MedPath

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

Phase 3
Terminated
Conditions
Gastroparesis
Diabetes Mellitus
Interventions
Drug: Placebo
Registration Number
NCT03383146
Lead Sponsor
Allergan
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
450
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Relamorelin 10 μgRelamorelinRelamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Primary Outcome Measures
NameTimeMethod
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)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

Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.

Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory ResultsUp to 52 weeks

Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) ResultsUp to 52 weeks

A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

Change From Baseline to Week 52 in the Weekly Average DGSSSBaseline (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

Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.

Number of Participants With Clinically Meaningful Trends for Vital SignsUp to 52 weeks

Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.

Number of Participants With Anti-relamorelin Antibody Testing Results by VisitBaseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)

A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.

Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.

Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c)Up to 52 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (334)

Atlanta Diabetes Associates

🇺🇸

Atlanta, Georgia, United States

Endocrinology Research Associates, Inc.

🇺🇸

Columbus, Ohio, United States

Texas Clinical Research Institute, LLC

🇺🇸

Arlington, Texas, United States

Bhatia Hospital

🇮🇳

Mumbai, Maharashtra, India

B. J. Government Medical College and Sassoon General Hospitals

🇮🇳

Pune, Maharashtra, India

Eternal Hospital - Diabetology

🇮🇳

Jaipur, Rajasthan, India

Noble Hospital

🇮🇳

Pune, Maharashtra, India

Marudhar Hospital

🇮🇳

Jaipur, Rajasthan, India

Wits Clinical Research

🇿🇦

Johannesburg, Gauteng, South Africa

Diagnamics Inc.

🇺🇸

Encinitas, California, United States

Pinnacle Research Group

🇺🇸

Anniston, Alabama, United States

VVCRD Research

🇺🇸

Garden Grove, California, United States

Upland Clinical Research

🇺🇸

Upland, California, United States

Om Research LLC

🇺🇸

Lancaster, California, United States

G & L Research, LLC

🇺🇸

Foley, Alabama, United States

Kindred Medical Institute for Clinical Trials, LLC

🇺🇸

Corona, California, United States

Meritus Center for Clinical Research

🇺🇸

Hagerstown, Maryland, United States

MNGI Digestive Health

🇺🇸

Coon Rapids, Minnesota, United States

Applied Research Center of Arkansas

🇺🇸

Little Rock, Arkansas, United States

Synexus

🇺🇸

Pinellas Park, Florida, United States

Stanford Hospital

🇺🇸

Palo Alto, California, United States

Peak Gastroenterology Associates

🇺🇸

Colorado Springs, Colorado, United States

Top Medical Research

🇺🇸

Cutler Bay, Florida, United States

MediSphere Medical Research Center, LLC

🇺🇸

Evansville, Indiana, United States

Gastro Center of Maryland

🇺🇸

Columbia, Maryland, United States

Gastroenterology Associates of Fairfield County, P.C.

🇺🇸

Bridgeport, Connecticut, United States

Woodholme Gastroenterology Associates, P.A.

🇺🇸

Glen Burnie, Maryland, United States

Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

🇺🇸

Chevy Chase, Maryland, United States

American Research, LLC

🇺🇸

Jeffersonville, Indiana, United States

Frederick Gastroenterology Associates, PA an Elligo Health Research Site

🇺🇸

Frederick, Maryland, United States

Diabetes and Endocrinology Consultants, PC

🇺🇸

Morehead City, North Carolina, United States

Hometown Urgent Care and Research

🇺🇸

Dayton, Ohio, United States

WK Physicians Network

🇺🇸

Bossier City, Louisiana, United States

Long Island Gastrointestinal Research Group LLP

🇺🇸

Great Neck, New York, United States

Carolinas Healthcare-Charlotte

🇺🇸

Charlotte, North Carolina, United States

Cronola LLC

🇺🇸

Houma, Louisiana, United States

Diabetes & Endocrinology Associates of Stark County, Inc.

