Clinical trial NCT03383146: A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
Official title: A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study 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: 2017-12-26
Enrollment: 450
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 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.


Eligibility criteria: Inclusion Criteria:

Two different groups of participants may enter into the study:

1. Rollover Participants

   Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply:

   •In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that:
   * They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR
   * They had vomiting episodes and an average daily DGSSS of ≥12 but \<16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device
2. De Novo Participants

   * Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11%
   * DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
   * Compliance with the entry of data into the hand-held electronic device during the Run-in Period
   * Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period
   * The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12

Exclusion Criteria:

1. Both Rollover and De Novo Participants

   •Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
2. Rollover Participants

   •Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at the Screening Visit and at the end of the Run-in Period for randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria
3. De Novo Participants

   * History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the Screening Visit
   * History of intestinal malabsorption or pancreatic exocrine insufficiency
   * History of belching disorders, other nausea and vomiting disorders
   * Gastric or duodenal ulcer within 3 months of Screening
   * History of malignancy in the 3 years prior to Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
   * Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
   * Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g., erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI promotility agents for at least 10 days prior to the start of the Run-in Period
   * Currently taking opiates, or expecting to use opiates during the course of the clinical study
   * Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period
   * History of pyloric injection of botulinum toxin within 6 months of screening
   * History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)
   * Randomization in any previous study in which relamorelin was a treatment
   * Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the gastric emptying breath test (GEBT) study meal

