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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03383146
• Other study ID #: RLM-MD-04
• Secondary ID: 2017-002144-33
• Status: Terminated
• Phase: Phase 3
• Start date: February 1, 2018
• Est. completion date: November 5, 2020

Study information

• Verified date: November 2021
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 450
• Est. completion date: November 5, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Gastroparesis

Intervention

Drug:
• Placebo
Placebo injected subcutaneously twice daily.
• Relamorelin
Relamorelin 10 µg injected subcutaneously twice daily.

Locations

Country	Name	City	State
Argentina	CIPREC	Buenos Aires	Ciudad Autonoma deBuenos Aires
Argentina	Consultorios Asociados de Endocrinologia e Investigación Cl	Buenos Aires	Buenos Aires Province
Argentina	Hospital Sirio Libanes	Caba	Buenos Aires Province
Argentina	CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian	Cordoba
Argentina	Instituto Privado de Investigaciones Clinicas de Cordoba	Córdoba
Argentina	Centro Universitario de Investigacion en Farmacologia Clinic	Corrientes
Argentina	Centro de Investigaciones Medicas Mar del Plata SRL	Mar del Plata	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas de Rosario	Rosario	Santa Fe
Argentina	Instituto Medico Catamarca-I.ME.C	Rosario	Santa Fe
Argentina	Clinica Mayo de Urgencias Medicas Cruz Blanca SRL	San Miguel de Tucuman	Tucuman
Australia	Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated	Adelaide	South Australia
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Austria	VIVIT Institute, am LKH Feldkirch	Feldkirch	Vorarlberg
Austria	Ordination	Osterreicher	Steiermark
Austria	Privatklinik wehlre-Diakonissen	Salzburg
Austria	Oö. Gesundheits- und Spitals-AG/LKH Steyr	Steyr
Belgium	AZ Sint Lucas Brugge	Brugge	West-Vlaanderen
Belgium	Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,	Edegem	Antwerp
Belgium	UZ Brussel	Jette	Brussel
Brazil	Hospital Universitário João de Barros Barreto - UFPA	Belem	PA
Brazil	Centro de Pesquisa Clinica do Brasil	Brasilia	Distrito Federal
Brazil	Instituto de Pesquisa Clinica em Campinas	Campinas	Sao Paulo
Brazil	Scentryphar Pesquisa Clínica Ltda	Campinas	Sao Paulo
Brazil	Hospital Universitário Walter Cantídio	Fortaleza	CE
Brazil	Instituto de Estudos e Pesquisas Clinicas do Ceara IEP/CE - Oncology	Fortaleza
Brazil	Instituto Catarinense de Endocrinologia e Diabetes (ICED)	Joinville	Santa Catarina
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	CPQuali Pesquisa Clinica Ltda	Sao Paulo
Brazil	IPEC-Instituto de Pesquisa Clinica	Sao Paulo
Bulgaria	MHAT Yuliya Vrevska Byala	Byala	Ruse
Bulgaria	UMHAT - Kaspela- EOOD	Plovdiv
Bulgaria	Alexandrovska University Hospital	Sofia
Bulgaria	Medical Center Asklepion - Humane Medicine Research EOOD	Sofia
Canada	South Shore Medical Arts	Bridgewater	Nova Scotia
Canada	University of Calgary	Calgary	Alberta
Canada	Recherche GCP Research	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Central Alberta Research Centre	Red Deer	Alberta
Canada	Patient research centre	St. John's	Newfoundland and Labrador
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates, Inc.	Vaughan	Ontario
