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

Status: Completed
Location: See all (208) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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)

Locations
United States
Arkansas
Arkansas Clinical Research
Little Rock
Arizona
Synexus- Chandler
Chandler
Synexus/Central Arizona Medical Associates, PC
Mesa
Central Phoenix Med Clinic LLC
Phoenix
California
Anaheim Clinical Trials, LLC
Anaheim
Valley Research
Fresno
National Research Institute
Huntington Park
National Research Institute
Los Angeles
Catalina Research Institute, LLC
Montclair
Valley Clinical Trials, Inc.
Northridge
Pacific Research Partners, LLC
Oakland
National Research Institute
Panorama City
Sierra Clinical Research
Roseville
Artemis Institute for Clinical Research
San Diego
Care Access Research
Santa Clarita
Encompass Clinical Research
Spring Valley
University Clinical Investigators, Inc.
Tustin
Diablo Clinical Research
Walnut Creek
Connecticut
Chase Medical Research, LLC
Waterbury
Florida
ALL Medical Research, LLC
Cooper City
Clinical Research of South Florida
Coral Gables
New Horizon Research Center
Miami
Suncoast Research Group, LLC
Miami
Oviedo Medical Research
Oviedo
Georgia
Urban Family Practice Associates, PC
Marietta
In-Quest Medical Research, LLC- Peachtree Corners
Peachtree Corners
Hawaii
East West Medical Institute
Honolulu
Pacific Diabetes & Endocrine Center
Honolulu
Iowa
Iderc, P.L.C.
West Des Moines
Idaho
Elite Clinical Trials LLLP
Blackfoot
Saltzer Medical Group. P.A.
Nampa
Illinois
Prairie Education and Research Cooperative
Springfield
Indiana
Synexus/Clinical Research Advantage
Evansville
Midwest Institute for Clinical Research
Indianapolis
Massachusetts
NECCR PrimaCare Research, LLC
Fall River
Maryland
MedStar Health Research Institute
Hyattsville
Maine
InterMed, PA
Portland
Michigan
Aa Mrc Llc
Flint
Troy Internal Medicine, PC
Troy
Missouri
Clinical Research Professionals
Chesterfield
StudyMetrix Research, LLC
Saint Peters
Montana
Montana Health Research
Billings
Glacier View Research Institute
Kalispell
North Carolina
Metrolina Internal Medicine, P.A.
Charlotte
Diabetes & Endocrinology Consultants PC
Morehead City
New Jersey
Premier Research
Trenton
New York
Manhattan Medical Research
New York
Great Lakes Medical Research
Westfield
Ohio
Aventiv Research
Columbus
Oklahoma
Intend Research
Norman
IPS Research Company
Oklahoma City
Oregon
The Corvallis Clinic P.C.
Corvallis
Summit Research Network Inc
Portland
Pennsylvania
Heritage Valley Medical Group, Inc.
Beaver
Detweiler Family Medicine
Lansdale
Preferred Primary Care Physicians
Pittsburgh
Rhode Island
Sudir Bansal M.D. Inc.
Warwick
South Carolina
PMG Research of Charleston, LLC
Moncks Corner
Tennessee
Chattanooga Research and Medicine (CHARM)
Chattanooga
Texas
Dallas Diabetes Endocrine Center
Dallas
Southern Endocrinology and Associates PA
Mesquite
Consano Clinical Research
Shavano Park
Martin Diagnostic Clinic
Tomball
ClinPoint Trials, LLC
Waxahachie
Utah
Progressive Clinical Research
Bountiful
Advanced Research Institute
Ogden
Virginia
Manassas Clinical Research Center
Manassas
Clinical Research Partners, LLC
Richmond
Washington
Capital Clincial Research Center
Olympia
Walla Walla Clinic
Walla Walla
Wenatchee Valley Hospital & Clinics
Wenatchee
Wisconsin
Prevea Clinic, Inc
Green Bay
Other Locations
Argentina
AXISMED SRL - Bioclinica Research Network
Buenos Aires
CEDIC-Centro de Investigaciones Clinicas
Caba
Centro Medico CICEMO
Caba
Investigaciones Medicas IMOBA S.R.L.
