A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

NCT ID: NCT03420781

Last Updated: 2021-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

467 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-24

Study Completion Date

2020-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroparesis Diabetes Mellitus

Keywords

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diabetic gastroparesis vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment Period: Placebo

Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo injected twice daily

Treatment Period: Relamorelin 10 μg

Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.

Group Type EXPERIMENTAL

Relamorelin

Intervention Type DRUG

Relamorelin 10 μg injected twice daily

Randomized Withdrawal Period: Placebo then Relamorelin 10 μg

Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo injected twice daily

Relamorelin

Intervention Type DRUG

Relamorelin 10 μg injected twice daily

Randomized Withdrawal Period: Relamorelin 10 μg then Relamorelin 10 μg

Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.

Group Type EXPERIMENTAL

Relamorelin

Intervention Type DRUG

Relamorelin 10 μg injected twice daily

Randomized Withdrawal Period: Relamorelin 10 μg then Placebo

Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo injected twice daily

Relamorelin

Intervention Type DRUG

Relamorelin 10 μg injected twice daily

Interventions

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Placebo

Placebo injected twice daily

Intervention Type DRUG

Relamorelin

Relamorelin 10 μg injected twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants are eligible to be included in the study only if all the following criteria apply:

Exclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wieslaw Bochenek

Role: STUDY_DIRECTOR

Allergan

Locations

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North Alabama Research Center, LLC

Athens, Alabama, United States

Site Status

Digestive Health Specialist of the South East

Dothan, Alabama, United States

Site Status

G & L Research, LLC

Foley, Alabama, United States

Site Status

Alabama Medical Group, PC

Mobile, Alabama, United States

Site Status

Del Sol Research Management, LLC

Chandler, Arizona, United States

Site Status

Phoenix Clinical LLC.

Phoenix, Arizona, United States

Site Status

Del Sol Research Management, LLC

Tucson, Arizona, United States

Site Status

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Site Status

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Site Status

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Site Status

Unity Health - Searcy Medical Center

Searcy, Arkansas, United States

Site Status

Hope Clinical Research

Canoga Park, California, United States

Site Status

GW Research Inc

Chula Vista, California, United States

Site Status

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, United States

Site Status

Aurora Care Clinic, LLC

Costa Mesa, California, United States

Site Status

Diagnamics Inc.

Encinitas, California, United States

Site Status

VVCRD Research

Garden Grove, California, United States

Site Status

University of California San Diego

La Jolla, California, United States

Site Status

Om Research LLC

Lancaster, California, United States

Site Status

Torrance Clinical Research Institute, Inc.

Lomita, California, United States

Site Status

Angel City Research Inc.

Los Angeles, California, United States

Site Status

TriWest Research Associates

Poway, California, United States

Site Status

Medical Associates Research Group, Inc

San Diego, California, United States

Site Status

Syrentis Clinical Research

Santa Ana, California, United States

Site Status

Upland Clinical Research

Upland, California, United States

Site Status

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Site Status

Synexus Clinical Research US, Inc. - Colorado Springs Family Practice

Colorado Springs, Colorado, United States

Site Status

Gastroenterology Associates of Fairfield County, P.C.

Bridgeport, Connecticut, United States

Site Status

TrialSpark, Inc.

Washington D.C., District of Columbia, United States

Site Status

Innovative Research of West FL, Inc.

Clearwater, Florida, United States

Site Status

West Central Gastroenterology

Clearwater, Florida, United States

Site Status

Clinical Research of West Florida

Clearwater, Florida, United States

Site Status

ALL Medical Research LLC

Cooper City, Florida, United States

Site Status

Top Medical Research

Cutler Bay, Florida, United States

Site Status

Palmetto Research, LLC

Hialeah, Florida, United States

Site Status

Vida Clinical Trials

Homestead, Florida, United States

Site Status

Nature Coast Clinical Research

Inverness, Florida, United States

Site Status

APF Research LLC

Miami, Florida, United States

Site Status

AMPM Research Clinic

Miami, Florida, United States

Site Status

Advanced Medical Research Institute

Miami, Florida, United States

Site Status

Florida Research Center, Inc.