Colombia	Centro Cardiovascular y de Diabetes	Barranquilla	Atlantico
Colombia	Fundación del Caribe para la InvestigacionBiomédica-Fundación BIOS	Barranquilla	Atlantico
Colombia	Asociación Colombiana de Diabetes	Bogotá	Cundinamarca
Colombia	Endocare Ltda.	Bogotá	Distrito Capital De Bogotá
Colombia	Medplus Centro de Recuperacion Integral S.A.S.	Bogotá	Distrito Capital
Colombia	Centro Medico Imbanaco de Cali S.A.	Cali	Valle Del Cauca
Colombia	IPS Centro Medico Julian Coronel S.A	Cali	Valle Del Cauca
Colombia	Centro Cardiovascular Colombiano Clínica Santa María	Medellin	Antioquia
Colombia	Rodrigo Botero S.A.S.	Medellín	Antioquia
Colombia	Centro de Investigaciones Clínicas IPS CARDIOMET Pereira	Pereira	Risaralda
Colombia	Healthy Medical Center	Zipaquira	Cundinamarca
Denmark	Steno Diabetes Center Copenhagen	Hellerup	Copenhagen
Denmark	Gastroenheden, Hvidovre hospital	Hvidovre	København
Germany	Studienzentrum Schwittay	Böhlen	Saxony
Germany	Klinische Forschung Dresden GmbH	Dresden	Saxony
Germany	Clinical Research Hamburg	Hamburg
Germany	Israelitisches Krankenhaus	Hamburg
Germany	KRH Klinikum Siloah	Hannover
Germany	Klinische Forschung Karlsruhe GmbH	Karlsruhe	Baden-Wurttemberg
Hungary	Strázsahegy Gyógyszertár Medicina	Budapest
Hungary	Markhot Ferenc Oktatokorhaz es Rendelointezet	Eger	Heves
Hungary	Szegedi TudomanyegyetemSzent-Gyorgyi Albert Klinikai Kozpont és Altalanos Orvostudomanyi Kar Belgyogyaszati Klinika	Szeged
Hungary	Hetenyi Geza Hospital	Szolnok	Jász-Nagykun-Szolnok
Hungary	Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Zala
India	Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology	Ahmedabad	Gujarat
India	Zydus Hospital	Ahmedabad	Gujarat
India	Lifecare Clinic and Research Centre - Internal Med/Diabetology	Bangalore	Karnataka
India	Diacon Hospital and research Center - Diabetology	Bengaluru	Karnataka
India	Rajalakshmi Hospital	Bengaluru	Karnataka
India	Victoria Hospital Bangalore Medical College and Research Institute	Bengaluru	Karnataka
India	M.V. Hospital for Diabetes & Diabetes Research Centre	Chennai	Tamil Nadu
India	Kovai Diabetes Speciality Centre	Coimbatore	Tamil Nadu
India	Sir Ganga Ram Hospital (SGRH)	Delhi
India	Kumudini Devi Diabetes Research Center; Ramdevrao Hospital	Hyderabad	Andhra Pradesh
India	Eternal Hospital - Diabetology	Jaipur	Rajasthan
India	Marudhar Hospital	Jaipur	Rajasthan
India	S R Kalla (SRK) Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	SMS Hospital	Jaipur	Rajasthan
India	M V Hospital & Research Centre	Lucknow	Uttar Pradesh
India	Arthur Asirvatham Hospital	Madurai	Tamil Nadu
India	Vinaya Hospital & Research Centre	Mangalore
India	Bhatia Hospital	Mumbai	Maharashtra
India	B. J. Government Medical College and Sassoon General Hospitals	Pune	Maharashtra
India	Noble Hospital	Pune	Maharashtra
India	Universal Hospital	Pune	Maharashtra
India	King George Hospital	Visakhapatnam	Andhra Pradesh
Israel	Bnei-Zion MC	Haifa
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-Do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Sanggye Paik Hospital, Inje University College of Medicine	Seoul	Nowon-gu
Latvia	Polana-D	Daugavpils
Latvia	Kraslava Hospital	Kraslava	Kraslavas Nov.
Latvia	Digestive Diseases Centre GASTRO	Riga
Latvia	Pauls Stradins Clinical University Hospital, Endokrinologijas nodala	Riga
Malaysia	Hospital Sultanah Bahiyah	Alor Setar	Kedah
Malaysia	Clinical Investigation Centre	Kuala Lumpur
Malaysia	Clinical Trial Unit, School of Medical Sciences, Health Campus, Hospital Universiti Sains Malaysia	Kubang Kerian
Malaysia	Hospital Taiping	Taiping
Mexico	Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV	Aguascalientes
Mexico	Hospital Cardiologica Aguascalientes	Aguascalientes
Mexico	CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)	Durango
Mexico	Dioderm Instituto de Investigacion	Durango
Mexico	Consultorio particular	Guadalajara	Jalisco
Mexico	Unidad de Investigacion Clinica Cardiometabolica de Occidente	Guadalajara	Jalisco
Mexico	Unidad de Investigación Clínica en Medicina S.C/	Guadalajara	Jalisco
Mexico	Centro de Desarrollo Biomédico S.C.P	Mérida	Yucatán
Mexico	Centro de Atención e Investigación en Factores de Riesgo Car	Mexico	Distrito Federal
Mexico	Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology	Mexico	Distrito Federal
Mexico	Clinicos Asociados BOCM SC	Mexico	Distrito Federal
Mexico	Mentrials Sa de Cv	Mexico DF	Distrito Federal
Mexico	Sociedad de Metabolismo y Corazon S.C.	Veracruz
Philippines	Perpetual Succor Hospital	Cebu City
Philippines	West Visayas State University Medical Center	IloIlo City	IloIlo
Philippines	Ospital ng Makati	Makati City	NCR
Philippines	Manila Doctors Hospital, Ermita	Manila	Metropolitan Manila
Philippines	San Juan De Dios Educational Foundation, Inc.	Pasay	Metropolitan Manila
Philippines	St. Luke's Medical Center	Quezon City
Philippines	Cardinal Santos Medical Center	San Juan City	Metro Manila
Poland	Centrum Medyczne Lukamed	Chojnice
Poland	CenterMed Krakow Ltd	Krakow	Malopolska
Poland	Specjalistyczny Gabinet Neurologiczny Marta Banach	Kraków	Lesser Poland
Russian Federation	Scientific Institute of Clinical and Experimental Lymphology	Novosibirsk
Russian Federation	Rostov on Don	Rostov on Don
Russian Federation	GUZ Saratov City Clinical Hospital 9	Saratov	Saratov Region
Russian Federation	Saint-Petersburg City Pokrovskaya Hospital	St-Petersburg	Leningrad Region
Singapore	Changi General Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
South Africa	FARMOVS	Bloemfontein	Free State
South Africa	Wits Clinical Research	Johannesburg	Gauteng
South Africa	Synexus Stanza Clinical Research Centre	Pretoria	Gauteng
South Africa	Watermeyer Clinical Research Site	Pretoria	Val De Grace
South Africa	Synexus Helderberg Clinical Research Centre	Somerset West
Spain	Hospital Universitario Principe de Asturias	Madrid
Thailand	Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai
Ukraine	Chernivtsi Regional Clinical Hospital	Chernivtsi
Ukraine	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	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	Ivano-Frankivsk Central City Clinical Hospital	Ivano-Frankivsk
Ukraine	Ivano-Frankivsk National Medical University	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	Communal Institution Kherson City Clinical Hospital	Kherson
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	Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University	Odesa
Ukraine	Poltava Regional Clinical Hospital	Poltava
Ukraine	Private Small-Scale Enterprise Medical Centre Pulse	Vinnytsia
Ukraine	Vinnytsia Regional Clinical highly specialized Endocrinology Centre	Vinnytsia
Ukraine	Municipal Institution 6th City Clinical Hospital, Dept of Gastroenterology	Zaporizhzhia
Ukraine	Municipal Institution, City Hospital #7, polyclinic department, c. Zaporizhzhia	Zaporizhzhia	Zaporizhzhia Region
United Kingdom	MAC Research	Barnsley
United Kingdom	MAC Clinical Research, Kaman Court	Blackpool
United Kingdom	MAC Research, Exchange House	Cannock	Staffordshire
United Kingdom	Mid Essex Hospital Services NHS Trust Broomfield Hospital	Chelmsford
United Kingdom	MAC Clinical Research, Monarch House	Leeds	West Yorkshire
United Kingdom	MAC Clinical Research	Liverpool	Merseyside
United Kingdom	MAC Clinical Research Manchester	Manchester	Greater Manchester
