Clinical trial NCT03420781: A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
Official title: A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastroparesis
Diabetes Mellitus
Keywords: diabetic gastroparesis
vomiting
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 467
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: A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.


Eligibility criteria: Inclusion Criteria:

* Participants are eligible to be included in the study only if all the following criteria apply:
* Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
* Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
* In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

Exclusion Criteria:

* Participants are excluded from the study if any of the following criteria apply:
* Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
* Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
* Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
* Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease

Primary outcomes:
measure: Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study
measure: Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
timeFrame: Week 6 to Week 12
Secondary outcomes:
measure: Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
measure: Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
measure: Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
measure: Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
measure: Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
measure: Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period
timeFrame: Week 37 to Week 40
measure: Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
measure: Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
measure: Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
measure: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
timeFrame: First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks)
measure: Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
timeFrame: Up to 46 weeks
measure: Number of Participants With Clinically Meaningful Trends for Vital Signs
timeFrame: Up to 46 weeks
measure: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
timeFrame: Up to 46 weeks
measure: Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
timeFrame: Up to 46 weeks
measure: Number of Participants With Anti-relamorelin Antibody Testing Results
timeFrame: Up to 46 weeks
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center, LLC
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialist of the South East
state: Alabama
city: Foley
country: United States
facility: G & L Research, LLC
state: Alabama
city: Mobile
country: United States
facility: Alabama Medical Group, PC
state: Alabama
city: Chandler
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Clinical LLC.
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Searcy
country: United States
facility: Unity Health - Searcy Medical Center
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Chula Vista
country: United States
facility: GW Research Inc
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Costa Mesa
country: United States
facility: Aurora Care Clinic, LLC
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc.
state: California
city: Garden Grove
country: United States
facility: VVCRD Research
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute, Inc.
state: California
city: Los Angeles
country: United States
facility: Angel City Research Inc.
state: California
city: Poway
country: United States
facility: TriWest Research Associates
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Upland
country: United States
facility: Upland Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
state: Colorado
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County, P.C.
state: Connecticut
city: Washington
country: United States
facility: TrialSpark, Inc.
state: District of Columbia
city: Clearwater
country: United States
facility: Innovative Research of West FL, Inc.
state: Florida
city: Clearwater
country: United States
facility: West Central Gastroenterology
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Cooper City
country: United States
facility: ALL Medical Research LLC
state: Florida
city: Cutler Bay
country: United States
facility: Top Medical Research
state: Florida
city: Hialeah
country: United States
facility: Palmetto Research, LLC
state: Florida
city: Homestead
country: United States
facility: Vida Clinical Trials
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research, LLC.
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group LLC
state: Florida
city: Miami
country: United States
facility: APF Research LLC
state: Florida
city: Miami
country: United States
facility: AMPM Research Clinic
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: American Research Institute, Inc
state: Florida
city: Pinellas Park
country: United States
facility: Synexus
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Buford
country: United States
facility: Gwinnett Research Institute, LLC
state: Georgia
city: Carnesville
country: United States
facility: Summit Clinical Research, LLC.
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta LLC
state: Georgia
city: Riverdale
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Suwanee
country: United States
facility: Clinical Research Consultants of Atlanta
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center, PA
state: Idaho
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Jeffersonville
country: United States
facility: American Research, LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Pratt
country: United States
facility: Health Science Research Center
state: Kansas
city: Shawnee Mission
country: United States
facility: WestGlen Gastrointestinal Consultants
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center - Digestive Health
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic
state: Kansas
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Wichita
country: United States
facility: Via Christi Clinic, PA
state: Kansas
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Bastrop
country: United States
facility: Delta Research Partners
state: Louisiana
city: Bossier City
country: United States
facility: WK Physicians Network
state: Louisiana
city: Crowley
country: United States
facility: Avant Research Associates LLC
state: Louisiana
city: Houma
country: United States
facility: Cronola LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA, LLC
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Metairie
country: United States
facility: New Orleans Research Institute - Metropolitan Gastroenterology Associates
state: Louisiana
city: West Monroe
country: United States
facility: Clinical Trials of America, Inc.
state: Louisiana
city: Bowie
country: United States
facility: Trialspark - Silverman
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Frederick
country: United States
facility: Frederick Gastroenterology Associates, PA an Elligo Health Research Site
state: Maryland
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology Associates, P.A.
state: Maryland
city: Rockville
country: United States
facility: Meridian Clinical Research, LLC
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies, PLLC.