🇺🇸

Canton, Ohio, United States

Carolina Digestive Health Associates, PA

🇺🇸

Concord, North Carolina, United States

Triad Clinical Trials

🇺🇸

Greensboro, North Carolina, United States

Clinsearch

🇺🇸

Chattanooga, Tennessee, United States

United Health Services Hospitals, Inc.

🇺🇸

Johnson City, New York, United States

PMG Research of Wilmington, LLC

🇺🇸

Wilmington, North Carolina, United States

Trial Management Associates, LLC

🇺🇸

Wilmington, North Carolina, United States

Gastroenterology Centers of the Midsouth

🇺🇸

Germantown, Tennessee, United States

Vidant Multispeciality Clinic - Kinston

🇺🇸

Kinston, North Carolina, United States

Advanced Clinical Research

🇺🇸

West Jordan, Utah, United States

Gastroenterology Associates, PA

🇺🇸

Greenville, South Carolina, United States

Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated

🇦🇺

Adelaide, South Australia, Australia

Frontier Clinical Research, LLC

🇺🇸

Smithfield, Pennsylvania, United States

Aventiv Research, Inc.

🇺🇸

Columbus, Ohio, United States

Premier Clinical Research d.b.a. STAT Research

🇺🇸

Franklin, Ohio, United States

Health Concepts

🇺🇸

Rapid City, South Dakota, United States

Hospital Universitário João de Barros Barreto - UFPA

🇧🇷

Belem, PA, Brazil

Nepean Hospital

🇦🇺

Kingswood, New South Wales, Australia

Ordination

🇦🇹

Osterreicher, Steiermark, Austria

KRH Klinikum Siloah

🇩🇪

Hannover, Germany

Hospital Universitário Walter Cantídio

🇧🇷

Fortaleza, CE, Brazil

Digestive Diseases Centre GASTRO

🇱🇻

Riga, Latvia

Verity Research Inc.

🇺🇸

Fairfax, Virginia, United States

IPEC-Instituto de Pesquisa Clinica

🇧🇷

Sao Paulo, Brazil

SMS Hospital

🇮🇳

Jaipur, Rajasthan, India

Royal Melbourne Hospital

🇦🇺

Parkville, Victoria, Australia

The Ottawa Hospital

🇨🇦

Ottawa, Ontario, Canada

Clinical Research Hamburg

🇩🇪

Hamburg, Germany

Alexandrovska University Hospital

🇧🇬

Sofia, Bulgaria

Israelitisches Krankenhaus

🇩🇪

Hamburg, Germany

Chonbuk National University Hospital

🇰🇷

Jeonju, Jeollabuk-Do, Korea, Republic of

Studienzentrum Schwittay

🇩🇪

Böhlen, Saxony, Germany

S R Kalla (SRK) Memorial Gastro & General Hospital

🇮🇳

Jaipur, Rajasthan, India

Hetenyi Geza Hospital

🇭🇺

Szolnok, Jász-Nagykun-Szolnok, Hungary

Sanggye Paik Hospital, Inje University College of Medicine

🇰🇷

Seoul, Nowon-gu, Korea, Republic of

Synexus Helderberg Clinical Research Centre

🇿🇦

Somerset West, South Africa

Biomedical Research Centre

🇬🇧

Nottingham, East Midland, United Kingdom

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Centro de Atención e Investigación en Factores de Riesgo Car

🇲🇽

Mexico, Distrito Federal, Mexico

Dioderm Instituto de Investigacion

🇲🇽

Durango, Mexico

Watermeyer Clinical Research Site

🇿🇦

Pretoria, Val De Grace, South Africa

St. Luke's Medical Center

🇵🇭

Quezon City, Philippines

CenterMed Krakow Ltd

🇵🇱

Krakow, Malopolska, Poland

MAC Clinical Research

🇬🇧

Liverpool, Merseyside, United Kingdom

MAC Clinical Research, GAC House

🇬🇧

Manchester, United Kingdom

Vinnytsia Regional Clinical highly specialized Endocrinology Centre

🇺🇦

Vinnytsia, Ukraine

MAC Clinical Research, Kaman Court

🇬🇧

Blackpool, United Kingdom

MAC Research

🇬🇧

Barnsley, United Kingdom

APF Research LLC

🇺🇸

Miami, Florida, United States

Advanced Medical Research Institute

🇺🇸

Miami, Florida, United States

American Research Institute, Inc

🇺🇸

Miami, Florida, United States

Houston Endoscopy and Research Center, Inc.

