Clinical trial NCT05803421: A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
Official title: A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Obesity
Overweight or Obesity
Overweight
Cardiovascular Diseases
Chronic Kidney Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 2749
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with type 2 diabetes mellitus (T2DM)
* Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.
* Have HbA1c at screening

  * ≥7.0% and ≤10.5% if background diabetes medication does not include a sulfonylurea, or
  * ≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea.
* Are on stable treatment of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 90 days before screening. Antihyperglycemic drugs may include metformin, SGLT-2 inhibitors, and/or sulfonylureas
* Have increased risk for cardiovascular (CV) events due to:

  * Coronary heart disease
  * Peripheral arterial disease, presumed to be of atherosclerotic origin
  * Cerebrovascular disease, presumed to be of atherosclerotic origin
  * Chronic kidney disease (CKD)
  * Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III
* Are of stable weight (± 5%) for at least 90 days prior to screening
* Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

* Have type 1 diabetes mellitus
* Have had chronic or acute pancreatitis any time prior to screening
* Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-VEGF inhibitors
* Have a known clinically significant gastric emptying abnormality
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) or aspartate aminotransferase (AST) enzyme level ≥5.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory
* Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure
* Have an eGFR \<15 mL/min/1.73 m2 as determined at screening
* Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days
* Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening

Primary outcomes:
measure: Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]
timeFrame: Baseline to End of the Study (Approximate Maximum 104 Weeks)
Secondary outcomes:
measure: Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)
timeFrame: Baseline to End of the Study (Approximately 104 Weeks)
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 52
measure: Change from Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 52
measure: Change from Baseline in Daily Average 7-point Self-monitoring Blood Glucose (SMBG) Profile
timeFrame: Baseline, Week 52
measure: Percentage of Participants with HbA1c Target Values Less Than (<)7.0% (53 mmol/mol)
timeFrame: Week 52
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Percent Change from Baseline Body Weight
timeFrame: Week 52
measure: Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score
timeFrame: Baseline, Week 52
measure: Pharmacokinetics (PK): Plasma Serum Concentrations of Orforglipron
timeFrame: Baseline through Week 52
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Pelham
country: United States
facility: Cahaba Research - Pelham
state: Alabama
city: Sheffield
country: United States
facility: Syed Research Consultants Llc
state: Alabama
city: Chandler
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Mesa
country: United States
facility: Aventiv Research
state: Arizona
city: Peoria
country: United States
facility: Arizona Liver Health - Peoria
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Phoenix
country: United States
facility: Absolute Clinical Research
state: Arizona
city: Sun City West
country: United States
facility: Clinical Research Institute of Arizona (CRI) - Sun City West
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Orange Grove Family Practice
state: Arizona
city: Little Rock
country: United States
facility: KLR Business Group, Inc. dba Arkansas Clinical Research
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Covina
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Escondido
country: United States
facility: Neighborhood Healthcare Institute of Health
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Los Alamitos
country: United States
facility: Pacific Clinical Studies
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: Norco
country: United States
facility: Infinity Clinical Research - Norco
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Research
state: California
city: San Carlos
country: United States
facility: LCGK Research
state: California
city: San Ramon
country: United States
facility: Norcal Endocrinology & Internal Medicine
state: California
city: Santa Ana
country: United States
facility: Velocity Clinical Research, Coastal Heart Medical Group
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Westlake Village
country: United States
facility: Millennium Clinical Trials
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Colorado Springs
country: United States
facility: Legacy Clinical Trials
state: Colorado
city: Hamden
country: United States
facility: CMR of Greater New Haven, LLC
state: Connecticut
city: Altamonte Springs
country: United States
facility: Orlando Heart & Vascular Institute
state: Florida
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Edgewater
country: United States
facility: Velocity Clinical Research, New Smyrna Beach
state: Florida
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research - Inverness
state: Florida
city: Jacksonville
country: United States
facility: Northeast Research Institute - Downtown Office
state: Florida
city: Leesburg
country: United States
facility: Clinical Site Partners Leesburg
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami
country: United States
facility: L&C Professional Medical Research Institute
state: Florida
city: Mount Dora
country: United States
facility: Adult Medicine of Lake County
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology
state: Florida
city: Tamarac
country: United States
facility: Care Access - Tamarac
state: Florida
city: Tampa
country: United States
facility: Baycare Clinical Research
state: Florida
city: Tampa
country: United States
facility: Precision Research Center
state: Florida
city: Tampa
country: United States
facility: Care Access - Tampa
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Lawrenceville
country: United States
facility: Balanced Life Health Care Solutions/SKYCRNG
state: Georgia
city: Macon
country: United States
facility: East Coast Institute for Research, LLC
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Nampa
country: United States
facility: Saltzer Health
state: Idaho
city: Rexburg
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Crystal Lake
country: United States
facility: Midwest CRC
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Health
state: Illinois