Caba
Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
Ciudad Autonoma De
Mautalen Salud e Investigación - Servicio de Endocrinología
Ciudad Autonoma De Buenos Air
Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff
Ciudad Autonoma De Buenos Aire
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autonoma De Buenos Aire
Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma De Buenos Aire
Centro Médico Viamonte
Ciudad Autonoma De Buenos Aire
CENUDIAB
Ciudad Autonoma De Buenos Aire
Instituto Centenario
Ciudad Autonoma De Buenos Aire
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Cordoba
Centro Medico Privado San Vicente Diabetes
Cordoba
Instituto Medico Strusberg
Cordoba
CIPADI
Godoy Cruz
Instituto de Investigaciones Clinicas Mar del Plata
Mar Del Plata
Austria
VIVIT Institut am LKH Feldkirch
Feldkirch
Universitätsklinikum Graz
Graz
Ordination Dr. Evelyn Fließer-Görzer
Saint Stefan Ob Stainz
Landesklinikum Korneuburg-Stockerau, Standort Stockerau
Stockerau
KA Rudolfstiftung
Wien
Zentrum für klinische Studien Dr. Ursula Hanusch GmbH
Wien
Canada
Aggarwal and Associates Ltd
Brampton
T. Nemtean Medicine Professional Corporation
Mississauga
Bailey Clinic
Red Deer
Bluewater Clinical Research Group Inc
Sarnia
Stayner Medical Clinic
Stayner
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto
Greece
Laiko General Hospital of Athens
Ampelokipoi
Athens Euroclinic
Athens
Gen Hospital of Athens G Gennimatas
Athens
G.Papanikolaou General Hospital
Exohi
University General Hospital of Larissa
Larissa
Iatriko Palaiou Falirou, Medical Center
Palaio Faliro
Thermi Clinic
Thermi
AHEPA Hospital
Thessaloniki
Euromedica - General Clinic of Thessaloniki
Thessaloniki
Ippokrateio General Hospital of Thessaloniki
Thessaloniki
Hungary
ClinDiab Kft.
Budapest
Strazsahegy Medicina Bt.
Budapest
Szent Margit Rendelointezet
Budapest
TRANTOR 99 Bt.
Budapest
Kenezy Gyula Korhaz es Rendelointezet
Debrecen
Studium Egeszseghaz Kft.
Kalocsa
Kanizsai Dorottya Korhaz
Nagykanizsa
Grof Esterhazy Korhaz es Rendelointezeti Szakrendelo
Papa
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg
Israel
Linn Medical Center
Haifa
Maccabi Diabetes Clinic, Grand Canyon, North District, Haifa
Haifa
Hadassah Medical Center
Jerusalem
Meir Medical Center
Kfar Saba
Clalit Health Services - Shuali Clinic
Raanana
ZIV Medical Center
Safed
Sakhnin Community Clinic, Clalit Health Services
Sakhnin
Diabetes Medical Center (DMC)
Tel Aviv
Tel Aviv Sourasky Medical Center
Tel Aviv Jaffa
Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
Policlinico Mater Domini
Catanzaro
Fondazione Universitaria degli Studi G D'Annunzio
Chieti
Azienda Ospedaliera Universitaria Careggi
Firenze
Ospedale Santa Maria Goretti
Latina
Policlinico Giaccone
Palermo
Istituto Clinico Humanitas
Rozzano
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena
Ospedale Civile Maggiore Borgo Trento
Verona
Mexico
Investigacion en Salud y Metabolismo S.C
Chihuahua
Hospital Univ. Dr. Jose Eleuterio Gonzalez
Monterrey
Poland
NS ZOZ Osrodek Diabetologiczny Popula
Bialystok
NZOZ ZDROWIE Osteo-Medic
Bialystok
Poradnia Diabetologiczna SN ZOZ Lege Artis
Bialystok
Centrum Badan Klinicznych, PI House
Gdansk
NZOZ Salvia s.c.
Katowice
NZOZ Diab-Endo-Met
Krakow
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz
Gabinety Terpa
Lublin
NZOZ Przychodnia Specjalistyczna MEDICA
Lublin
Centrum Medyczne OMEDICA
Poznan
Nzoz Neuro - Kard
Poznan
Praktyka Lekarska
Poznan
NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek
Ruda Slaska
Centralny Szpital Kliniczny MSW
Warszawa
Regionalna Poradnia Diabetologiczna
Wroclaw
Puerto Rico
Research and Cardiovascular Corp.
Ponce
Clinical Research Puerto Rico, Inc.
San Juan
GCM Medical Group PSC
San Juan
Office: Dr. Luis Rivera Colon
San Juan
Romania
CMI DNBM Dr. Pop Lavinia
Baia Mare
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov
Cabinetul Medical Nicodiab SRL
Bucharest
Easydiet SRL
Bucuresti
SC Nutrilife SRL
Bucuresti
SC Medcon SRL
Buzau
Centrul Medical Unirea SRL
Cluj Napoca
Cabinet Medical Urodiamed S.R.L.
Craiova
Milena Sante SRL
Galati
SC Olimpia Med SRL
Iasi
SC Gama Diamed SRL
Mangalia
S. C. Grandmed S.R.L., Str.
Oradea
SC Diabmed Dr Popescu Alexandrina SRL
Ploiesti
SC Dianutrilife Medica SRL
Ploiesti
Spitalul Judetean de Urgenta Satu Mare
Satu-mare
Cosamext SRL
Targu Mures
Centrul Medical Dr. Negrisanu
Timisoara
Russian Federation
Arkhangelsk Regional Clinical Hospital
Arkhangelsk
Arkhangelsk the first city clinical hospital
Arkhangelsk
Rostov State Medical University
Rostov-on-don
City Hospital of Saint Martyr Elizabeth
Saint Petersburg
SPb GUZ Diagnostic Center #85
Saint Petersburg
Regional Clinical Hospital
Saratov
Slovakia
Diacrin s.r.o.
Bratislava
Human care s.r.o.
Kosice
MediVet s.r.o.
Malacky
Noemis, s.r.o.
Nove Mesto Nad Vahom
FUNKYSTUFF s.r.o.
Nove Zamky
MUDr. Jan Culak, s.r.o.
Prievidza
DIA-MED CENTRUM s.r.o.
Puchov
Tatratrial s.r.o.
Roznava
Areteus s.r.o.
Trebisov
Spain
Instituto de Ciencias medicas
Alicante
Clinica San Pedro
Almeria
Centre Medico Teknon
Barcelona
Hospital Clinico Universitario San Cecilio
Granada
Virgen de Las Nieves
Granada
Centro Especialidades San Jose Obrero (Barbarela)
Malaga
Clinica Juaneda
Palma De Mallorca
Hospital Universitario Quiron Madrid
Pozuelo De Alarcon
Corporació Sanitaria Parc Tauli
Sabadell
Hospital Universitario Marques De Valdecilla
Santander
Hospital Infanta Luisa
Sevilla
Hospital Universitario Virgen Macarena
Sevilla
Clinica Nuevas Tecnologias en Diabetes y Endocrinologia
Seville
Policlinica Galileo
Teruel
Taiwan
Taichung Veterans General Hospital
Taichung
Chung Shan Medical University Hospital
Taichung City
Chi-Mei Medical Center
Tainan City
Time Frame
Start Date: April 5, 2018
Completion Date: October 10, 2019
Participants
Target number of participants: 1842
Treatments
Active Comparator: Dulaglutide 1.5 mg
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
Experimental: Dulaglutide 3 mg
Dulaglutide 3 mg administered SC once a week.
Experimental: Dulaglutide 4.5 mg
Dulaglutide 4.5 mg administered SC once a week.
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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