🇺🇸

Houston, Texas, United States

Optimal Research California

🇺🇸

San Diego, California, United States

Medical Associates Research Group, Inc

🇺🇸

San Diego, California, United States

Quality Medical Research

🇺🇸

Nashville, Tennessee, United States

Pinnacle Clinical Research

🇺🇸

San Antonio, Texas, United States

Health Science Research Center

🇺🇸

Pratt, Kansas, United States

Via Christi Clinic, PA

🇺🇸

Wichita, Kansas, United States

Cotton-O'Neil Clinical Research Center - Digestive Health

🇺🇸

Topeka, Kansas, United States

WestGlen Gastrointestinal Consultants

🇺🇸

Shawnee Mission, Kansas, United States

Centro de Pesquisa Clinica do Brasil

🇧🇷

Brasilia, Distrito Federal, Brazil

M.V. Hospital for Diabetes & Diabetes Research Centre

🇮🇳

Chennai, Tamil Nadu, India

Arthur Asirvatham Hospital

🇮🇳

Madurai, Tamil Nadu, India

Kansas Medical Clinic

🇺🇸

Topeka, Kansas, United States

Phoenix Clinical LLC.

🇺🇸

Phoenix, Arizona, United States

Núcleo de Pesquisa Clínica do Rio Grande do Sul

🇧🇷

Porto Alegre, Rio Grande Do Sul, Brazil

Digestive Health Specialist of the South East

🇺🇸

Dothan, Alabama, United States

Avant Research Associates

🇺🇸

Huntsville, Alabama, United States

Alabama Medical Group, PC

🇺🇸

Mobile, Alabama, United States

Synexus Clinical Research US, Inc.

🇺🇸

Murray, Utah, United States

Aurora Care Clinic, LLC

🇺🇸

Costa Mesa, California, United States

TriWest Research Associates

🇺🇸

El Cajon, California, United States

Palmetto Research, LLC

🇺🇸

Hialeah, Florida, United States

Vida Clinical Trials

🇺🇸

Homestead, Florida, United States

Savin Medical Group LLC

🇺🇸

Miami Lakes, Florida, United States

Nature Coast Clinical Research

🇺🇸

Inverness, Florida, United States

Florida Research Center, Inc.

🇺🇸

Miami, Florida, United States

Gastroenterology Group of Naples

🇺🇸

Naples, Florida, United States

Sensible Healthcare

🇺🇸

Ocoee, Florida, United States

River Birch Research Alliance, LLC

🇺🇸

Blue Ridge, Georgia, United States

Gwinnett Research Institute, LLC

🇺🇸

Buford, Georgia, United States

Professional Research Network of Kansas, LLC

🇺🇸

Wichita, Kansas, United States

St. Elizabeth Healthcare â€" Clinical Research Institute

🇺🇸

Erlanger, Kentucky, United States

Vida Clinical Studies

🇺🇸

Dearborn, Michigan, United States

Asheville Gastroenterology Associates

🇺🇸

Asheville, North Carolina, United States

PMG Research Salisbury

🇺🇸

Salisbury, North Carolina, United States

Synexus Clinical Research US - Cincinnati

🇺🇸

Cincinnati, Ohio, United States

Preferred Primary Care Physicians, Inc.