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Dearborn
country: United States
facility: Vida Clinical Studies
state: Michigan
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Hamtramck
country: United States
facility: National Clinical, LLC
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan
state: Michigan
city: Coon Rapids
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Omaha
country: United States
facility: Methodist Physicians Clinic Diabetes and Endocrine Specialists
state: Nebraska
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Las Vegas
country: United States
facility: Digestive Disease Specialists
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Brick
country: United States
facility: Garden State Endocrinology
state: New Jersey
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources, Inc.
state: New Mexico
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group LLP
state: New York
city: Jamaica
country: United States
facility: Synexus Clinical Research US, Inc.
state: New York
city: Johnson City
country: United States
facility: United Health Services Hospitals, Inc.
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Concord
country: United States
facility: Carolina Digestive Health Associates, PA
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials
state: North Carolina
city: Kinston
country: United States
facility: Vidant Multispeciality Clinic - Kinston
state: North Carolina
city: Morehead City
country: United States
facility: Diabetes and Endocrinology Consultants, PC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research Salisbury
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Beavercreek
country: United States
facility: Dayton Gastroenterology, Inc.
state: Ohio
city: Canton
country: United States
facility: Diabetes & Endocrinology Associates of Stark County, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US - Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Endocrinology Research Associates, Inc.
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University, Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Dayton
country: United States
facility: CIC America Clinical Inquest Center Ltd.
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Franklin
country: United States
facility: Premier Clinical Research d.b.a. STAT Research
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc
state: Oklahoma
city: Oklahoma City
country: United States
facility: Memorial Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic, LLC
state: Oregon
city: Levittown
country: United States
facility: Family Medical Associates, Research Department
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Endocrinology Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Smithfield
country: United States
facility: Montgomery Medical, Inc.
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc.
state: South Carolina
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc
state: South Carolina
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Gastroenterology Associates, PA
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Chattanooga
country: United States
facility: Clinsearch
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Austin
country: United States
facility: Avant Research Associates,LLC
state: Texas
city: Carrollton
country: United States
facility: ClinRx Research, LLC
state: Texas
city: Dallas
country: United States
facility: Synexus Clinical Research US, Inc.
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc., Research Center
state: Texas
city: Houston
country: United States
facility: Rodriguez Clinical Trials
state: Texas
city: Houston
country: United States
facility: Amir Ali Hassan, MD, PA
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research US, Inc.
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute, Inc.
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Fairfax
country: United States
facility: Verity Research Inc.
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Centre
state: Virginia
city: Woodbridge
country: United States
facility: Cardinal Internal Medicine Associates, PC
state: Virginia
city: Tacoma
country: United States
facility: Washington Gastroenterology PLLC
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: C.a.b.a.
country: Argentina
facility: Maffei Centro Medico-Investigacion Clinica Aplicada
state: Buenos Aires Province
city: Caba
country: Argentina
facility: Hospital Sirio Libanes
state: Buenos Aires Province
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
state: Buenos Aires Province
city: Córdoba
country: Argentina
facility: Instituto Privado de Investigaciones Clínicas de Córdoba
state: Cordoba
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas de Rosario
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
state: Tucuman
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CIPREC
city: Corrientes
country: Argentina
facility: Centro Universitario de Investigacion en Farmacologia Clinic
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Sankt Stefan ob Stainz
country: Austria
facility: Ordination
state: Styria
city: Feldkirch'
country: Austria
facility: VIVIT Institute, am LKH Feldkirch
state: Vorarlberg
city: Salzburg
country: Austria
facility: Privatklinik Wehrle-Diakonissen
city: Steyr
country: Austria
facility: Landeskrankenhaus Steyr
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,
state: Antwerp
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
city: Brugge
country: Belgium
facility: AZ Sint Lucas Brugge
state: West-Vlaanderen
city: Fortaleza
country: Brazil
facility: Hospital Universitário Walter Cantídio
state: Ceara
city: Fortaleza
country: Brazil
facility: Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology
state: Ceará
city: Brasilia
country: Brazil
facility: Centro de Pesquisa Clinica do Brasil
state: Distrito Federal
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Instituto Catarinense de Endocrinologia e Diabetes (ICED)
state: Santa Catarina
city: Campinas
country: Brazil
facility: Scentryphar Pesquisa Clinica Ltda
state: Sao Paulo
city: Campinas
country: Brazil
facility: Instituto de Pesquisa Clinica de Campinas
state: Sao Paulo
city: Santa Cecília
country: Brazil
facility: CPQuali Pesquisa Clinica Ltda
state: São Paulo
city: Belém
country: Brazil
facility: Hospital Universitário João de Barros Barreto
city: Sao Paulo
country: Brazil
facility: IPEC-Instituto de Pesquisa Clinica
city: Byala
country: Bulgaria
facility: MHAT Yuliya Vrevska Byala
state: Ruse
city: Plovdiv
country: Bulgaria
facility: UMHAT - Kaspela- EOOD
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Diabetes Institute
state: Alberta
city: Red Deer
country: Canada
facility: Central Alberta Research Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Bridgewater
country: Canada
facility: South Shore Medical Arts
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates
state: Ontario
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Medellin
country: Colombia
facility: Centro Cardiovascular Colombiano Clínica Santa María
state: Antioquia
city: Medellín
country: Colombia
facility: Rodrigo Botero S.A.S.
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Cardiovascular y de Diabetes
state: Atlantico
city: Barranquilla
country: Colombia
facility: Fundacion BIOS
state: Atlantico
city: Bogotá
country: Colombia
facility: Endocare Ltda.
state: Cundinamarca
city: Zipaquirá
country: Colombia
facility: Healthy Medical Center
state: Cundinamarca
city: Bogota
country: Colombia
facility: Medplus Medicina Prepagada
state: Distrito Capital De Bogota
city: Teusaquillo
country: Colombia
facility: Asociación Colombiana de Diabetes
state: Distrito Capital De Bogotá
city: Pereira
country: Colombia
facility: Fundacion Centro de Investigaciones Clinicas CARDIOMET
state: Risaralda
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A.
state: Valle Del Cauca
city: Cali
country: Colombia
facility: IPS Centro Medico Julian Coronel S.A
state: Valle Del Cauca
city: Hellerup
country: Denmark
facility: Gentofte Hospital
state: Copenhagen
city: Hvidovre
country: Denmark
facility: Gastroenheden, Hvidovre hospital
state: Copenhagen
city: Karlsruhe
country: Germany
facility: Klinische Forschung Karlsruhe GmbH
state: Baden-Wuertemberg
city: Böhlen
country: Germany
facility: Studienzentrum Schwittay
state: Saxony
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
state: Saxony
city: Hamburg
country: Germany
facility: Clinical Research Hamburg
city: Hamburg
country: Germany
facility: Israelitisches Krankenhaus
city: Hannover
country: Germany
facility: KRH Klinikum Siloah
city: Szeged
country: Hungary
facility: First Department of Medicine, University of Szeged
state: CsonfrÃ¡d
city: Eger
country: Hungary
facility: Markhot Ferenc Oktatokorhaz es Rendelointezet
state: Heves
city: Tószeg
country: Hungary
facility: Hetenyi Geza Hospital
state: Jász-Nagykun-Szolnok
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz
state: Zala
city: Budapest
country: Hungary
facility: Synexus Budapest DRS
city: Budapest
country: Hungary
facility: Strázsahegy Gyógyszertár Medicina
city: Hyderabad
country: India
facility: Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre
state: Gujarat
city: Bangalore
country: India
facility: Victoria Hospital
state: Karnataka
city: Bangalore
country: India
facility: Life Care Hospital & Research Centre
state: Karnataka
city: Bengaluru
country: India
facility: Diacon Hospital and research Center - Diabetology
state: Karnataka
city: Bengaluru
country: India
facility: Rajalakshmi Hospital
state: Karnataka
city: Mangalore
country: India
facility: Vinaya Hospital & Research Centre
state: Karnataka
city: Mumbai
country: India
facility: Bhatia Hospital
state: Maharashtra
city: Pune
country: India
facility: B. J. Government Medical College and Sassoon General Hospitals
state: Maharashtra
city: Pune
country: India
facility: Universal Hospital
state: Maharashtra
city: Pune
country: India
facility: Noble Hospital
state: Maharashtra
city: Jaipur
country: India
facility: S.R. Kalla (SRK) Memorial Gastro & General Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Diabetic Thyroid and Endocrine Centre
state: Rajasthan
city: Jaipur
country: India
facility: Marudhar Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Eternal Hospital - Diabetology
state: Rajasthan
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Coimbatore
country: India
facility: Kovai Diabetes Speciality Centre
state: Tamil Nadu
city: Madurai
country: India
facility: Arthur Asirvatham Hospital
state: Tamil Nadu
city: Lucknow
country: India
facility: M. V Hospital & Research Centre
state: Uttar Prandesh
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Safed
country: Israel
facility: Endocrinology & Diabetes Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-Do
city: Seoul
country: Korea, Republic of
facility: Diabetes Center
state: Nowon-gu
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Kraslava
country: Latvia
facility: Kraslava Hospital
state: Kraslavas Nov.
city: Daugavpils
country: Latvia
facility: Polana-D
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital, Endokrinologijas nodala
city: Riga
country: Latvia
facility: Digestive Diseases Centre GASTRO
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
state: Kedah
city: Kubang Kerian
country: Malaysia
facility: Universiti Sains Malaysia
city: Taiping
country: Malaysia
facility: Hospital Taiping
city: Cuauhtemoc
country: Mexico
facility: Mentrials SA DE CV
state: Cdmx
city: Mexico
country: Mexico
facility: Clinicos Asociados BOCM SC
state: Distrito Federal
city: Mexico
country: Mexico
facility: Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology
state: Distrito Federal
city: Durango
country: Mexico
facility: Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición
state: Guillermina
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Consultorio Medico
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clínica en Medicina S.C.
state: Jalisco
city: Mexico
country: Mexico
facility: Centro de Atención e Investigación en Factores de Riesgo Car
state: Mexico DF
city: Mérida
country: Mexico
facility: Centro de Desarrollo Biomédico S.C.P
state: Yucatán
city: Aguascalientes
country: Mexico
facility: Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
city: Aguascalientes
country: Mexico
facility: Hospital Cardiologica Aguascalientes
city: Durango
country: Mexico
facility: Dioderm Instituto de Investigacion
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon, S.C.
city: IloIlo City
country: Philippines
facility: West Visayas State University Medical Center
state: IloIlo
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
state: Metro Manila
city: San Juan City
country: Philippines
facility: Cardinal Santos Medical Center
state: Metro Manila
city: Manila
country: Philippines
facility: Manila Doctors Hospital, Ermita
state: Metropolitan Manila
city: Pasay
country: Philippines
facility: San Juan De Dios Educational Foundation, Inc.