city: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
city: Avon
country: United States
facility: American Health Network of Indiana, LLC - Avon
state: Indiana
city: Brownsburg
country: United States
facility: Investigators Research Group
state: Indiana
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: Franklin
country: United States
facility: American Health Network of Indiana, LLC - Franklin
state: Indiana
city: Greenfield
country: United States
facility: American Health Network of Indiana, LLC - Greenfield
state: Indiana
city: Muncie
country: United States
facility: American Health Network of Indiana, LLC - Muncie
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes & Endocrinology
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Mulvane
state: Kansas
city: Bowling Green
country: United States
facility: Qualmedica Research
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Covington
country: United States
facility: Louisiana Heart Center - Convington
state: Louisiana
city: Lake Charles
country: United States
facility: Care Access - Lake Charles (Bayou Pines)
state: Louisiana
city: New Orleans
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Maryland Cardiovascular Specialists
state: Maryland
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Dearborn
country: United States
facility: Revival Research Institute
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Fayette
country: United States
facility: SKY Clinical Research Network Group - Hall
state: Mississippi
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Chesterfield
country: United States
facility: Diabetes and Endocrinology Specialists
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Kalispell
country: United States
facility: Logan Health Research
state: Montana
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Sunset
state: Nevada
city: Reno
country: United States
facility: Northern Nevada Endocrinology
state: Nevada
city: Reno
country: United States
facility: Renown South Meadows Medical Center
state: Nevada
city: East Brunswick
country: United States
facility: UniMed Center
state: New Jersey
city: Albuquerque
country: United States
facility: IMA Clinical Research
state: New Mexico
city: Albany
country: United States
facility: Albany Stratton VA Medical Center
state: New York
city: Binghamton
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Health Sciences University
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse
state: New York
city: Hartsdale
country: United States
facility: IMA Clinical Research Westchester
state: New York
city: Long Island City
country: United States
facility: NYC Research INC
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research
state: New York
city: New York
country: United States
facility: IMA Clinical Research Manhattan
state: New York
city: Vestal
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Fayetteville
country: United States
facility: Care Access - Fayetteville
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences, LLC
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc
state: North Carolina
city: Shelby
country: United States
facility: Carolina Research Center
state: North Carolina
city: Statesville
country: United States
facility: Accellacare - Piedmont
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington - 1917 Tradd Court
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Columbus
country: United States
facility: Remington-Davis, Inc
state: Ohio
city: Dublin
country: United States
facility: Centricity Research Dublin Multispecialty
state: Ohio
city: Moore
country: United States
facility: Tekton Research, Inc
state: Oklahoma
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Beaver
country: United States
facility: Heritage Valley Medical Group, Inc.
state: Pennsylvania
city: Newport
country: United States
facility: Capital Area Research - Newport
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Greenville
country: United States
facility: The Research Center of The Upstate
state: South Carolina
city: Mauldin
country: United States
facility: Care Access - Mauldin
state: South Carolina
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Tullahoma
country: United States
facility: Tennessee Center for Clinical Trials
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: Thyroid, Endocrinology, and Diabetes
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Denison
country: United States
facility: Cardio Voyage
state: Texas
city: Denison
country: United States
facility: Soma Clinical Trials
state: Texas
city: Forney
country: United States
facility: Care United Research
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Ft. Worth
state: Texas
city: Fort Worth
country: United States
facility: Valley Institute of Research - Fort Worth
state: Texas
city: Houston
country: United States
facility: Victorium Clinical Research - Houston
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Endocrine Ips, Pllc
state: Texas
city: Houston
country: United States
facility: Research Physicians Network, LLC
state: Texas
city: McAllen
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: San Antonio
country: United States
facility: Audie L Murphy VA Hospital
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: Tekton Research - Fredericksburg Road
state: Texas
city: San Antonio
country: United States
facility: VIP Trials
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Sherman
country: United States
facility: Sherman Clinical Research
state: Texas
city: Tomball
country: United States
facility: Northwest Houston Heart Center
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Wylie
country: United States
facility: Soma Clinical Trials
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: West Valley City
country: United States
facility: Kalo Clinical Research
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School (EVMS) Strelitz Diabetes Research Center
state: Virginia
city: Suffolk
country: United States
facility: Centricity Research Suffolk Family Medicine
state: Virginia
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Spokane
country: United States
facility: Multicare Institute for Research and Innovation
state: Washington
city: Tacoma
country: United States
facility: Universal Research Group
state: Washington
city: Green Bay
country: United States
facility: St. Vincent Hospital d/b/a Prevea Health
state: Wisconsin
city: Kenosha
country: United States
facility: Clinical Investigation Specialists
state: Wisconsin
city: Caba
country: Argentina
facility: Organizacion Medica de Investigacion
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar / Mindout Research
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Glenny Corp. S.A.