🇺🇸

Pittsburgh, Pennsylvania, United States

Allegheny Endocrinology Associates

🇺🇸

Pittsburgh, Pennsylvania, United States

Centennial Health-Synexus

🇺🇸

Oklahoma City, Oklahoma, United States

Digestive Disease Specialists Inc

🇺🇸

Oklahoma City, Oklahoma, United States

Memorial Clinical Research

🇺🇸

Oklahoma City, Oklahoma, United States

DiscoveResearch, Inc.

🇺🇸

Beaumont, Texas, United States

ClinRx Research, LLC

🇺🇸

Carrollton, Texas, United States

Rodriguez Clinical Trials

🇺🇸

Houston, Texas, United States

Advanced Research Institute, Inc.

🇺🇸

Ogden, Utah, United States

Clinical Trials of Texas, Inc.

🇺🇸

San Antonio, Texas, United States

Centro de Investigaciones Medicas Mar del Plata SRL

🇦🇷

Mar del Plata, Buenos Aires, Argentina

Instituto de Pesquisa Clinica em Campinas

🇧🇷

Campinas, Sao Paulo, Brazil

CPQuali Pesquisa Clinica Ltda

🇧🇷

Sao Paulo, Brazil

Diacon Hospital and research Center - Diabetology

🇮🇳

Bengaluru, Karnataka, India

Synexus Stanza Clinical Research Centre

🇿🇦

Pretoria, Gauteng, South Africa

Simon Williamson Clinic

🇺🇸

Birmingham, Alabama, United States

Northwest Gastroenterology Clinic, LLC

🇺🇸

Portland, Oregon, United States

Steno Diabetes Center Copenhagen

🇩🇰

Hellerup, Copenhagen, Denmark

Gastroenheden, Hvidovre hospital

🇩🇰

Hvidovre, København, Denmark

MAC Clinical Research Manchester

🇬🇧

Manchester, Greater Manchester, United Kingdom

MAC Clinical Research, Monarch House

🇬🇧

Leeds, West Yorkshire, United Kingdom

Mid Essex Hospital Services NHS Trust Broomfield Hospital

🇬🇧

Chelmsford, United Kingdom

Arkansas Gastroenterology

🇺🇸

North Little Rock, Arkansas, United States

Del Sol Research Management, LLC

🇺🇸

Tucson, Arizona, United States

Medical Research Center of Connecticut, LLC

🇺🇸

Hamden, Connecticut, United States

Clinical Trials of SWLA, LLC

🇺🇸

Lake Charles, Louisiana, United States

Tandem Clinical Research

🇺🇸

Marrero, Louisiana, United States

Preferred Research Partners, Inc.

🇺🇸

Little Rock, Arkansas, United States

Unity Health - Searcy Medical Center

🇺🇸

Searcy, Arkansas, United States

Rocky Mountain Diabetes and Osteoporosis Center, PA

🇺🇸

Idaho Falls, Idaho, United States

Clinical Research Institute of Michigan

🇺🇸

Chesterfield, Michigan, United States

Gastroenterology Associates of Western Michigan, West Michigan Clinical Research Center

🇺🇸

Wyoming, Michigan, United States

Synexus Clinical Research US, Inc

🇺🇸

Anderson, South Carolina, United States

Clinical Research of South Nevada - CROSN

🇺🇸

Las Vegas, Nevada, United States

CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian

🇦🇷

Cordoba, Argentina

Privatklinik wehlre-Diakonissen

🇦🇹

Salzburg, Austria

Oö. Gesundheits- und Spitals-AG/LKH Steyr

🇦🇹

Steyr, Austria

AZ Sint Lucas Brugge

🇧🇪

Brugge, West-Vlaanderen, Belgium

Carolina Medical Research

🇺🇸

Clinton, South Carolina, United States

Synexus Clinical Research

🇺🇸

Greer, South Carolina, United States

Instituto Medico Catamarca-I.ME.C

🇦🇷

Rosario, Santa Fe, Argentina

Montana Medical Research

🇺🇸

Missoula, Montana, United States

Avant Research Associates LLC

🇺🇸

Crowley, Louisiana, United States

Diabetes and Endocrine Associates, P.C.

