aviv, 6148002

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Italy9 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Policlinico Mater Domini

    Catanzaro, 88100

  • Fondazione Universitaria degli Studi G D'Annunzio

    Chieti, 66100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Florence, 50134

  • Ospedale Santa Maria Goretti

    Latina, 04100

  • Policlinico Giaccone

    Palermo, 90127

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, SI, 53100

  • Ospedale Civile Maggiore Borgo Trento

    Verona, 37126

Other trials in Italy

Slovakia9 sites

  • Diacrin s.r.o.

    Bratislava, 84102

  • Human care s.r.o.

    Košice, Slovak Republic, 04012

  • MediVet s.r.o.

    Malacky, Slovak Republic, 90101

  • Noemis, s.r.o.

    Nové Mesto nad Váhom, 91501

  • FUNKYSTUFF s.r.o.

    Nové Zámky, 94001

  • MUDr. Jan Culak, s.r.o.

    Prievidza, 97101

  • DIA-MED CENTRUM s.r.o.

    Púchov, 02001

  • Tatratrial s.r.o.

    Rožňava, 04801

  • Areteus s.r.o.

    Trebišov, Slovak Republic, 07501

Other trials in Slovakia

Austria6 sites

  • VIVIT Institut am LKH Feldkirch

    Feldkirch, Vorarlberg, 6800

  • Universitätsklinikum Graz

    Graz, Styria, 8036

  • Ordination Dr. Evelyn Fließer-Görzer

    Saint Stefan Ob Stainz, Styria, 8511

  • Landesklinikum Korneuburg-Stockerau, Standort Stockerau

    Stockerau, Lower Austria, 2000

  • KA Rudolfstiftung

    Vienna, 1030

  • Zentrum für klinische Studien Dr. Ursula Hanusch GmbH

    Vienna, 1060

Other trials in Austria

Canada6 sites

  • Aggarwal and Associates Ltd

    Brampton, Ontario, L6T 0G1

  • T. Nemtean Medicine Professional Corporation

    Mississauga, Ontario, L4Y 2N8

  • Bailey Clinic

    Red Deer, Alberta, T4N 6V7

  • Bluewater Clinical Research Group Inc

    Sarnia, Ontario, N7T 4X3

  • Stayner Medical Clinic

    Stayner, Ontario, L0M 1S0

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, Ontario, M9V 4B4

Other trials in Canada

Russia6 sites

  • Arkhangelsk Regional Clinical Hospital

    Arkhangelsk, 163045

  • Arkhangelsk the first city clinical hospital

    Arkhangelsk, 163045

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • City Hospital of Saint Martyr Elizabeth

    Saint Petersburg, 193257

  • SPb GUZ "Diagnostic Center #85"

    Saint Petersburg, 198255

  • Regional Clinical Hospital

    Saratov, Russian Federation, 410053

Other trials in Russia

Puerto Rico4 sites

  • Research and Cardiovascular Corp.

    Ponce, PR, 00717

  • Office: Dr. Luis Rivera Colon

    San Juan, PR, 00921

  • Clinical Research Puerto Rico, Inc.

    San Juan, 00909

  • GCM Medical Group PSC

    San Juan, 00917

Other trials in Puerto Rico

Taiwan3 sites

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • Taichung Veterans General Hospital

    Taichung, 40705, ROC

  • Chi-Mei Medical Center

    Tainan, 71004

Other trials in Taiwan

Mexico2 sites

  • Investigacion en Salud y Metabolismo S.C

    Chihuahua City, 31217

  • Hospital Univ. Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

Official title: 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.

Being tested
Dulaglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DulaglutideDrug

    Also called LY2189265

    Administered SC

Study groups in NCT03495102
Study groupRoleWhat they receive
Dulaglutide 1.5 mgActive comparatorDulaglutide 1.5 mg administered subcutaneously (SC) once a week.
Receives: Drug: Dulaglutide
Dulaglutide 3 mgExperimentalDulaglutide 3 mg administered SC once a week.
Receives: Drug: Dulaglutide
Dulaglutide 4.5 mgExperimentalDulaglutide 4.5 mg administered SC once a week.
Receives: Drug: Dulaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, Week 36

Secondary outcomes (6)

  1. 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).

    Measured: Baseline, Week 36

  2. Percentage of Participants Achieving HbA1c Target <7.0%

    Percentage of participants achieving HbA1c target <7.0%.

    Measured: Week 36

  3. 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).

    Measured: Baseline, Week 36

  4. 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.

    Measured: Week 36

  5. Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)

    Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).

    Measured: Week 4, Week 12, Week 36, Week 52

  6. 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.

    Measured: Week 4, Week 12, Week 36, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2018
  2. Study start5 Apr 2018
  3. Primary completion28 May 2019
  4. Study completion10 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,842 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03495102
Sponsor's protocol ID
16877
Other IDs
H9X-MC-GBGL, 2017-003490-33, 2017
Acronym
AWARD-11
Status last verified
15 Dec 2019
First submitted
2 Apr 2018
Last updated
12 Jun 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36894938

  • 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.

    PubMed 35546790

  • 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.

    PubMed 33397768

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dulaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 208 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 208 sites in United States, Argentina, Romania, Poland, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin A1c (HbA1c) From Baseline (time frame: Baseline, Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03495102, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.

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