Miami, Florida, United States

Site Status

American Research Institute, Inc

Miami, Florida, United States

Site Status

Panax Clinical Research, LLC.

Miami Lakes, Florida, United States

Site Status

Savin Medical Group LLC

Miami Lakes, Florida, United States

Site Status

Synexus

Pinellas Park, Florida, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

River Birch Research Alliance, LLC

Blue Ridge, Georgia, United States

Site Status

Gwinnett Research Institute, LLC

Buford, Georgia, United States

Site Status

Summit Clinical Research, LLC.

Carnesville, Georgia, United States

Site Status

iResearch Atlanta LLC

Decatur, Georgia, United States

Site Status

Infinite Clinical Trials

Riverdale, Georgia, United States

Site Status

Clinical Research Consultants of Atlanta

Suwanee, Georgia, United States

Site Status

Rocky Mountain Diabetes and Osteoporosis Center, PA

Idaho Falls, Idaho, United States

Site Status

Southwest Gastroenterology

Oak Lawn, Illinois, United States

Site Status

MediSphere Medical Research Center, LLC

Evansville, Indiana, United States

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American Research, LLC

Jeffersonville, Indiana, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Health Science Research Center

Pratt, Kansas, United States

Site Status

WestGlen Gastrointestinal Consultants

Shawnee Mission, Kansas, United States

Site Status

Cotton-O'Neil Clinical Research Center - Digestive Health

Topeka, Kansas, United States

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Kansas Medical Clinic

Topeka, Kansas, United States

Site Status

Professional Research Network of Kansas, LLC

Wichita, Kansas, United States

Site Status

Via Christi Clinic, PA

Wichita, Kansas, United States

Site Status

Tri-State Gastroenterology

Crestview Hills, Kentucky, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

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Delta Research Partners

Bastrop, Louisiana, United States

Site Status

WK Physicians Network

Bossier City, Louisiana, United States

Site Status

Avant Research Associates LLC

Crowley, Louisiana, United States

Site Status

Cronola LLC

Houma, Louisiana, United States

Site Status

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, United States

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Tandem Clinical Research

Marrero, Louisiana, United States

Site Status

New Orleans Research Institute - Metropolitan Gastroenterology Associates

Metairie, Louisiana, United States

Site Status

Clinical Trials of America, Inc.

West Monroe, Louisiana, United States

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Trialspark - Silverman

Bowie, Maryland, United States

Site Status

Gastro Center of Maryland

Columbia, Maryland, United States

Site Status

Frederick Gastroenterology Associates, PA an Elligo Health Research Site

Frederick, Maryland, United States

Site Status

Woodholme Gastroenterology Associates, P.A.

Glen Burnie, Maryland, United States

Site Status

Meridian Clinical Research, LLC

Rockville, Maryland, United States

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Commonwealth Clinical Studies, PLLC.

Brockton, Massachusetts, United States

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Clinical Research Institute of Michigan

Chesterfield, Michigan, United States

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Vida Clinical Studies

Dearborn, Michigan, United States

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Aa Mrc Llc

Flint, Michigan, United States

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National Clinical, LLC

Hamtramck, Michigan, United States

Site Status

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, United States

Site Status

Minnesota Gastroenterology, P.A.

Coon Rapids, Minnesota, United States

Site Status

Montana Medical Research

Missoula, Montana, United States

Site Status

Methodist Physicians Clinic Diabetes and Endocrine Specialists

Omaha, Nebraska, United States

Site Status

Heartland Clinical Research, Inc

Omaha, Nebraska, United States

Site Status

Excel Clinical Research

Las Vegas, Nevada, United States

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Clinical Research of South Nevada

Las Vegas, Nevada, United States

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Advanced Biomedical Research of America

Las Vegas, Nevada, United States

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Digestive Disease Specialists

Las Vegas, Nevada, United States

Site Status

Palm Research Center

Las Vegas, Nevada, United States

Site Status

Garden State Endocrinology

Brick, New Jersey, United States

Site Status

AGA Clinical Research Associates LLC

Egg Harbor, New Jersey, United States

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Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, United States

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Long Island Gastrointestinal Research Group LLP

Great Neck, New York, United States

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Synexus Clinical Research US, Inc.

Jamaica, New York, United States

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United Health Services Hospitals, Inc.

Johnson City, New York, United States

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Asheville Gastroenterology Associates

Asheville, North Carolina, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Carolina Digestive Health Associates, PA

Concord, North Carolina, United States

Site Status

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Site Status

Triad Clinical Trials

Greensboro, North Carolina, United States

Site Status

Vidant Multispeciality Clinic - Kinston

Kinston, North Carolina, United States

Site Status

Diabetes and Endocrinology Consultants, PC

Morehead City, North Carolina, United States

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PMG Research Salisbury

Salisbury, North Carolina, United States

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PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

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Trial Management Associates, LLC

Wilmington, North Carolina, United States

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PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

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The Center for Clinical Research

Winston-Salem, North Carolina, United States

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Dayton Gastroenterology, Inc.

Beavercreek, Ohio, United States

Site Status

Diabetes & Endocrinology Associates of Stark County, Inc.

Canton, Ohio, United States

Site Status

Synexus Clinical Research US - Cincinnati

Cincinnati, Ohio, United States

Site Status

Endocrinology Research Associates, Inc.

Columbus, Ohio, United States

Site Status

The Ohio State University, Wexner Medical Center

Columbus, Ohio, United States

Site Status

Aventiv Research, Inc.

Columbus, Ohio, United States

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Hometown Urgent Care and Research

Columbus, Ohio, United States

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CIC America Clinical Inquest Center Ltd.

Dayton, Ohio, United States

Site Status

Hometown Urgent Care and Research

Dayton, Ohio, United States

Site Status

Premier Clinical Research d.b.a. STAT Research

Franklin, Ohio, United States

Site Status

Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research

Wadsworth, Ohio, United States

Site Status

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, United States

Site Status

Memorial Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Options Health Research, LLC

Tulsa, Oklahoma, United States

Site Status

Northwest Gastroenterology Clinic, LLC

Portland, Oregon, United States

Site Status

Family Medical Associates, Research Department

Levittown, Pennsylvania, United States

Site Status

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, United States

Site Status

Preferred Primary Care Physicians, Inc.

Pittsburgh, Pennsylvania, United States

Site Status

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, United States

Site Status

Montgomery Medical, Inc.

Smithfield, Pennsylvania, United States

Site Status

Preferred Primary Care Physicians

Uniontown, Pennsylvania, United States

Site Status

Synexus Clinical Research US, Inc.

Anderson, South Carolina, United States

Site Status

Synexus Clinical Research US, Inc

Anderson, South Carolina, United States

Site Status

Clinical Trials of South Carolina

Charleston, South Carolina, United States

Site Status

Gastroenterology Associates, PA

Greenville, South Carolina, United States

Site Status

Health Concepts

Rapid City, South Dakota, United States

Site Status

Clinsearch

Chattanooga, Tennessee, United States

Site Status

Gastro One

Germantown, Tennessee, United States

Site Status

Quality Medical Research

Nashville, Tennessee, United States

Site Status

Texas Clinical Research Institute, LLC

Arlington, Texas, United States

Site Status

Avant Research Associates,LLC

Austin, Texas, United States

Site Status

ClinRx Research, LLC

Carrollton, Texas, United States

Site Status

Synexus Clinical Research US, Inc.

Dallas, Texas, United States

Site Status

Biopharma Informatic Inc., Research Center

Houston, Texas, United States

Site Status

Rodriguez Clinical Trials

Houston, Texas, United States

Site Status

Amir Ali Hassan, MD, PA

Houston, Texas, United States

Site Status

Sante Clinical Research

Kerrville, Texas, United States

Site Status

Pinnacle Clinical Research

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

Southern Star Research Institute, LLC

San Antonio, Texas, United States

Site Status

Synexus Clinical Research US, Inc.

San Antonio, Texas, United States

Site Status

Advanced Research Institute, Inc.

Ogden, Utah, United States

Site Status

Advanced Clinical Research

West Jordan, Utah, United States

Site Status

Verity Research Inc.

Fairfax, Virginia, United States

Site Status

Manassas Clinical Research Centre

Manassas, Virginia, United States

Site Status

Cardinal Internal Medicine Associates, PC

Woodbridge, Virginia, United States

Site Status

Washington Gastroenterology PLLC

Tacoma, Washington, United States

Site Status

West Virginia University

Morgantown, West Virginia, United States

Site Status

Maffei Centro Medico-Investigacion Clinica Aplicada

C.a.b.a., Buenos Aires, Argentina

Site Status

Hospital Sirio Libanes

CABA, Buenos Aires, Argentina

Site Status

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

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Instituto Privado de Investigaciones Clínicas de Córdoba

Córdoba, Córdoba Province, Argentina

Site Status

Instituto de Investigaciones Clinicas de Rosario

Rosario, Santa Fe Province, Argentina

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Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli

Rosario, Santa Fe Province, Argentina

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Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

San Miguel de Tucumán, Tucumán Province, Argentina

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CIPREC

Buenos Aires, , Argentina

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Centro Universitario de Investigacion en Farmacologia Clinic

Corrientes, , Argentina

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Nepean Hospital

Kingswood, New South Wales, Australia

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Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

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Ordination

Sankt Stefan ob Stainz, Styria, Austria

Site Status

VIVIT Institute, am LKH Feldkirch

Feldkirch, Vorarlberg, Austria

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Privatklinik Wehrle-Diakonissen

Salzburg, , Austria

Site Status

Landeskrankenhaus Steyr

Steyr, , Austria

Site Status

Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

Edegem, Antwerp, Belgium

Site Status

UZ Brussel

Jette, Brussels Capital, Belgium

Site Status

AZ Sint Lucas Brugge

Bruges, West-Vlaanderen, Belgium

Site Status

Instituto de Estudos e Pesquisas Clinicas do Ceará IEP/CE - Oncology

Fortaleza, Ceará, Brazil

Site Status

Hospital Universitário Walter Cantídio

Fortaleza, Ceará, Brazil

Site Status

Centro de Pesquisa Clinica do Brasil

Brasília, Federal District, Brazil

Site Status

Núcleo de Pesquisa Clínica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto Catarinense de Endocrinologia e Diabetes (ICED)

Joinville, Santa Catarina, Brazil

Site Status

Scentryphar Pesquisa Clinica Ltda

Campinas, São Paulo, Brazil

Site Status

Instituto de Pesquisa Clinica de Campinas

Campinas, São Paulo, Brazil

Site Status

CPQuali Pesquisa Clinica Ltda

Santa Cecília, São Paulo, Brazil

Site Status

Hospital Universitário João de Barros Barreto

Belém, , Brazil

Site Status

IPEC-Instituto de Pesquisa Clinica

São Paulo, , Brazil

Site Status

MHAT Yuliya Vrevska Byala

Byala, Ruse, Bulgaria

Site Status

UMHAT - Kaspela- EOOD

Plovdiv, , Bulgaria

Site Status

University of Calgary

Calgary, Alberta, Canada

Site Status

Alberta Diabetes Institute

Edmonton, Alberta, Canada

Site Status

Central Alberta Research Centre

Red Deer, Alberta, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

South Shore Medical Arts

Bridgewater, Nova Scotia, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Toronto Digestive Disease Associates

Vaughan, Ontario, Canada

Site Status

Recherche GCP Research

Montreal, Quebec, Canada

Site Status

Rodrigo Botero S.A.S.

Medellín, Antioquia, Colombia

Site Status

Centro Cardiovascular Colombiano Clínica Santa María

Medellín, Antioquia, Colombia

Site Status

Centro Cardiovascular y de Diabetes

Barranquilla, Atlántico, Colombia

Site Status

Fundacion BIOS

Barranquilla, Atlántico, Colombia

Site Status

Medplus Medicina Prepagada

Bogotá, Bogota D.C., Colombia

Site Status

Asociación Colombiana de Diabetes

Teusaquillo, Bogota D.C., Colombia

Site Status

Endocare Ltda.

Bogotá, Cundinamarca, Colombia

Site Status

Healthy Medical Center

Zipaquirá, Cundinamarca, Colombia

Site Status

Fundacion Centro de Investigaciones Clinicas CARDIOMET

Pereira, Risaralda Department, Colombia

Site Status

Centro Medico Imbanaco de Cali S.A.

Cali, Valle del Cauca Department, Colombia

Site Status

IPS Centro Medico Julian Coronel S.A

Cali, Valle del Cauca Department, Colombia

Site Status

Gentofte Hospital

Hellerup, Copenhagen, Denmark

Site Status

Gastroenheden, Hvidovre hospital

Hvidovre, Copenhagen, Denmark

Site Status

Klinische Forschung Karlsruhe GmbH

Karlsruhe, Baden-Wurttemberg, Germany

Site Status

Studienzentrum Schwittay

Böhlen, Saxony, Germany

Site Status

Klinische Forschung Dresden GmbH

Dresden, Saxony, Germany

Site Status

Clinical Research Hamburg

Hamburg, , Germany

Site Status

Israelitisches Krankenhaus

Hamburg, , Germany

Site Status

KRH Klinikum Siloah

Hanover, , Germany

Site Status

First Department of Medicine, University of Szeged

Szeged, Csonfrád, Hungary

Site Status

Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, Heves County, Hungary

Site Status

Hetenyi Geza Hospital

Tószeg, Jász-Nagykun-Szolnok, Hungary

Site Status

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, Zala County, Hungary

Site Status

Synexus Budapest DRS

Budapest, , Hungary

Site Status

Strázsahegy Gyógyszertár Medicina

Budapest, , Hungary

Site Status

Kumudini Devi Diabetes Research Center; Ramdevrao Hospital

Hyderabad, Andhra Pradesh, India

Site Status

King George Hospital

Visakhapatnam, Andhra Pradesh, India

Site Status

Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre

Ahmedabad, Gujarat, India

Site Status

Victoria Hospital

Bangalore, Karnataka, India

Site Status

Life Care Hospital & Research Centre

Bangalore, Karnataka, India

Site Status

Diacon Hospital and research Center - Diabetology

Bengaluru, Karnataka, India

Site Status

Rajalakshmi Hospital

Bengaluru, Karnataka, India

Site Status

Vinaya Hospital & Research Centre

Mangalore, Karnataka, India

Site Status

Bhatia Hospital

Mumbai, Maharashtra, India

Site Status

B. J. Government Medical College and Sassoon General Hospitals

Pune, Maharashtra, India

Site Status

Universal Hospital

Pune, Maharashtra, India

Site Status

Noble Hospital

Pune, Maharashtra, India

Site Status

S.R. Kalla (SRK) Memorial Gastro & General Hospital

Jaipur, Rajasthan, India

Site Status

Diabetic Thyroid and Endocrine Centre

Jaipur, Rajasthan, India

Site Status

Marudhar Hospital

Jaipur, Rajasthan, India

Site Status

Eternal Hospital - Diabetology

Jaipur, Rajasthan, India

Site Status

SMS Hospital

Jaipur, Rajasthan, India

Site Status

Kovai Diabetes Speciality Centre

Coimbatore, Tamil Nadu, India

Site Status

Arthur Asirvatham Hospital

Madurai, Tamil Nadu, India

Site Status

M. V Hospital & Research Centre

Lucknow, Uttar Prandesh, India

Site Status

Sir Ganga Ram Hospital

New Delhi, , India

Site Status

Bnai Zion Medical Center

Haifa, , Israel

Site Status

Endocrinology & Diabetes Center

Safed, , Israel

Site Status

Kraslava Hospital

Krāslava, Kraslavas Nov., Latvia

Site Status

Polana-D

Daugavpils, , Latvia

Site Status

Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

Riga, , Latvia

Site Status

Digestive Diseases Centre GASTRO

Riga, , Latvia

Site Status

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Site Status

Universiti Sains Malaysia

Kubang Kerian, , Malaysia

Site Status

Hospital Taiping

Taiping, , Malaysia

Site Status

Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición

Durango, Guillermina, Mexico

Site Status

Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.

Guadalajara, Jalisco, Mexico

Site Status

Consultorio Medico

Guadalajara, Jalisco, Mexico

Site Status

Unidad de Investigación Clínica en Medicina S.C.

Guadalajara, Jalisco, Mexico

Site Status

Mentrials SA DE CV

Cuauhtémoc, Mexico City, Mexico

Site Status

Clinicos Asociados BOCM SC

Mexico City, Mexico City, Mexico

Site Status

Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology

Mexico City, Mexico City, Mexico

Site Status

Centro de Atención e Investigación en Factores de Riesgo Car

México, Mexico DF, Mexico

Site Status

Centro de Desarrollo Biomédico S.C.P

Mérida, Yucatán, Mexico

Site Status

Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

Aguascalientes, , Mexico

Site Status

Hospital Cardiologica Aguascalientes

Aguascalientes, , Mexico

Site Status

Dioderm Instituto de Investigacion

Durango, , Mexico

Site Status

Sociedad de Metabolismo y Corazon, S.C.

Veracruz, , Mexico

Site Status

West Visayas State University Medical Center

Iloilo City, IloIlo, Philippines

Site Status

Manila Doctors Hospital, Ermita

Manila, Metropolitan Manila, Philippines

Site Status

San Juan De Dios Educational Foundation, Inc.

Pasay, Metropolitan Manila, Philippines

Site Status

St. Luke's Medical Center

Quezon City, National Capital Region, Philippines

Site Status

Cardinal Santos Medical Center

San Juan City, National Capital Region, Philippines

Site Status

Ospital ng Makati

Makati City, NCR, Philippines

Site Status

Perpetual Succor Hospital

Cebu City, , Philippines

Site Status

NZOZ Vita Diabetica - Malgorzata Buraczyk

Bialystok, Podlaski, Poland

Site Status

Endoskopia Sp. Z O.O.

Sopot, Pomeranian Voivodeship, Poland

Site Status

Centrum Medyczne Lukamed

Chojnice, , Poland

Site Status

Specjalistyczny Gabinet Neurologiczny Marta Banach

Krakow, , Poland

Site Status

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, , Poland

Site Status

Saint-Petersburg City Pokrovskaya Hospital

St-Petersburg, Leningradskaya Oblast', Russia

Site Status

Scientific Institute of Clinical and Experimental Lymphology

Novosibirsk, Novosibirsk Oblast, Russia

Site Status

North-Western State Medical University named after I. I. Mechnikov

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko

Nizhny Novgorod, Volga, Russia

Site Status

Kazan State Medical University

Kazan', , Russia

Site Status

FSBI National medical endocrinology research centre

Moscow, , Russia

Site Status

Moscow Regional Research Clinical Institute named by MF Vladimirski

Moscow, , Russia

Site Status

Rostov on Don

Rostov-on-Don, , Russia

Site Status

Rostov State Medical University

Rostov-on-Don, , Russia

Site Status

GUZ Saratov City Clinical Hospital 9

Saratov, , Russia

Site Status

Saratov City Clinical Hospital 12

Saratov, , Russia

Site Status

National University Hospital

Singapore, , Singapore

Site Status

Singapore General Hospital

Singapore, , Singapore

Site Status

Changi General Hospital

Singapore, , Singapore

Site Status

FARMOVS

Bloemfontein, Free State, South Africa

Site Status

Wits Clinical Research

Johannesburg, Gauteng, South Africa

Site Status

Synexus Stanza Clincal Reaserch Centre

Pretoria, Gauteng, South Africa

Site Status

Watermeyer Clinical Research Site

Pretoria, Gauteng, South Africa

Site Status

Synexus Helderberg Clinical Research Centre

Cape Town, Western Cape, South Africa

Site Status

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Diabetes Center

Seoul, Nowon-gu, South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Phramongkutklao Hospital

Bangkok, , Thailand

Site Status

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Site Status

Ivano-Frankivsk National Medical University

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status

Ivano-Frankivsk Central City Clinical Hospital

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status

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

Chernivtsi, , Ukraine

Site Status

Regional Public Organization "Chernivtsi Regional Endocrinology Center"

Chernivtsi, , Ukraine

Site Status

State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine

Dnipro, , Ukraine

Site Status

Municipal nonprofit entity of Kharkiv municipal council

Kharkiv, , Ukraine

Site Status

L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine

Kharkiv, , Ukraine

Site Status

Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"

Kharkiv, , Ukraine

Site Status

Communal Institution Kherson City Clinical Hospital

Kherson, , Ukraine

Site Status

Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

Kyiv, , Ukraine

Site Status

Kyiv clinical hospital on railway transport #2 of the "Healthcare Centre" branch of JSC "Ukrainian Railway"

Kyiv, , Ukraine

Site Status

Medical Center Universal Clinic Oberig

Kyiv, , Ukraine

Site Status

Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

Kyiv, , Ukraine

Site Status

Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

Odesa, , Ukraine

Site Status

Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

Odesa, , Ukraine

Site Status

Poltava Regional Clinical Hospital

Poltava, , Ukraine

Site Status

Ternopil University Hospital

Ternopil, , Ukraine

Site Status

Private Small-Scale Enterprise Medical Centre Pulse

Vinnytsia, , Ukraine

Site Status

Vinnytsia Regional Clinical highly specialized Endocrinology Centre

Vinnytsia, , Ukraine

Site Status

Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia

Vinnytsia, , Ukraine

Site Status

6th City Clinical Hospital, c. Zaporizhzhia

Zaporizhzhia, , Ukraine

Site Status

Municipal Institution, City Hospital #7

Zaporizhzhia, , Ukraine

Site Status

Biomedical Research Centre

Nottingham, East Midland, United Kingdom

Site Status

MAC Clinical Research Manchester

Manchester, Greater Manchester, United Kingdom

Site Status

Royal Oldham Hospital

Oldham, Lancashire, United Kingdom

Site Status

MAC Research, Exchange House

Cannock, Staffordshire, United Kingdom

Site Status

MAC Clinical Research, Monarch House

Leeds, West Yorkshire, United Kingdom

Site Status

MAC Research

Barnsley, , United Kingdom

Site Status

MAC Clinical Research, Kaman Court

Blackpool, , United Kingdom

Site Status

Mid Essex Hospital Services NHS Trust Broomfield Hospital

Chelmsford, , United Kingdom

Site Status

MAC Clinical Research

Liverpool, , United Kingdom

Site Status

MAC Clinical Research, GAC House

Stockton-on-Tees, , United Kingdom

Site Status

Countries

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France Italy Puerto Rico Romania Saudi Arabia Spain United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Colombia Denmark Germany Hungary India Israel Latvia Malaysia Mexico Philippines Poland Russia Singapore South Africa South Korea Thailand Ukraine United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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RLM-MD-03

Identifier Type: -

Identifier Source: org_study_id