🇺🇸

Omaha, Nebraska, United States

Clinical Trials of America, Inc.

🇺🇸

West Monroe, Louisiana, United States

Aa Mrc, Llc

🇺🇸

Flint, Michigan, United States

National Clinical, LLC

🇺🇸

Hamtramck, Michigan, United States

Garden State Endocrinology LLC

🇺🇸

Brick, New Jersey, United States

Excel Clinical Research

🇺🇸

Las Vegas, Nevada, United States

Advanced Biomedical Research of America

🇺🇸

Las Vegas, Nevada, United States

AGA Clinical Research Associates, LLC

🇺🇸

Egg Harbor Township, New Jersey, United States

Digestive Disease Specialists

🇺🇸

Las Vegas, Nevada, United States

Palm Research Center

🇺🇸

Las Vegas, Nevada, United States

Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

🇧🇪

Edegem, Antwerp, Belgium

East Tennessee Research Institute

🇺🇸

Johnson City, Tennessee, United States

CIPREC

🇦🇷

Buenos Aires, Ciudad Autonoma deBuenos Aires, Argentina

West Virginia University

🇺🇸

Morgantown, West Virginia, United States

Instituto Catarinense de Endocrinologia e Diabetes (ICED)

🇧🇷

Joinville, Santa Catarina, Brazil

Consultorios Asociados de Endocrinologia e Investigación Cl

🇦🇷

Buenos Aires, Buenos Aires Province, Argentina

Hospital Sirio Libanes

🇦🇷

Caba, Buenos Aires Province, Argentina

Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

🇦🇷

San Miguel de Tucuman, Tucuman, Argentina

Centro Universitario de Investigacion en Farmacologia Clinic

🇦🇷

Corrientes, Argentina

Instituto Privado de Investigaciones Clinicas de Cordoba

🇦🇷

Córdoba, Argentina

UMHAT - Kaspela- EOOD

🇧🇬

Plovdiv, Bulgaria

VIVIT Institute, am LKH Feldkirch

🇦🇹

Feldkirch, Vorarlberg, Austria

UZ Brussel

🇧🇪

Jette, Brussel, Belgium

Recherche GCP Research

🇨🇦

Montreal, Quebec, Canada

South Shore Medical Arts

🇨🇦

Bridgewater, Nova Scotia, Canada

MHAT Yuliya Vrevska Byala

🇧🇬

Byala, Ruse, Bulgaria

Medical Center Asklepion - Humane Medicine Research EOOD

🇧🇬

Sofia, Bulgaria

Centro Cardiovascular y de Diabetes

🇨🇴

Barranquilla, Atlantico, Colombia

Asociación Colombiana de Diabetes

🇨🇴

Bogotá, Cundinamarca, Colombia

Endocare Ltda.

🇨🇴

Bogotá, Distrito Capital De Bogotá, Colombia

Centro Cardiovascular Colombiano Clínica Santa María

🇨🇴

Medellin, Antioquia, Colombia

University of Calgary

🇨🇦

Calgary, Alberta, Canada

Vancouver General Hospital

🇨🇦

Vancouver, British Columbia, Canada

Central Alberta Research Centre

🇨🇦

Red Deer, Alberta, Canada

Patient research centre

🇨🇦

St. John's, Newfoundland and Labrador, Canada

Healthy Medical Center

🇨🇴

Zipaquira, Cundinamarca, Colombia

Kumudini Devi Diabetes Research Center; Ramdevrao Hospital

🇮🇳

Hyderabad, Andhra Pradesh, India

IPS Centro Medico Julian Coronel S.A

🇨🇴

Cali, Valle Del Cauca, Colombia

Rodrigo Botero S.A.S.

🇨🇴

Medellín, Antioquia, Colombia

Fundación del Caribe para la InvestigacionBiomédica-Fundación BIOS

🇨🇴

Barranquilla, Atlantico, Colombia

Medplus Centro de Recuperacion Integral S.A.S.

🇨🇴

Bogotá, Distrito Capital, Colombia

M V Hospital & Research Centre

🇮🇳

Lucknow, Uttar Pradesh, India

Lifecare Clinic and Research Centre - Internal Med/Diabetology

🇮🇳

Bangalore, Karnataka, India

Centro de Investigaciones Clínicas IPS CARDIOMET Pereira

🇨🇴

Pereira, Risaralda, Colombia

King George Hospital

🇮🇳

Visakhapatnam, Andhra Pradesh, India

Zala Megyei Szent Rafael Korhaz

🇭🇺

Zalaegerszeg, Zala, Hungary

Bnei-Zion MC

🇮🇱

Haifa, Israel

Polana-D

🇱🇻

Daugavpils, Latvia

Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

🇱🇻

Riga, Latvia

Clinical Trial Unit, School of Medical Sciences, Health Campus, Hospital Universiti Sains Malaysia

🇲🇾

Kubang Kerian, Malaysia

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

🇲🇽

Mexico, Distrito Federal, Mexico

Centro Medico Imbanaco de Cali S.A.

🇨🇴

Cali, Valle Del Cauca, Colombia

Zydus Hospital

🇮🇳

Ahmedabad, Gujarat, India

Klinische Forschung Dresden GmbH

🇩🇪

Dresden, Saxony, Germany

Markhot Ferenc Oktatokorhaz es Rendelointezet

🇭🇺

Eger, Heves, Hungary

Szegedi TudomanyegyetemSzent-Gyorgyi Albert Klinikai Kozpont és Altalanos Orvostudomanyi Kar Belgyogyaszati Klinika

🇭🇺

Szeged, Hungary

Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology

🇮🇳

Ahmedabad, Gujarat, India

Strázsahegy Gyógyszertár Medicina

🇭🇺

Budapest, Hungary

Victoria Hospital Bangalore Medical College and Research Institute

🇮🇳

Bengaluru, Karnataka, India

Rajalakshmi Hospital

🇮🇳

Bengaluru, Karnataka, India

Universal Hospital

🇮🇳

Pune, Maharashtra, India

Hospital Cardiologica Aguascalientes

🇲🇽

Aguascalientes, Mexico

Cardinal Santos Medical Center

🇵🇭

San Juan City, Metro Manila, Philippines

Manila Doctors Hospital, Ermita

🇵🇭

Manila, Metropolitan Manila, Philippines

Saint-Petersburg City Pokrovskaya Hospital

🇷🇺

St-Petersburg, Leningrad Region, Russian Federation

Sir Ganga Ram Hospital (SGRH)

🇮🇳

Delhi, India

Vinaya Hospital & Research Centre

🇮🇳

Mangalore, India

Kraslava Hospital

🇱🇻

Kraslava, Kraslavas Nov., Latvia

Clinical Investigation Centre

🇲🇾

Kuala Lumpur, Malaysia

Clinicos Asociados BOCM SC

🇲🇽

Mexico, Distrito Federal, Mexico

Hospital Sultanah Bahiyah

🇲🇾

Alor Setar, Kedah, Malaysia

Hospital Taiping

🇲🇾

Taiping, Malaysia

Unidad de Investigación Clínica en Medicina S.C/

🇲🇽

Guadalajara, Jalisco, Mexico

Mentrials Sa de Cv

🇲🇽

Mexico DF, Distrito Federal, Mexico

Consultorio particular

🇲🇽

Guadalajara, Jalisco, Mexico

Specjalistyczny Gabinet Neurologiczny Marta Banach

🇵🇱

Kraków, Lesser Poland, Poland

Centrum Medyczne Lukamed

🇵🇱

Chojnice, Poland

Changi General Hospital

🇸🇬

Singapore, Singapore

Singapore General Hospital

🇸🇬

Singapore, Singapore

Faculty of Medicine, Siriraj Hospital, Mahidol University

🇹🇭

Bangkok, Thailand

Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

🇲🇽

Aguascalientes, Mexico

Sociedad de Metabolismo y Corazon S.C.