state: Metropolitan Manila
city: Makati City
country: Philippines
facility: Ospital ng Makati
state: NCR
city: Cebu City
country: Philippines
facility: Perpetual Succor Hospital
city: Bialystok
country: Poland
facility: NZOZ Vita Diabetica - Malgorzata Buraczyk
state: Podlaski
city: Sopot
country: Poland
facility: Endoskopia Sp. Z O.O.
state: Pomorskie
city: Chojnice
country: Poland
facility: Centrum Medyczne Lukamed
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Neurologiczny Marta Banach
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
city: St-Petersburg
country: Russian Federation
facility: Saint-Petersburg City Pokrovskaya Hospital
state: Leningrad Region
city: Novosibirsk
country: Russian Federation
facility: Scientific Institute of Clinical and Experimental Lymphology
state: Novosibirskaya Oblast
city: Saint-Petersburg
country: Russian Federation
facility: North-Western State Medical University named after I. I. Mechnikov
state: Sankt-Peterburg
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko
state: Volga
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Moscow
country: Russian Federation
facility: FSBI National medical endocrinology research centre
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinical Institute named by MF Vladimirski
city: Rostov on Don
country: Russian Federation
facility: Rostov on Don
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saratov
country: Russian Federation
facility: GUZ Saratov City Clinical Hospital 9
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital 12
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Bloemfontein
country: South Africa
facility: FARMOVS
state: Free State
city: Johannesburg
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Synexus Stanza Clincal Reaserch Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Watermeyer Clinical Research Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Synexus Helderberg Clinical Research Centre
state: Western Cape
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol University
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk National Medical University
state: Ivano-Frankivsk Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Central City Clinical Hospital
state: Ivano-Frankivsk Oblast
city: Chernivtsi
country: Ukraine
facility: Regional muniRegional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious
city: Chernivtsi
country: Ukraine
facility: Regional Public Organization "Chernivtsi Regional Endocrinology Center"
city: Dnipro
country: Ukraine
facility: State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
city: Kharkiv
country: Ukraine
facility: Municipal nonprofit entity of Kharkiv municipal council
city: Kharkiv
country: Ukraine
facility: L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine
city: Kharkiv
country: Ukraine
facility: Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
city: Kherson
country: Ukraine
facility: Communal Institution Kherson City Clinical Hospital
city: Kyiv
country: Ukraine
facility: Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
city: Kyiv
country: Ukraine
facility: Kyiv clinical hospital on railway transport #2 of the "Healthcare Centre" branch of JSC "Ukrainian Railway"
city: Kyiv
country: Ukraine
facility: Medical Center Universal Clinic Oberig
city: Kyiv
country: Ukraine
facility: Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
city: Odesa
country: Ukraine
facility: Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
city: Odesa
country: Ukraine
facility: Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital
city: Vinnytsia
country: Ukraine
facility: Private Small-Scale Enterprise Medical Centre Pulse
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical highly specialized Endocrinology Centre
city: Vinnytsia
country: Ukraine
facility: Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia
city: Zaporizhzhia
country: Ukraine
facility: 6th City Clinical Hospital, c. Zaporizhzhia
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution, City Hospital #7
city: Nottingham
country: United Kingdom
facility: Biomedical Research Centre
state: East Midland
city: Manchester
country: United Kingdom
facility: MAC Clinical Research Manchester
state: Greater Manchester
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
state: Lancashire
city: Cannock
country: United Kingdom
facility: MAC Research, Exchange House
state: Staffordshire
city: Leeds
country: United Kingdom
facility: MAC Clinical Research, Monarch House
state: West Yorkshire
city: Barnsley
country: United Kingdom
facility: MAC Research
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research, Kaman Court
city: Chelmsford
country: United Kingdom
facility: Mid Essex Hospital Services NHS Trust Broomfield Hospital
city: Liverpool
country: United Kingdom
facility: MAC Clinical Research
city: Stockton-on-Tees
country: United Kingdom
facility: MAC Clinical Research, GAC House
Study officials:
affiliation: Allergan
name: Wieslaw Bochenek
role: STUDY_DIRECTOR
References: