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

NCT ID: NCT03495102

Last Updated: 2020-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1842 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2019-10-10

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dulaglutide 1.5 mg

Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.

Group Type: ACTIVE_COMPARATOR

Dulaglutide

Intervention Type: DRUG

Administered SC

Dulaglutide 3 mg

Dulaglutide 3 mg administered SC once a week.

Group Type: EXPERIMENTAL

Dulaglutide

Intervention Type: DRUG

Administered SC

Dulaglutide 4.5 mg

Dulaglutide 4.5 mg administered SC once a week.

Group Type: EXPERIMENTAL

Dulaglutide

Intervention Type: DRUG

Administered SC

Interventions

Dulaglutide

Administered SC

Intervention Type: DRUG

Other Intervention Names

LY2189265

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Synexus- Chandler

Chandler, Arizona, United States

Synexus/Central Arizona Medical Associates, PC

Mesa, Arizona, United States

Central Phoenix Med Clinic LLC

Phoenix, Arizona, United States

Arkansas Clinical Research

Little Rock, Arkansas, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Valley Research

Fresno, California, United States

National Research Institute

Huntington Park, California, United States

National Research Institute

Los Angeles, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Pacific Research Partners, LLC

Oakland, California, United States

National Research Institute

Panorama City, California, United States

Sierra Clinical Research

Roseville, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Care Access Research

Santa Clarita, California, United States

Encompass Clinical Research

Spring Valley, California, United States

University Clinical Investigators, Inc.

Tustin, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

ALL Medical Research, LLC

Cooper City, Florida, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

Suncoast Research Group, LLC

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Oviedo Medical Research

Oviedo, Florida, United States

Urban Family Practice Associates, PC

Marietta, Georgia, United States

In-Quest Medical Research, LLC- Peachtree Corners

Peachtree Corners, Georgia, United States

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, United States

East West Medical Institute

Honolulu, Hawaii, United States

Elite Clinical Trials LLLP

Blackfoot, Idaho, United States

Saltzer Medical Group. P.A.

Nampa, Idaho, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Synexus/Clinical Research Advantage

Evansville, Indiana, United States

Midwest Institute for Clinical Research

Indianapolis, Indiana, United States

Iderc, P.L.C.

West Des Moines, Iowa, United States

InterMed, PA

Portland, Maine, United States

MedStar Health Research Institute

Hyattsville, Maryland, United States

NECCR PrimaCare Research, LLC

Fall River, Massachusetts, United States

Aa Mrc Llc

Flint, Michigan, United States

Troy Internal Medicine, PC

Troy, Michigan, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

StudyMetrix Research, LLC

City of Saint Peters, Missouri, United States

Montana Health Research

Billings, Montana, United States

Glacier View Research Institute

Kalispell, Montana, United States

Premier Research

Trenton, New Jersey, United States

Manhattan Medical Research

New York, New York, United States

Great Lakes Medical Research

Westfield, New York, United States

Metrolina Internal Medicine, P.A.

Charlotte, North Carolina, United States

Diabetes & Endocrinology Consultants PC

Morehead City, North Carolina, United States

Aventiv Research

Columbus, Ohio, United States

Intend Research

Norman, Oklahoma, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

The Corvallis Clinic P.C.

Corvallis, Oregon, United States

Summit Research Network Inc

Portland, Oregon, United States

Heritage Valley Medical Group, Inc.

Beaver, Pennsylvania, United States

Detweiler Family Medicine

Lansdale, Pennsylvania, United States

Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, United States

Sudir Bansal M.D. Inc.

Warwick, Rhode Island, United States

PMG Research of Charleston, LLC

Moncks Corner, South Carolina, United States

Chattanooga Research and Medicine (CHARM)

Chattanooga, Tennessee, United States

Dallas Diabetes Endocrine Center

Dallas, Texas, United States

Southern Endocrinology and Associates PA

Mesquite, Texas, United States

Consano Clinical Research

Shavano Park, Texas, United States

Martin Diagnostic Clinic

Tomball, Texas, United States

ClinPoint Trials, LLC

Waxahachie, Texas, United States

Progressive Clinical Research

Bountiful, Utah, United States

Advanced Research Institute

Ogden, Utah, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Capital Clincial Research Center

Olympia, Washington, United States

Walla Walla Clinic

Walla Walla, Washington, United States

Wenatchee Valley Hospital & Clinics

Wenatchee, Washington, United States

Prevea Clinic, Inc

Green Bay, Wisconsin, United States

Centro Medico CICEMO

Caba, Buenos Aires, Argentina

CEDIC-Centro de Investigaciones Clinicas

Caba, Buenos Aires, Argentina

Investigaciones Medicas IMOBA S.R.L.

Caba, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

Ciudad Autonoma de, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

CIPADI

Godoy Cruz, Mendoza Province, Argentina

AXISMED SRL - Bioclinica Research Network

Buenos Aires, , Argentina

CENUDIAB

Ciudad Autonoma de Buenos Aire, , Argentina

Centro Médico Viamonte

Ciudad Autonoma de Buenos Aire, , Argentina

Instituto Centenario

Ciudad Autonoma de Buenos Aire, , Argentina

Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff

Ciudad Autonoma de Buenos Aire, , Argentina

Mautalen Salud e Investigación - Servicio de Endocrinología

Ciudad Autonoma de Buenos Air, , Argentina

Instituto Medico Strusberg

Córdoba, , Argentina

Centro Medico Privado San Vicente Diabetes

Córdoba, , Argentina

Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

Córdoba, , Argentina

Landesklinikum Korneuburg-Stockerau, Standort Stockerau

Stockerau, Lower Austria, Austria

Universitätsklinikum Graz

Graz, Styria, Austria

Ordination Dr. Evelyn Fließer-Görzer

Saint Stefan Ob Stainz, Styria, Austria

VIVIT Institut am LKH Feldkirch

Feldkirch, Vorarlberg, Austria

KA Rudolfstiftung

Vienna, , Austria

Zentrum für klinische Studien Dr. Ursula Hanusch GmbH

Vienna, , Austria

Bailey Clinic

Red Deer, Alberta, Canada

Aggarwal and Associates Ltd

Brampton, Ontario, Canada

T. Nemtean Medicine Professional Corporation

Mississauga, Ontario, Canada

Bluewater Clinical Research Group Inc

Sarnia, Ontario, Canada

Stayner Medical Clinic

Stayner, Ontario, Canada

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Ontario, Canada

Iatriko Palaiou Falirou, Medical Center

Palaió Fáliro, Athens, Greece

Laiko General Hospital of Athens

Ampelokipoi, Attica, Greece

Gen Hospital of Athens G Gennimatas

Athens, Attica, Greece

G.Papanikolaou General Hospital

Eksochi, Thessaloniki, Greece

Thermi Clinic

Thermi, Thessaloniki, Greece

Athens Euroclinic

Athens, , Greece

University General Hospital of Larissa

Larissa, , Greece

AHEPA Hospital

Thessaloniki, , Greece

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, , Greece

Euromedica - General Clinic of Thessaloniki

Thessaloniki, , Greece

Studium Egeszseghaz Kft.

Kalocsa, Bács-Kiskun county, Hungary

Kenezy Gyula Korhaz es Rendelointezet

Debrecen, Hajdú-Bihar, Hungary

Grof Esterhazy Korhaz es Rendelointezeti Szakrendelo

Pápa, Veszprém megye, Hungary

Szent Margit Rendelointezet

Budapest, , Hungary

ClinDiab Kft.

Budapest, , Hungary

Strazsahegy Medicina Bt.

Budapest, , Hungary

TRANTOR 99 Bt.

Budapest, , Hungary

Kanizsai Dorottya Korhaz

Nagykanizsa, , Hungary

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, , Hungary

Maccabi Diabetes Clinic, Grand Canyon, North District, Haifa

Haifa, , Israel

Linn Medical Center

Haifa, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Clalit Health Services - Shuali Clinic

Raanana, , Israel

ZIV Medical Center

Safed, , Israel

Sakhnin Community Clinic, Clalit Health Services

Sakhnin, , Israel

Diabetes Medical Center (DMC)

Tel Aviv, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Azienda Ospedaliera Universitaria Careggi

Florence, Florence, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

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

Siena, SI, Italy

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, , Italy

Policlinico Mater Domini

Catanzaro, , Italy

Fondazione Universitaria degli Studi G D'Annunzio

Chieti, , Italy

Ospedale Santa Maria Goretti

Latina, , Italy

Policlinico Giaccone

Palermo, , Italy

Ospedale Civile Maggiore Borgo Trento

Verona, , Italy

Hospital Univ. Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Investigacion en Salud y Metabolismo S.C

Chihuahua City, , Mexico

NZOZ ZDROWIE Osteo-Medic

Bialystok, , Poland

Poradnia Diabetologiczna SN ZOZ Lege Artis

Bialystok, , Poland

NS ZOZ Osrodek Diabetologiczny " Popula"

Bialystok, , Poland

Centrum Badan Klinicznych, PI House

Gdansk, , Poland

NZOZ Salvia s.c.

Katowice, , Poland

NZOZ Diab-Endo-Met

Krakow, , Poland

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

Lodz, , Poland

Gabinety Terpa

Lublin, , Poland

NZOZ Przychodnia Specjalistyczna MEDICA

Lublin, , Poland

Centrum Medyczne OMEDICA

Poznan, , Poland

Praktyka Lekarska

Poznan, , Poland

Nzoz Neuro - Kard

Poznan, , Poland

NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek

Ruda Śląska, , Poland

Centralny Szpital Kliniczny MSW

Warsaw, , Poland

Regionalna Poradnia Diabetologiczna

Wroclaw, , Poland

Research and Cardiovascular Corp.

Ponce, PR, Puerto Rico

Office: Dr. Luis Rivera Colon

San Juan, PR, Puerto Rico

Clinical Research Puerto Rico, Inc.

San Juan, , Puerto Rico

GCM Medical Group PSC

San Juan, , Puerto Rico

S. C. Grandmed S.R.L., Str.

Oradea, Bihor County, Romania

SC Gama Diamed SRL

Mangalia, Constanța County, Romania

Spitalul Judetean de Urgenta Satu Mare

Satu Mare, Jud Satu-Mare, Romania

CMI DNBM Dr. Pop Lavinia

Baia Mare, Maramureş, Romania

Cosamext SRL

Târgu Mureş, Mureș County, Romania

SC Diabmed Dr Popescu Alexandrina SRL

Ploieşti, Prahova, Romania

SC Dianutrilife Medica SRL

Ploieşti, Prahova, Romania

Centrul Medical Dr. Negrisanu

Timișoara, Timiș County, Romania

Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL

Brasov, , Romania

Cabinetul Medical Nicodiab SRL

Bucharest, , Romania

Easydiet SRL

Bucharest, , Romania

SC Nutrilife SRL

Bucharest, , Romania

SC Medcon SRL

Buzău, , Romania

Centrul Medical Unirea SRL

Cluj-Napoca, , Romania

Cabinet Medical Urodiamed S.R.L.

Craiova, , Romania

Milena Sante SRL

Galati, , Romania

SC Olimpia Med SRL

Iași, , Romania

Regional Clinical Hospital

Saratov, Russian Federation, Russia

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, , Russia

Arkhangelsk the first city clinical hospital

Arkhangelsk, , Russia

Rostov State Medical University

Rostov-on-Don, , Russia

City Hospital of Saint Martyr Elizabeth

Saint Petersburg, , Russia

SPb GUZ "Diagnostic Center #85"

Saint Petersburg, , Russia

Human care s.r.o.

Košice, Slovak Republic, Slovakia

MediVet s.r.o.

Malacky, Slovak Republic, Slovakia

Areteus s.r.o.

Trebišov, Slovak Republic, Slovakia

Diacrin s.r.o.

Bratislava, , Slovakia

Noemis, s.r.o.

Nové Mesto nad Váhom, , Slovakia

FUNKYSTUFF s.r.o.

Nové Zámky, , Slovakia

MUDr. Jan Culak, s.r.o.

Prievidza, , Slovakia

DIA-MED CENTRUM s.r.o.

Púchov, , Slovakia

Tatratrial s.r.o.

Rožňava, , Slovakia

Hospital Infanta Luisa

Seville, Andalusia, Spain

Clinica Juaneda

Palma de Mallorca, Balearic Islands, Spain

Corporació Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Hospital Universitario Marques De Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Quiron Madrid

Pozuelo de Alarcón, Madrid, Spain

Instituto de Ciencias medicas

Alicante, , Spain

Clinica San Pedro

Almería, , Spain

Centre Medico Teknon

Barcelona, , Spain

Hospital Clinico Universitario San Cecilio

Granada, , Spain

Virgen de Las Nieves

Granada, , Spain

Centro Especialidades San Jose Obrero (Barbarela)

Málaga, , Spain

Clinica Nuevas Tecnologias en Diabetes y Endocrinologia

Seville, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Policlinica Galileo

Teruel, , Spain

Chung Shan Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

Chi-Mei Medical Center

Tainan City, , Taiwan

Countries

United States; Argentina; Austria; Canada; Greece; Hungary; Israel; Italy; Mexico; Poland; Puerto Rico; Romania; Russia; Slovakia; Spain; Taiwan

References

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.

Reference Type: DERIVED

PMID: 36894938 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35546790 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33397768 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.lillytrialguide.com/en-US/studies/adult-type-2-diabetes/GBGL#?postal=

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

Other Identifiers

H9X-MC-GBGL

Identifier Type: OTHER

Identifier Source: secondary_id

2017-003490-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16877

Identifier Type: -

Identifier Source: org_study_id