🇲🇽

Veracruz, Mexico

CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)

🇲🇽

Durango, Mexico

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

🇺🇦

Chernivtsi, Ukraine

Communal Institution Kherson City Clinical Hospital

🇺🇦

Kherson, Ukraine

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

🇺🇦

Odesa, Ukraine

Municipal Institution 6th City Clinical Hospital, Dept of Gastroenterology

🇺🇦

Zaporizhzhia, Ukraine

West Visayas State University Medical Center

🇵🇭

IloIlo City, IloIlo, Philippines

San Juan De Dios Educational Foundation, Inc.

🇵🇭

Pasay, Metropolitan Manila, Philippines

Ospital ng Makati

🇵🇭

Makati City, NCR, Philippines

GUZ Saratov City Clinical Hospital 9

🇷🇺

Saratov, Saratov Region, Russian Federation

Perpetual Succor Hospital

🇵🇭

Cebu City, Philippines

Rostov on Don

🇷🇺

Rostov on Don, Russian Federation

National University Hospital

🇸🇬

Singapore, Singapore

Maharaj Nakorn Chiang Mai Hospital

🇹🇭

Chiang Mai, Thailand

Scientific Institute of Clinical and Experimental Lymphology

🇷🇺

Novosibirsk, Russian Federation

Phramongkutklao Hospital

🇹🇭

Bangkok, Thailand

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

🇺🇦

Dnipro, Dnipropetrovs'ka Oblast', Ukraine

Municipal Institution, City Hospital #7, polyclinic department, c. Zaporizhzhia

🇺🇦

Zaporizhzhia, Zaporizhzhia Region, Ukraine

Poltava Regional Clinical Hospital

🇺🇦

Poltava, Ukraine

Royal Oldham Hospital

🇬🇧

Oldham, Lancashire, United Kingdom

Chernivtsi Regional Clinical Hospital

🇺🇦

Chernivtsi, Ukraine

Ivano-Frankivsk National Medical University

🇺🇦

Ivano-Frankivsk, Ukraine

Ivano-Frankivsk Central City Clinical Hospital

🇺🇦

Ivano-Frankivsk, Ukraine

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

🇺🇦

Kharkiv, Ukraine

Municipal nonprofit entity of Kharkiv municipal council

🇺🇦

Kharkiv, Ukraine

Kyiv Railway Clinical Hospital No-2 of Branch of Healthcare Center of the PJSC Ukrainian Railway , Endocrynology Department

🇺🇦

Kyiv, Ukraine

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

🇺🇦

Kyiv, Ukraine

Private Small-Scale Enterprise Medical Centre Pulse

🇺🇦

Vinnytsia, Ukraine

MAC Research, Exchange House

🇬🇧

Cannock, Staffordshire, United Kingdom

University Hospitals of North Midlands

🇬🇧

Stoke on Trent, Staffordshire, United Kingdom

Heartland Clinical Research, Inc

🇺🇸

Omaha, Nebraska, United States

Toronto Digestive Disease Associates, Inc.

🇨🇦

Vaughan, Ontario, Canada

Scentryphar Pesquisa Clínica Ltda

🇧🇷

Campinas, Sao Paulo, Brazil

North Alabama Research Center, LLC

🇺🇸

Athens, Alabama, United States

Klinische Forschung Karlsruhe GmbH

🇩🇪

Karlsruhe, Baden-Wurttemberg, Germany

Options Health Research, LLC

🇺🇸

Tulsa, Oklahoma, United States

Hope Clinical Research

🇺🇸

Canoga Park, California, United States

Torrance Clinical Research Institute, Inc.

🇺🇸

Lomita, California, United States

GW Research Inc

🇺🇸

Chula Vista, California, United States

Angel City Research Inc.

🇺🇸

Los Angeles, California, United States

Syrentis Clinical Research

🇺🇸

Santa Ana, California, United States

New Hope Research Development

🇺🇸

Whittier, California, United States

Innovative Research of West FL, Inc.

🇺🇸

Clearwater, Florida, United States

Clinical Research of West Florida

🇺🇸

Clearwater, Florida, United States

AMPM Research Clinic

🇺🇸

Miami, Florida, United States

Summit Clinical Research, LLC.

🇺🇸

Carnesville, Georgia, United States

iResearch Atlanta LLC

🇺🇸

Decatur, Georgia, United States

Infinite Clinical Trials

🇺🇸

Riverdale, Georgia, United States

North Shore University Health System

🇺🇸

Evanston, Illinois, United States

Southwest Gastroenterology

🇺🇸

Oak Lawn, Illinois, United States

The Ohio State University, Wexner Medical Center

🇺🇸

Columbus, Ohio, United States

CIC America Clinical Inquest Center Ltd.

🇺🇸

Dayton, Ohio, United States

Family Practice Center of Wadsworth, Inc.

🇺🇸

Wadsworth, Ohio, United States

Family Medical Associates, Research Department

🇺🇸

Levittown, Pennsylvania, United States

Baylor College of Medicine Medical Center

🇺🇸

Houston, Texas, United States

Biopharma Informatic Inc., Research Center

🇺🇸

Houston, Texas, United States

Sante Clinical Research

🇺🇸

Kerrville, Texas, United States

Amir Hassan, MD, PA

🇺🇸

Houston, Texas, United States

Sagact Pllc.

🇺🇸

San Antonio, Texas, United States

Blue Ridge Medical Research

🇺🇸

Lynchburg, Virginia, United States

Manassas Clinical Research Centre

🇺🇸

Manassas, Virginia, United States

Washington Gastroenterology PLLC

🇺🇸

Tacoma, Washington, United States

University of Iowa Hospitals and Clinics

🇺🇸

Iowa City, Iowa, United States

ALL Medical Research, LLC

🇺🇸

Cooper City, Florida, United States

Clinical Research Consultants of Atlanta

🇺🇸

Suwanee, Georgia, United States

Dayton Gastroenterology,Inc.

🇺🇸

Beavercreek, Ohio, United States

Preferred Primary Care Physicians

🇺🇸

Uniontown, Pennsylvania, United States

Guthrie Clinical Research

🇺🇸

Sayre, Pennsylvania, United States

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

🇧🇷

Fortaleza, Brazil

Hospital Universitario Principe de Asturias

🇪🇸

Madrid, Spain

University of Louisville

🇺🇸

Louisville, Kentucky, United States

PMG Research of Winston-Salem, LLC

🇺🇸

Winston-Salem, North Carolina, United States

The Center for Clinical Research

🇺🇸

Winston-Salem, North Carolina, United States

VA Medical Center McGuire VAMC

🇺🇸

Richmond, Virginia, United States

University of North Carolina at Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

Clinical Trials of South Carolina

🇺🇸

Charleston, South Carolina, United States

Centro de Desarrollo Biomédico S.C.P

🇲🇽

Mérida, Yucatán, Mexico

Lovelace Scientific Resources, Inc.

🇺🇸

Albuquerque, New Mexico, United States

CHEAR Center LLC

🇺🇸

Bronx, New York, United States

Kovai Diabetes Speciality Centre

🇮🇳

Coimbatore, Tamil Nadu, India

University of California San Diego

🇺🇸

La Jolla, California, United States

Cumberland Research Associates, LLC

🇺🇸

Fayetteville, North Carolina, United States

Unidad de Investigacion Clinica Cardiometabolica de Occidente

🇲🇽

Guadalajara, Jalisco, Mexico

Instituto de Investigaciones Clinicas de Rosario

🇦🇷

Rosario, Santa Fe, Argentina

Meridian Clinical Research, LLC

🇺🇸

Rockville, Maryland, United States

FARMOVS

🇿🇦

Bloemfontein, Free State, South Africa

University of Kansas Medical Center

🇺🇸

Kansas City, Kansas, United States

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