A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
- Registration Number
- NCT03495102
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1842
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dulaglutide 4.5 mg Dulaglutide Dulaglutide 4.5 mg administered SC once a week. Dulaglutide 3 mg Dulaglutide Dulaglutide 3 mg administered SC once a week. Dulaglutide 1.5 mg Dulaglutide Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
- Primary Outcome Measures
Name Time Method Change in Hemoglobin A1c (HbA1c) From Baseline Baseline, Week 36 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).
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving HbA1c Target <7.0% Week 36 Percentage of participants achieving HbA1c target \<7.0%.
Rate of Documented Symptomatic Hypoglycemic Episodes Week 36 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.
Change in Fasting Serum Glucose (FSG) From Baseline Baseline, Week 36 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).
Change in Body Weight From Baseline Baseline, Week 36 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).
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss) Week 4, Week 12, Week 36, Week 52 Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State Week 4, Week 12, Week 36, Week 52 Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.
Trial Locations
- Locations (206)
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Saltzer Medical Group. P.A.
🇺🇸Nampa, Idaho, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
InterMed, PA
🇺🇸Portland, Maine, United States
Glacier View Research Institute
🇺🇸Kalispell, Montana, United States
Dallas Diabetes Endocrine Center
🇺🇸Dallas, Texas, United States
Martin Diagnostic Clinic
🇺🇸Tomball, Texas, United States
Aggarwal and Associates Ltd
🇨🇦Brampton, Ontario, Canada
T. Nemtean Medicine Professional Corporation
🇨🇦Mississauga, Ontario, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
CEDIC-Centro de Investigaciones Clinicas
🇦🇷Caba, Buenos Aires, Argentina
City Hospital of Saint Martyr Elizabeth
🇷🇺Saint Petersburg, Russian Federation
Ippokrateio General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Kenezy Gyula Korhaz es Rendelointezet
🇭🇺Debrecen, Hajdu-Bihar, Hungary
VIVIT Institut am LKH Feldkirch
🇦🇹Feldkirch, Vorarlberg, Austria
ClinDiab Kft.
🇭🇺Budapest, Hungary
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
TRANTOR 99 Bt.
🇭🇺Budapest, Hungary
Laiko General Hospital of Athens
🇬🇷Ampelokipoi, Attica, Greece
Gen Hospital of Athens G Gennimatas
🇬🇷Athens, Attiki, Greece
G.Papanikolaou General Hospital
🇬🇷Exohi, Thessaloniki, Greece
Studium Egeszseghaz Kft.
🇭🇺Kalocsa, Bacs-Kiskun, Hungary
Kanizsai Dorottya Korhaz
🇭🇺Nagykanizsa, Hungary
Regionalna Poradnia Diabetologiczna
🇵🇱Wroclaw, Poland
SC Olimpia Med SRL
🇷🇴Iasi, Romania
Investigaciones Medicas IMOBA S.R.L.
🇦🇷Caba, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
Thermi Clinic
🇬🇷Thermi, Thessaloniki, Greece
Centrum Medyczne OMEDICA
🇵🇱Poznan, Poland
Cabinet Medical Urodiamed S.R.L.
🇷🇴Craiova, Romania
SPb GUZ "Diagnostic Center #85"
🇷🇺Saint Petersburg, Russian Federation
Regional Clinical Hospital
🇷🇺Saratov, Russian Federation
Human care s.r.o.
🇸🇰Kosice, Slovak Republic, Slovakia
Diacrin s.r.o.
🇸🇰Bratislava, Slovakia
Noemis, s.r.o.
🇸🇰Nove Mesto nad Vahom, Slovakia
Strazsahegy Medicina Bt.
🇭🇺Budapest, Hungary
NZOZ Diab-Endo-Met
🇵🇱Krakow, Poland
Arkhangelsk the first city clinical hospital
🇷🇺Arkhangelsk, Russian Federation
Centrum Badan Klinicznych, PI House
🇵🇱Gdansk, Poland
NZOZ Przychodnia Specjalistyczna MEDICA
🇵🇱Lublin, Poland
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
🇷🇴Brasov, Romania
Arkhangelsk Regional Clinical Hospital
🇷🇺Arkhangelsk, Russian Federation
MediVet s.r.o.
🇸🇰Malacky, Slovak Republic, Slovakia
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
ALL Medical Research, LLC
🇺🇸Cooper City, Florida, United States
Urban Family Practice Associates, PC
🇺🇸Marietta, Georgia, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Metrolina Internal Medicine, P.A.