Primary outcomes:
measure: Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study
measure: Change From Baseline to Week 52 in the Weekly Average DGSSS
timeFrame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study
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 56 weeks)
measure: Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
timeFrame: Up to 52 weeks
measure: Number of Participants With Clinically Meaningful Trends for Vital Signs
timeFrame: Up to 52 weeks
measure: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
timeFrame: Up to 52 weeks
measure: Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c)
timeFrame: Up to 52 weeks
measure: Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
timeFrame: Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Athens
country: United States
facility: North Alabama Research Center, LLC
state: Alabama
city: Birmingham
country: United States
facility: Simon Williamson Clinic
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: Huntsville
country: United States
facility: Avant Research Associates
state: Alabama
city: Mobile
country: United States
facility: Alabama Medical Group, PC
state: Alabama
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: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Tucson
country: United States
facility: Synexus Clinical Research US, Inc.
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: El Cajon
country: United States
facility: TriWest Research Associates
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: Palo Alto
country: United States
facility: Stanford Hospital
state: California
city: San Diego
country: United States
facility: Optimal Research California
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: Vista
country: United States
facility: Synexus Clinical Research US, Inc.
state: California
city: Whittier
country: United States
facility: New Hope Research Development
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Synexus
state: Colorado
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County, P.C.
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Innovative Research of West FL, Inc.
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: 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: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare
state: Florida
city: Pinellas Park
country: United States
facility: Synexus
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
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: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
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: Evansville
country: United States
facility: Synexus Clinical Research US, Inc.
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: Erlanger
country: United States
facility: St. Elizabeth Healthcare â€" Clinical Research Institute
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
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: West Monroe
country: United States
facility: Clinical Trials of America, Inc.
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
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: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Rockville
country: United States
facility: Meridian Clinical Research, LLC
state: Maryland
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, West Michigan Clinical Research Center
state: Michigan
city: Coon Rapids
country: United States
facility: MNGI Digestive Health
state: Minnesota
city: Richfield
country: United States
facility: Synexus Clinical Research US, Inc.
state: Minnesota
city: Saint Louis
country: United States
facility: Synexus Clinical Research US, Inc
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Omaha
country: United States
facility: Diabetes and Endocrine Associates, P.C.
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 - CROSN
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 LLC
state: New Jersey
city: Bridgeton
country: United States
facility: Synexus Clinical Research US, Inc.
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: Bronx
country: United States
facility: CHEAR Center LLC
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group LLP
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: Charlotte
country: United States
facility: Carolinas Healthcare-Charlotte
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: Akron
country: United States
facility: Synexus Clinical Research US, Inc.
state: Ohio
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: Cincinnati
country: United States
facility: Synexus Clinical Research US, Inc
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.
state: Ohio
city: Oklahoma City
country: United States
facility: Centennial Health-Synexus
state: Oklahoma
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: Sayre
country: United States
facility: Guthrie Clinical Research
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
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: Clinton
country: United States
facility: Carolina Medical Research
state: South Carolina
city: Greenville
country: United States
facility: Gastroenterology Associates, PA
state: South Carolina
city: Greer
country: United States
facility: Synexus Clinical Research
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: Gastroenterology Centers of the Midsouth
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee Research Institute
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: Beaumont
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Carrollton
country: United States
facility: ClinRx Research, LLC
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Medical Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc., Research Center
state: Texas
city: Houston
country: United States
facility: Houston Endoscopy and Research Center, Inc.
state: Texas
city: Houston
country: United States
facility: Rodriguez Clinical Trials
state: Texas
city: Houston
country: United States
facility: Amir 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: Sagact Pllc.
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research US, Inc.
state: Texas
city: Layton
country: United States
facility: Synexus Clinical Research US, Inc.
state: Utah
city: Murray
country: United States
facility: Synexus Clinical Research US, Inc.
state: Utah
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: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Centre
state: Virginia
city: Richmond
country: United States
facility: VA Medical Center McGuire VAMC
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: Buenos Aires
country: Argentina
facility: Consultorios Asociados de Endocrinologia e InvestigaciÃ³n Cl
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 SRL
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autonoma deBuenos Aires
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas de Rosario
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Medico Catamarca-I.ME.C
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
state: Tucuman
city: Cordoba
country: Argentina
facility: CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian
city: Corrientes
country: Argentina
facility: Centro Universitario de Investigacion en Farmacologia Clinic
city: Córdoba
country: Argentina
facility: Instituto Privado de Investigaciones Clinicas de Cordoba
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Osterreicher
country: Austria
facility: Ordination
state: Steiermark
city: Feldkirch
country: Austria
facility: VIVIT Institute, am LKH Feldkirch
state: Vorarlberg
city: Salzburg
country: Austria
facility: Privatklinik wehlre-Diakonissen
city: Steyr
country: Austria
facility: Oö. Gesundheits- und Spitals-AG/LKH 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: CE
city: Brasilia
country: Brazil
facility: Centro de Pesquisa Clinica do Brasil
state: Distrito Federal
city: Belem
country: Brazil
facility: Hospital Universitário João de Barros Barreto - UFPA
state: PA
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 Clínica Ltda
state: Sao Paulo
city: Campinas
country: Brazil
facility: Instituto de Pesquisa Clinica em Campinas
state: Sao Paulo
city: Fortaleza
country: Brazil
facility: Instituto de Estudos e Pesquisas Clinicas do Ceara IEP/CE - Oncology
city: Sao Paulo
country: Brazil
facility: IPEC-Instituto de Pesquisa Clinica
city: Sao Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica Ltda
city: Byala
country: Bulgaria
facility: MHAT Yuliya Vrevska Byala
state: Ruse
city: Plovdiv
country: Bulgaria
facility: UMHAT - Kaspela- EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Asklepion - Humane Medicine Research EOOD
city: Sofia
country: Bulgaria
facility: Alexandrovska University Hospital
city: Calgary
country: Canada
facility: University of Calgary
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: St. John's
country: Canada
facility: Patient research centre
state: Newfoundland and Labrador
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, Inc.
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: Fundación del Caribe para la InvestigacionBiomédica-Fundación BIOS
state: Atlantico
city: Bogotá
country: Colombia
facility: Asociación Colombiana de Diabetes
state: Cundinamarca
city: Zipaquira
country: Colombia
facility: Healthy Medical Center
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Endocare Ltda.
state: Distrito Capital De Bogotá
city: Bogotá
country: Colombia
facility: Medplus Centro de Recuperacion Integral S.A.S.
state: Distrito Capital
city: Pereira
country: Colombia
facility: Centro de Investigaciones Clínicas IPS CARDIOMET Pereira
state: Risaralda
city: Cali
country: Colombia
facility: IPS Centro Medico Julian Coronel S.A
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A.
state: Valle Del Cauca
city: Hellerup
country: Denmark
facility: Steno Diabetes Center Copenhagen
state: Copenhagen
city: Hvidovre
country: Denmark
facility: Gastroenheden, Hvidovre hospital
state: København
city: Karlsruhe
country: Germany
facility: Klinische Forschung Karlsruhe GmbH
state: Baden-Wurttemberg
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: Eger
country: Hungary
facility: Markhot Ferenc Oktatokorhaz es Rendelointezet
state: Heves
city: Szolnok
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: Strázsahegy Gyógyszertár Medicina
city: Szeged
country: Hungary
facility: Szegedi TudomanyegyetemSzent-Gyorgyi Albert Klinikai Kozpont és Altalanos Orvostudomanyi Kar Belgyogyaszati Klinika
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 - Gasterentrology
state: Gujarat
city: Ahmedabad
country: India
facility: Zydus Hospital
state: Gujarat
city: Bangalore
country: India
facility: Lifecare Clinic and Research Centre - Internal Med/Diabetology
state: Karnataka
city: Bengaluru
country: India
facility: Diacon Hospital and research Center - Diabetology
state: Karnataka
city: Bengaluru
country: India
facility: Victoria Hospital Bangalore Medical College and Research Institute
state: Karnataka
city: Bengaluru
country: India
facility: Rajalakshmi Hospital
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: Marudhar Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Eternal Hospital - Diabetology
state: Rajasthan
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Chennai
country: India
facility: M.V. Hospital for Diabetes & Diabetes Research Centre
state: Tamil Nadu
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 Pradesh
city: Delhi
country: India
facility: Sir Ganga Ram Hospital (SGRH)
city: Mangalore
country: India
facility: Vinaya Hospital & Research Centre
city: Haifa
country: Israel
facility: Bnei-Zion MC
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-Do
city: Seoul
country: Korea, Republic of
facility: Sanggye Paik Hospital, Inje University College of Medicine
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: Kuala Lumpur
country: Malaysia
facility: Clinical Investigation Centre
city: Kubang Kerian
country: Malaysia
facility: Clinical Trial Unit, School of Medical Sciences, Health Campus, Hospital Universiti Sains Malaysia
city: Taiping
country: Malaysia
facility: Hospital Taiping
city: Mexico DF
country: Mexico
facility: Mentrials Sa de Cv
state: Distrito Federal
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: Mexico
country: Mexico
facility: Centro de Atención e Investigación en Factores de Riesgo Car
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente
state: Jalisco
city: Guadalajara
country: Mexico
facility: Consultorio particular
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clínica en Medicina S.C/
state: Jalisco
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: Durango
country: Mexico
facility: CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)
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: 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: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Kraków
country: Poland
facility: Specjalistyczny Gabinet Neurologiczny Marta Banach
state: Lesser Poland
city: Krakow
country: Poland
facility: CenterMed Krakow Ltd
state: Malopolska
city: Chojnice
country: Poland
facility: Centrum Medyczne Lukamed
city: St-Petersburg
country: Russian Federation
facility: Saint-Petersburg City Pokrovskaya Hospital
state: Leningrad Region
city: Saratov
country: Russian Federation
facility: GUZ Saratov City Clinical Hospital 9
state: Saratov Region
city: Novosibirsk
country: Russian Federation
facility: Scientific Institute of Clinical and Experimental Lymphology
city: Rostov on Don
country: Russian Federation
facility: Rostov on Don
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Singapore 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 Clinical Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Watermeyer Clinical Research Site
state: Val De Grace
city: Somerset West
country: South Africa
facility: Synexus Helderberg Clinical Research Centre
city: Madrid
country: Spain
facility: Hospital Universitario Principe de Asturias
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: Dnipro
country: Ukraine
facility: State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
state: Dnipropetrovs'ka Oblast'
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution, City Hospital #7, polyclinic department, c. Zaporizhzhia
state: Zaporizhzhia Region
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Clinical Hospital
city: Chernivtsi
country: Ukraine
facility: Regional Municipal noncommercial Enterprise "Chernivtsi Regional Endocrinology Center", Polyclinic department, Higher State Educational Establishment of Ukraine "Bukovinian State Medical University", Department of Clinical Immunology, Allergology and Endo
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk National Medical University
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Central City Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Municipal nonprofit entity of Kharkiv municipal council
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: Kyiv Railway Clinical Hospital No-2 of Branch of Healthcare Center of the PJSC Ukrainian Railway , Endocrynology Department
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: Poltava
country: Ukraine
facility: Poltava Regional Clinical 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: Zaporizhzhia
country: Ukraine
facility: Municipal Institution 6th City Clinical Hospital, Dept of Gastroenterology
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: Liverpool
country: United Kingdom
facility: MAC Clinical Research
state: Merseyside
city: Cannock
country: United Kingdom
facility: MAC Research, Exchange House
state: Staffordshire
city: Stoke on Trent
country: United Kingdom
facility: University Hospitals of North Midlands
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: Manchester
country: United Kingdom
facility: MAC Clinical Research, GAC House
Study officials:
affiliation: Allergan
name: Harvy Schneier
role: STUDY_DIRECTOR
References: