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

May 28, 2020 updated by: Eli Lilly and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1842

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Medico Privado San Vicente Diabetes
      • Cordoba, Argentina, X5000EDC
        • Instituto Médico 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 Korhaz
      • Zalaegerszeg, Hungary, 8900
        • Zala Megyei Szent Rafael Korhaz
    • Bacs-Kiskun
      • Kalocsa, Bacs-Kiskun, Hungary, 6300
        • Studium Egeszseghaz Kft.
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4031
        • Kenezy Gyula Korhaz es Rendelointezet
    • 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 Județean de Urgență 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin A1c (HbA1c) From Baseline
Time Frame: 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).
Baseline, Week 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Body Weight From Baseline
Time Frame: 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).
Baseline, Week 36
Percentage of Participants Achieving HbA1c Target <7.0%
Time Frame: Week 36
Percentage of participants achieving HbA1c target <7.0%.
Week 36
Change in Fasting Serum Glucose (FSG) From Baseline
Time Frame: 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).
Baseline, Week 36
Rate of Documented Symptomatic Hypoglycemic Episodes
Time Frame: 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.
Week 36
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)
Time Frame: Week 4, Week 12, Week 36, Week 52
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
Time Frame: Week 4, Week 12, Week 36, Week 52
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.
Week 4, Week 12, Week 36, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 15, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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