🇺🇸Charlotte, North Carolina, United States
Heritage Valley Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
PMG Research of Charleston, LLC
🇺🇸Moncks Corner, South Carolina, United States
Szent Margit Rendelointezet
🇭🇺Budapest, Hungary
CIPADI
🇦🇷Godoy Cruz, Mendoza, Argentina
Iatriko Palaiou Falirou, Medical Center
🇬🇷Palaio Faliro, Athens, Greece
Grof Esterhazy Korhaz es Rendelointezeti Szakrendelo
🇭🇺Papa, Veszprem, Hungary
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Florence, Italy
Ospedale Santa Maria Goretti
🇮🇹Latina, Italy
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
University General Hospital of Larissa
🇬🇷Larissa, Greece
Euromedica - General Clinic of Thessaloniki
🇬🇷Thessaloniki, Greece
Zala Megyei Szent Rafael Korhaz
🇭🇺Zalaegerszeg, Hungary
Linn Medical Center
🇮🇱Haifa, Israel
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
🇵🇱Lodz, Poland
Ospedale Civile Maggiore Borgo Trento
🇮🇹Verona, Italy
Hospital Univ. Dr. Jose Eleuterio Gonzalez
🇲🇽Monterrey, Nuevo León, Mexico
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
NS ZOZ Osrodek Diabetologiczny " Popula"
🇵🇱Bialystok, Poland
Fondazione Universitaria degli Studi G D'Annunzio
🇮🇹Chieti, Italy
Diabetes Medical Center (DMC)
🇮🇱Tel Aviv, Israel
Policlinico Giaccone
🇮🇹Palermo, Italy
Investigacion en Salud y Metabolismo S.C
🇲🇽Chihuahua, Mexico
NZOZ ZDROWIE Osteo-Medic
🇵🇱Bialystok, Poland
Policlinico Mater Domini
🇮🇹Catanzaro, Italy
Milena Sante SRL
🇷🇴Galati, Romania
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taiwan
DIA-MED CENTRUM s.r.o.
🇸🇰Puchov, Slovakia
Chi-Mei Medical Center
🇨🇳Tainan City, Taiwan
Hospital Universitario Marques De Valdecilla
🇪🇸Santander, Cantabria, Spain
Clinica San Pedro
🇪🇸Almeria, Spain
MUDr. Jan Culak, s.r.o.
🇸🇰Prievidza, Slovakia
Tatratrial s.r.o.
🇸🇰Roznava, Slovakia
Clinica Juaneda
🇪🇸Palma de Mallorca, Islas Baleares, Spain
Centre Medico Teknon
🇪🇸Barcelona, Spain
Policlinica Galileo
🇪🇸Teruel, Spain
Summit Research Network Inc
🇺🇸Portland, Oregon, United States
Stayner Medical Clinic
🇨🇦Stayner, Ontario, Canada
Corporació Sanitaria Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
Hospital Infanta Luisa
🇪🇸Sevilla, Andalucía, Spain
Hospital Universitario Quiron Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Instituto de Ciencias medicas
🇪🇸Alicante, Spain
Virgen de Las Nieves
🇪🇸Granada, Spain
Centro Especialidades San Jose Obrero (Barbarela)
🇪🇸Malaga, Spain
Maccabi Diabetes Clinic, Grand Canyon, North District, Haifa
🇮🇱Haifa, Israel
Clalit Health Services - Shuali Clinic
🇮🇱Raanana, Israel
AHEPA Hospital
🇬🇷Thessaloniki, Greece
National Research Institute
🇺🇸Panorama City, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Valley Research
🇺🇸Fresno, California, United States
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
Synexus- Chandler
🇺🇸Chandler, Arizona, United States
Central Phoenix Med Clinic LLC
🇺🇸Phoenix, Arizona, United States
Synexus/Central Arizona Medical Associates, PC
🇺🇸Mesa, Arizona, United States
Arkansas Clinical Research
🇺🇸Little Rock, Arkansas, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Sierra Clinical Research
🇺🇸Roseville, California, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Care Access Research
🇺🇸Santa Clarita, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
In-Quest Medical Research, LLC- Peachtree Corners
🇺🇸Peachtree Corners, Georgia, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Oviedo Medical Research
🇺🇸Oviedo, Florida, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Elite Clinical Trials LLLP
🇺🇸Blackfoot, Idaho, United States
Synexus/Clinical Research Advantage
🇺🇸Evansville, Indiana, United States
Iderc, P.L.C.
🇺🇸West Des Moines, Iowa, United States
MedStar Health Research Institute
🇺🇸Hyattsville, Maryland, United States
NECCR PrimaCare Research, LLC
🇺🇸Fall River, Massachusetts, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Troy Internal Medicine, PC
🇺🇸Troy, Michigan, United States
Aa Mrc Llc
🇺🇸Flint, Michigan, 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
Diabetes & Endocrinology Consultants PC
🇺🇸Morehead City, North Carolina, United States
Aventiv Research
🇺🇸Columbus, Ohio, United States
Intend Research
🇺🇸Norman, Oklahoma, United States
The Corvallis Clinic P.C.
🇺🇸Corvallis, Oregon, United States
Preferred Primary Care Physicians
🇺🇸Pittsburgh, Pennsylvania, United States
Detweiler Family Medicine
🇺🇸Lansdale, Pennsylvania, United States
Sudir Bansal M.D. Inc.