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Luján de Cuyo
country: Argentina
facility: Polo de Salud Vistalba
state: Mendoza
city: Granadero Baigorria
country: Argentina
facility: Centro de Investigaciones Clínicas Baigorria
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Médico Catamarca IMEC
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Clínicas Tucumán
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Buenos Aires Macula S.A
city: Buenos Aires
country: Argentina
facility: CEMEDIC
city: Buenos Aires
country: Argentina
facility: Cardiología Palermo
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: CENUDIAB
city: Córdoba
country: Argentina
facility: Hospital San Roque
city: Braunau
country: Austria
facility: Krankenhaus St. Josef Braunau
state: Oberösterreich
city: Linz
country: Austria
facility: Konventhospital der Barmherzigen Brüder Linz
state: Oberösterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Feldkirch
country: Austria
facility: VIVIT
state: Vorarlberg
city: Vienna
country: Austria
facility: Zentrum für klinische Studien Dr Hanusch Gmbh
state: Wien
city: Vienna
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
state: Wien
city: Sankt Stefan ob Stainz
country: Austria
facility: Private Practice - Dr. Evelyn Fliesser-Gorzer
city: Wien
country: Austria
facility: Klinik Landstraße
city: Wien
country: Austria
facility: Klinik Hietzing
city: Fortaleza
country: Brazil
facility: Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE
state: Ceará
city: Brasilia
country: Brazil
facility: Centro de Pesquisa Clinica do Brasil
state: Distrito Federal
city: Brasilia
country: Brazil
facility: Hospital Brasilia
state: Distrito Federal
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Acaraju
country: Brazil
facility: Centro de Pesquisa Clinica do Coracao
state: Sergipe
city: Campinas
country: Brazil
facility: Instituto de Pesquisa clinica de Campinas
state: São Paulo
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Campinas
country: Brazil
facility: Loema Instituto de Pesquisa Clinica
state: São Paulo
city: Santo André
country: Brazil
facility: Pesquisare Saude
state: São Paulo
city: Sao Paulo
country: Brazil
facility: CPCLIN
state: São Paulo
city: São José dos Campos
country: Brazil
facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin - Instituto Brasil de Pesquisa Clínica
city: São Paulo
country: Brazil
facility: NotreDame Intermedica Saude S.A
city: São Paulo
country: Brazil
facility: BR Trials - Ensaios Clinicos e Consultoria
city: São Paulo
country: Brazil
facility: Hospital 9 De Julho
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiology
city: Brno-Židenice
country: Czechia
facility: EFERTUS healthcare s.r.o.
state: Brno-město
city: Krnov
country: Czechia
facility: MUDr. Tomas Edelsberger
state: Moravskoslezský Kraj
city: Broumov
country: Czechia
facility: EDUMED - Broumov
state: Náchod
city: Jaroměř
country: Czechia
facility: EDUMED - Jaroměř
state: Náchod
city: Hranice
country: Czechia
facility: AIDIN VK s.r.o.
state: Olomoucký Kraj
city: Ostrava
country: Czechia
facility: Private Practice - Dr. Miroslav Koliba
state: Ostrava Město
city: Pardubice V
country: Czechia
facility: Diahelp s.r.o
state: Pardubice
city: Prague
country: Czechia
facility: MEDICON
state: Praha 4
city: Praha
country: Czechia
facility: Milan Kvapil s.r.o., Diabetologicka ambulance
state: Praha 4
city: Prague 5
country: Czechia
facility: EUC Klinika Praha
state: Praha 5
city: Prague
country: Czechia
facility: Nefromed
state: Praha 6
city: Praha 9 - Klanovice
country: Czechia
facility: MUDr. Barbora Diepoltova
state: Praha 9
city: Prague
country: Czechia
facility: FLEDIP s.r.o.