United Kingdom	MAC Clinical Research, GAC House	Manchester
United Kingdom	Biomedical Research Centre	Nottingham	East Midland
United Kingdom	Royal Oldham Hospital	Oldham	Lancashire
United Kingdom	University Hospitals of North Midlands	Stoke on Trent	Staffordshire
United States	Synexus Clinical Research US, Inc.	Akron	Ohio
United States	Lovelace Scientific Resources, Inc.	Albuquerque	New Mexico
United States	Synexus Clinical Research US, Inc	Anderson	South Carolina
United States	Synexus Clinical Research US, Inc.	Anderson	South Carolina
United States	Pinnacle Research Group	Anniston	Alabama
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	North Alabama Research Center, LLC	Athens	Alabama
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	DiscoveResearch, Inc.	Beaumont	Texas
United States	Dayton Gastroenterology,Inc.	Beavercreek	Ohio
United States	Simon Williamson Clinic	Birmingham	Alabama
United States	River Birch Research Alliance, LLC	Blue Ridge	Georgia
United States	WK Physicians Network	Bossier City	Louisiana
United States	Garden State Endocrinology LLC	Brick	New Jersey
United States	Gastroenterology Associates of Fairfield County, P.C.	Bridgeport	Connecticut
United States	Synexus Clinical Research US, Inc.	Bridgeton	New Jersey
United States	CHEAR Center LLC	Bronx	New York
United States	Gwinnett Research Institute, LLC	Buford	Georgia
United States	Hope Clinical Research	Canoga Park	California
United States	Diabetes & Endocrinology Associates of Stark County, Inc.	Canton	Ohio
United States	Summit Clinical Research, LLC.	Carnesville	Georgia
United States	ClinRx Research, LLC	Carrollton	Texas
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	Carolinas Healthcare-Charlotte	Charlotte	North Carolina
United States	Clinsearch	Chattanooga	Tennessee
United States	Clinical Research Institute of Michigan	Chesterfield	Michigan
United States	Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	GW Research Inc	Chula Vista	California
United States	Synexus Clinical Research US - Cincinnati	Cincinnati	Ohio
United States	Synexus Clinical Research US, Inc	Cincinnati	Ohio
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Innovative Research of West FL, Inc.	Clearwater	Florida
United States	Carolina Medical Research	Clinton	South Carolina
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Synexus	Colorado Springs	Colorado
United States	Gastro Center of Maryland	Columbia	Maryland
United States	Aventiv Research, Inc.	Columbus	Ohio
United States	Endocrinology Research Associates, Inc.	Columbus	Ohio
United States	Hometown Urgent Care and Research	Columbus	Ohio
United States	The Ohio State University, Wexner Medical Center	Columbus	Ohio
United States	Carolina Digestive Health Associates, PA	Concord	North Carolina
United States	MNGI Digestive Health	Coon Rapids	Minnesota
United States	ALL Medical Research, LLC	Cooper City	Florida
United States	Kindred Medical Institute for Clinical Trials, LLC	Corona	California
United States	Aurora Care Clinic, LLC	Costa Mesa	California
United States	Avant Research Associates LLC	Crowley	Louisiana
United States	Top Medical Research	Cutler Bay	Florida
United States	CIC America Clinical Inquest Center Ltd.	Dayton	Ohio
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	Vida Clinical Studies	Dearborn	Michigan
United States	iResearch Atlanta LLC	Decatur	Georgia
United States	Digestive Health Specialist of the South East	Dothan	Alabama
United States	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey
United States	TriWest Research Associates	El Cajon	California
United States	Diagnamics Inc.	Encinitas	California
United States	St. Elizabeth Healthcare â€" Clinical Research Institute	Erlanger	Kentucky
United States	North Shore University Health System	Evanston	Illinois
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Synexus Clinical Research US, Inc.	Evansville	Indiana
United States	Verity Research Inc.	Fairfax	Virginia
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Aa Mrc, Llc	Flint	Michigan
United States	G & L Research, LLC	Foley	Alabama
United States	Premier Clinical Research d.b.a. STAT Research	Franklin	Ohio
United States	Frederick Gastroenterology Associates, PA an Elligo Health Research Site	Frederick	Maryland
United States	VVCRD Research	Garden Grove	California
United States	Gastroenterology Centers of the Midsouth	Germantown	Tennessee
United States	Woodholme Gastroenterology Associates, P.A.	Glen Burnie	Maryland
United States	Long Island Gastrointestinal Research Group LLP	Great Neck	New York
United States	Triad Clinical Trials	Greensboro	North Carolina
United States	Gastroenterology Associates, PA	Greenville	South Carolina
United States	Synexus Clinical Research	Greer	South Carolina
United States	Meritus Center for Clinical Research	Hagerstown	Maryland
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	National Clinical, LLC	Hamtramck	Michigan
United States	Palmetto Research, LLC	Hialeah	Florida
United States	Vida Clinical Trials	Homestead	Florida
United States	Cronola LLC	Houma	Louisiana
United States	Amir Hassan, MD, PA	Houston	Texas
United States	Baylor College of Medicine Medical Center	Houston	Texas
United States	Biopharma Informatic Inc., Research Center	Houston	Texas
United States	Houston Endoscopy and Research Center, Inc.	Houston	Texas
United States	Rodriguez Clinical Trials	Houston	Texas
United States	Avant Research Associates	Huntsville	Alabama
United States	Rocky Mountain Diabetes and Osteoporosis Center, PA	Idaho Falls	Idaho
United States	Nature Coast Clinical Research	Inverness	Florida
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	American Research, LLC	Jeffersonville	Indiana
United States	East Tennessee Research Institute	Johnson City	Tennessee
United States	United Health Services Hospitals, Inc.	Johnson City	New York
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Sante Clinical Research	Kerrville	Texas
United States	Vidant Multispeciality Clinic - Kinston	Kinston	North Carolina
United States	University of California San Diego	La Jolla	California
United States	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana
United States	Om Research LLC	Lancaster	California
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Clinical Research of South Nevada - CROSN	Las Vegas	Nevada
United States	Digestive Disease Specialists	Las Vegas	Nevada
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Palm Research Center	Las Vegas	Nevada
United States	Synexus Clinical Research US, Inc.	Layton	Utah
United States	Family Medical Associates, Research Department	Levittown	Pennsylvania
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Preferred Research Partners, Inc.	Little Rock	Arkansas
United States	Torrance Clinical Research Institute, Inc.	Lomita	California
United States	Angel City Research Inc.	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Manassas Clinical Research Centre	Manassas	Virginia
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Advanced Medical Research Institute	Miami	Florida
United States	American Research Institute, Inc	Miami	Florida
United States	AMPM Research Clinic	Miami	Florida
United States	APF Research LLC	Miami	Florida
United States	Florida Research Center, Inc.	Miami	Florida
United States	Savin Medical Group LLC	Miami Lakes	Florida
United States	Montana Medical Research	Missoula	Montana
United States	Alabama Medical Group, PC	Mobile	Alabama
United States	Diabetes and Endocrinology Consultants, PC	Morehead City	North Carolina
United States	West Virginia University	Morgantown	West Virginia
United States	Synexus Clinical Research US, Inc.	Murray	Utah
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Quality Medical Research	Nashville	Tennessee
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Southwest Gastroenterology	Oak Lawn	Illinois
United States	Sensible Healthcare	Ocoee	Florida
United States	Advanced Research Institute, Inc.	Ogden	Utah
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	Diabetes and Endocrine Associates, P.C.	Omaha	Nebraska
United States	Heartland Clinical Research, Inc	Omaha	Nebraska
United States	Stanford Hospital	Palo Alto	California
United States	Phoenix Clinical LLC.	Phoenix	Arizona
United States	Synexus	Pinellas Park	Florida
United States	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	Northwest Gastroenterology Clinic, LLC	Portland	Oregon
United States	Health Science Research Center	Pratt	Kansas
United States	Health Concepts	Rapid City	South Dakota
United States	Synexus Clinical Research US, Inc.	Richfield	Minnesota
United States	VA Medical Center McGuire VAMC	Richmond	Virginia
United States	Infinite Clinical Trials	Riverdale	Georgia
United States	Meridian Clinical Research, LLC	Rockville	Maryland
United States	Synexus Clinical Research US, Inc	Saint Louis	Missouri
United States	PMG Research Salisbury	Salisbury	North Carolina
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	Sagact Pllc.	San Antonio	Texas
United States	Synexus Clinical Research US, Inc.	San Antonio	Texas
United States	Medical Associates Research Group, Inc	San Diego	California
United States	Optimal Research California	San Diego	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Guthrie Clinical Research	Sayre	Pennsylvania
United States	Frontier Clinical Research, LLC	Scottdale	Pennsylvania
United States	Unity Health - Searcy Medical Center	Searcy	Arkansas
United States	WestGlen Gastrointestinal Consultants	Shawnee Mission	Kansas
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	Clinical Research Consultants of Atlanta	Suwanee	Georgia
United States	Washington Gastroenterology PLLC	Tacoma	Washington
United States	Cotton-O'Neil Clinical Research Center - Digestive Health	Topeka	Kansas
United States	Kansas Medical Clinic	Topeka	Kansas
United States	Del Sol Research Management, LLC	Tucson	Arizona
United States	Del Sol Research Management, LLC	Tucson	Arizona
United States	Synexus Clinical Research US, Inc.	Tucson	Arizona
United States	Options Health Research, LLC	Tulsa	Oklahoma
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Upland Clinical Research	Upland	California
United States	Synexus Clinical Research US, Inc.	Vista	California
United States	Family Practice Center of Wadsworth, Inc.	Wadsworth	Ohio
United States	Advanced Clinical Research	West Jordan	Utah
United States	Clinical Trials of America, Inc.	West Monroe	Louisiana
United States	New Hope Research Development	Whittier	California
United States	Professional Research Network of Kansas, LLC	Wichita	Kansas
United States	Via Christi Clinic, PA	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	Trial Management Associates, LLC	Wilmington	North Carolina
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	Gastroenterology Associates of Western Michigan, West Michigan Clinical Research Center	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Colombia,  Denmark,  Germany,  Hungary,  India,  Israel,  Korea, Republic of,  Latvia,  Malaysia,  Mexico,  Philippines,  Poland,  Russian Federation,  Singapore,  South Africa,  Spain,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)	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.	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
Primary	Change From Baseline to Week 52 in the Weekly Average DGSSS	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.	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
Primary	Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)	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.	First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)
Primary	Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results	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.	Up to 52 weeks
Primary	Number of Participants With Clinically Meaningful Trends for Vital Signs	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.	Up to 52 weeks
Primary	Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results	A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.	Up to 52 weeks
Primary	Number of Participants With a =1% Increase in Glycosylated Hemoglobin A1c (HbA1c)		Up to 52 weeks
Primary	Number of Participants With Anti-relamorelin Antibody Testing Results by Visit	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.	Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)