🇺🇸Warwick, Rhode Island, United States
Chattanooga Research and Medicine (CHARM)
🇺🇸Chattanooga, Tennessee, United States
Southern Endocrinology and Associates PA
🇺🇸Mesquite, Texas, United States
Consano Clinical Research
🇺🇸Shavano Park, Texas, United States
ClinPoint Trials, LLC
🇺🇸Waxahachie, Texas, United States
Progressive Clinical Research
🇺🇸Bountiful, Utah, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Capital Clincial Research Center
🇺🇸Olympia, Washington, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Walla Walla Clinic
🇺🇸Walla Walla, Washington, United States
Centro Medico CICEMO
🇦🇷Caba, Buenos Aires, Argentina
Prevea Clinic, Inc
🇺🇸Green Bay, Wisconsin, United States
Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
🇦🇷Ciudad Autonoma de, Buenos Aires, Argentina
AXISMED SRL - Bioclinica Research Network
🇦🇷Buenos Aires, Argentina
CENUDIAB
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Instituto Medico Strusberg
🇦🇷Cordoba, Argentina
Centro Medico Privado San Vicente Diabetes
🇦🇷Cordoba, Argentina
Centro Médico Viamonte
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Mautalen Salud e Investigación - Servicio de Endocrinología
🇦🇷Ciudad Autonoma De Buenos Air, Argentina
Instituto Centenario
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
🇦🇷Cordoba, Argentina
Landesklinikum Korneuburg-Stockerau, Standort Stockerau
🇦🇹Stockerau, Niederösterreich, Austria
Universitätsklinikum Graz
🇦🇹Graz, Steiermark, Austria
Ordination Dr. Evelyn Fließer-Görzer
🇦🇹Saint Stefan Ob Stainz, Steiermark, Austria
KA Rudolfstiftung
🇦🇹Wien, Austria
Zentrum für klinische Studien Dr. Ursula Hanusch GmbH
🇦🇹Wien, Austria
Bluewater Clinical Research Group Inc
🇨🇦Sarnia, Ontario, Canada
Athens Euroclinic
🇬🇷Athens, Greece
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
ZIV Medical Center
🇮🇱Safed, Israel
A.O.U. Senese Policlinico Santa Maria alle Scotte
🇮🇹Siena, SI, Italy
Sakhnin Community Clinic, Clalit Health Services
🇮🇱Sakhnin, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv Jaffa, Israel
Poradnia Diabetologiczna SN ZOZ Lege Artis
🇵🇱Bialystok, Poland
Praktyka Lekarska
🇵🇱Poznan, Poland
NZOZ Salvia s.c.
🇵🇱Katowice, Poland
Gabinety Terpa
🇵🇱Lublin, Poland
Nzoz Neuro - Kard
🇵🇱Poznan, Poland
Centralny Szpital Kliniczny MSW
🇵🇱Warszawa, Poland
NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek
🇵🇱Ruda Slaska, Poland
Research and Cardiovascular Corp.
🇵🇷Ponce, Puerto Rico
Office: Dr. Luis Rivera Colon
🇵🇷San Juan, Puerto Rico
S. C. Grandmed S.R.L., Str.
🇷🇴Oradea, Bihor, Romania
SC Gama Diamed SRL
🇷🇴Mangalia, Constanta, Romania
Clinical Research Puerto Rico, Inc.
🇵🇷San Juan, Puerto Rico
Spitalul Judetean de Urgenta Satu Mare
🇷🇴Satu-Mare, Jud Satu-Mare, Romania
CMI DNBM Dr. Pop Lavinia
🇷🇴Baia Mare, Maramures, Romania
Cosamext SRL
🇷🇴Targu Mures, Mures, Romania
SC Diabmed Dr Popescu Alexandrina SRL
🇷🇴Ploiesti, Prahova, Romania
Centrul Medical Dr. Negrisanu
🇷🇴Timisoara, Timis, Romania
SC Dianutrilife Medica SRL
🇷🇴Ploiesti, Prahova, Romania
Easydiet SRL
🇷🇴Bucuresti, Romania
Cabinetul Medical Nicodiab SRL
🇷🇴Bucharest, Romania
SC Nutrilife SRL
🇷🇴Bucuresti, Romania
Centrul Medical Unirea SRL
🇷🇴Cluj Napoca, Romania
SC Medcon SRL
🇷🇴Buzau, Romania
Rostov State Medical University
🇷🇺Rostov-on-Don, Russian Federation
Areteus s.r.o.
🇸🇰Trebisov, Slovak Republic, Slovakia
FUNKYSTUFF s.r.o.
🇸🇰Nove Zamky, Slovakia
Hospital Clinico Universitario San Cecilio
🇪🇸Granada, Spain
Clinica Nuevas Tecnologias en Diabetes y Endocrinologia
🇪🇸Seville, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Wenatchee Valley Hospital & Clinics
🇺🇸Wenatchee, Washington, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
StudyMetrix Research, LLC
🇺🇸Saint Peters, Missouri, United States
Bailey Clinic
🇨🇦Red Deer, Alberta, Canada
GCM Medical Group PSC
🇵🇷San Juan, Puerto Rico
Pacific Diabetes & Endocrine Center
🇺🇸Honolulu, Hawaii, United States
East West Medical Institute
🇺🇸Honolulu, Hawaii, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
Montana Health Research
🇺🇸Billings, Montana, United States