state: Praha, Hlavní Mešto
city: Praha 4
country: Czechia
facility: DiaVize s.r.o.
state: Praha, Hlavní Mešto
city: Brandys nad Labem
country: Czechia
facility: Diacentrum Brandys n.L. s.r.o.
state: Praha-východ
city: Náchod
country: Czechia
facility: EDUMED - Náchod
city: Olomouc
country: Czechia
facility: PreventaMed
city: Pilsen
country: Czechia
facility: Dialine - Interni a diabetologicka ambulance
city: Praha 4
country: Czechia
facility: MUDr. Michala Pelikanova s.r.o.
city: Praha 5
country: Czechia
facility: Praglandia s.r.o
city: Český Krumlov
country: Czechia
facility: Nemocnice Cesky Krumlov
city: Mühldorf
country: Germany
facility: Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte
state: Bayern
city: Pohlheim
country: Germany
facility: Diabetologische Schwerpunktpraxis Marck Linn Pickel
state: Hessen
city: Essen
country: Germany
facility: Praxis am Markt - Dr. Bernd Becker
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: SMO.MD GmbH
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
state: Sachsen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Diabetespraxis Dr. Braun
city: Eisenach
country: Germany
facility: Gemeinschaftspraxis für Diabetologie
city: Fulda
country: Germany
facility: MVZ im Altstadt-Carree Fulda GmbH
city: Hof
country: Germany
facility: Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
city: Rehlingen
country: Germany
facility: Praxis Dr. Veronika Wenzl-Bauer
city: Paleo Faliro
country: Greece
facility: Iatriko Paleou Falirou Medical Center
state: Attikí (Region)
city: Athens
country: Greece
facility: General Hospital of Athens "G. Gennimatas"
state: Attikí
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
state: Attikí
city: Chaidari
country: Greece
facility: Attikon General University Hospital
state: Attikí
city: Lamia
country: Greece
facility: General Hospital of Lamia
state: Fthiótida
city: Thessaloniki
country: Greece
facility: G. Gennimatas General Hospital of Thessaloniki
state: Thessaloníki
city: Guwahati
country: India
facility: Apollo Excelcare Hospital
state: Assam
city: Ahmedabad
country: India
facility: V.S. General Hospital
state: Gujarat
city: Surat
country: India
facility: Nirmal Hospital Pvt Ltd.
state: Gujarat
city: Bangalore
country: India
facility: Victoria Hospital, Bangalore Medical College And Research Institute
state: Karnataka
city: Bangalore
country: India
facility: Life Care Hospital and Research Centre
state: Karnataka
city: Hubli
country: India
facility: Karnataka Institute of Medical Sciences
state: Karnataka
city: Mumbai
country: India
facility: King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
state: Maharashtra
city: Nagpur
country: India
facility: Central India Cardiology and Research Institute
state: Maharashtra
city: Pune
country: India
facility: Chellaram Diabetes Institute
state: Maharashtra
city: Cuttack
country: India
facility: S C B Medical College and Hospital
state: Odisha
city: Jaipur
country: India
facility: Eternal Heart Care Center and Research Institute
state: Rajasthan
city: Chieti
country: Italy
facility: Università degli Studi Gabriele D' Annunzio
state: Abruzzo
city: Naples
country: Italy
facility: University of Naples Federico II
state: Campania
city: Trieste
country: Italy
facility: Azienda sanitaria universitaria giuliano isontina ASUGI Ospedale Maggiore- Università di Trieste
state: Friuli-Venezia Giulia
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese
state: Toscana
city: Perugia
country: Italy
facility: AO Santa Maria della Misericordia
state: Umbria
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
city: Catanzaro
country: Italy
facility: AOU Renato Dulbecco
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Kang-won-do
city: Wonju
country: Korea, Republic of
facility: Yonsei University-Wonju Severance Christian Hospital
state: Kang-won-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Kyǒnggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Gyeongsan-si
country: Korea, Republic of
facility: Yeungnam Univeristy Medical Center
state: Kyǒngsangbuk-do
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
state: Taejǒn-Kwangyǒkshi
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Ulsan-Kwangyǒkshi
city: Tijuana
country: Mexico
facility: Centro de Investigacion Cardiovascular y Metabólica
state: Baja California
city: León
country: Mexico
facility: Instituto Cardiovascular de León S.C.
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Diseno y Planeacion en Investigacion Medica
state: Jalisco
city: Guadalajara
country: Mexico
facility: Private Practice - Dr. Francisco Gerardo Padilla
state: Jalisco
city: Monterrey
country: Mexico
facility: Cardiolink Clin Trials
state: Nuevo León
city: Culiacán
country: Mexico
facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
state: Sinaloa
city: Ciudad Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
state: Tamaulipas
city: Aguascalientes
country: Mexico
facility: Clínica San Cosme
city: Aguascalientes
country: Mexico
facility: Centro de Investigación Cardiometabólica de Aguascalientes
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo Sc
city: Durango
country: Mexico
facility: Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
city: Querétaro
country: Mexico
facility: Centro de Estudios Clínicos de Querétaro (CECLIQ)
city: Caguas
country: Puerto Rico
facility: Centro de Endocrinologia y Nutricion
city: Dorado
country: Puerto Rico
facility: Dorado Medical Complex
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research
city: Ponce
country: Puerto Rico
facility: Research and Cardiovascular Corp.
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
city: San Juan
country: Puerto Rico
facility: Mgcendo Llc
city: Vega Baja
country: Puerto Rico
facility: Wellness clinical Research Vega Baja
city: Oradea
country: Romania
facility: Diabdana
state: Bihor
city: Oradea
country: Romania
facility: Centrul Medical Grandmed
state: Bihor
city: Brasov
country: Romania
facility: Mariodiab Clinic
state: Brașov
city: Brasov
country: Romania
facility: C.M.D.T.A. Neomed
state: Brașov
city: Bucharest
country: Romania
facility: Nicodiab
state: București
city: Bucharest
country: Romania
facility: Geea Medical Easy Diet
state: București
city: Bucharest
country: Romania
facility: Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
state: București
city: Bucharest
country: Romania
facility: Centrul Medical NutriLife
state: București
city: Bucharest
country: Romania
facility: Centrul Medical Endocrinologie si Diabet Dr. Paveliu
state: București
city: Târgu-Mureș
country: Romania
facility: Centrul Medical Mediab
state: Mureș
city: Ploiești
country: Romania
facility: Diabmed Dr. Popescu Alexandrina
state: Prahova
city: Timisoara
country: Romania
facility: Cabinet Medical Dr.Geru
state: Timiș
city: Bacău
country: Romania
facility: CMI Dr.Pletea Noemi SRL
city: Bacău
country: Romania
facility: SC Minimed SRL
city: Galați
country: Romania
facility: Milena Sante
city: Galați
country: Romania
facility: Diamed Obesity
city: Iași
country: Romania
facility: Centrul Medical Consultmed
city: Iași
country: Romania
facility: Cardiomed Iași
city: Satu Mare
country: Romania
facility: Clinica Korall
city: Lučenec
country: Slovakia
facility: IN-DIA
state: Banskobystrický Kraj
city: Bratislava
country: Slovakia
facility: Diacrin s.r.o.
state: Bratislavský Kraj
city: Malacky
country: Slovakia
facility: MediVet s.r.o.
state: Bratislavský Kraj
city: Kosice
country: Slovakia
facility: Human Care s.r.o.
state: Košický Kraj
city: Rožňava
country: Slovakia
facility: Tatratrial s.r.o.
state: Košický Kraj
city: Trebisov
country: Slovakia
facility: Areteus s.r.o.
state: Košický Kraj
city: Sabinov
country: Slovakia
facility: MEDI-DIA s.r.o.
state: Prešovský Kraj
city: Puchov
country: Slovakia
facility: DIA-MED CENTRUM s.r.o.
state: Trenčiansky Kraj
city: Trnava
country: Slovakia
facility: JAL
state: Trnavský Kraj
city: Bytca
country: Slovakia
facility: Diab - Int
state: Žilinský Kraj
city: Lubochna
country: Slovakia
facility: NEDÚ - Národný endokrinologický a diabetologický ústav n.o.
state: Žilinský Kraj
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña
state: A Coruña [La Coruña]
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias, Principado De
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Madrid
country: Spain
facility: Complejo Hospitalario Ruber Juan Bravo
state: Madrid, Comunidad De
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Seville
country: Spain
facility: Vithas Hospital Sevilla
state: Sevilla
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera
state: Valenciana, Comunitat
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Yuregir
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center
state: Adana
city: Pamukkale
country: Turkey
facility: Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre
state: Denizli
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi
city: Aydin
country: Turkey
facility: Adnan Menderes University Medical Faculty
city: Diyarbakir
country: Turkey
facility: Dicle Üniversitesi
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty
city: Malatya
country: Turkey
facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: