A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

Diabetes Mellitus Clinical Trial

Official title:

A 12-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: NCT03285308
• Other study ID #: RLM-MD-01
• Secondary ID: 2017-002136-16
• Status: Terminated
• Phase: Phase 3
• Start date: September 29, 2017
• Est. completion date: July 8, 2020

Study information

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

Clinical Trial Summary

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 336
• Est. completion date: July 8, 2020
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Type 1 or Type 2 diabetes mellitus

• Meet the per protocol criteria of diabetic gastroparesis

• Compliance with diary

• Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

• Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube

• Actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating disorder at the time of Screening (Visit 1)

• Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity

• History of gastrointestinal disorders that may be similar to gastroparesis

• Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

Related Conditions & MeSH terms

• Diabetes Mellitus
• Gastroparesis

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated	Adelaide	South Australia
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria
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
France	CHU Nantes	Nantes Cedex 1
France	Hopital Charles Nicolle	Rouen Cedex
India	Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology	Ahmedabad	Gujarat
India	Life Care Hospital & Research Centre	Bangalore	Karnataka
India	Victoria Hospital	Bangalore	Karnataka
India	Diacon Hospital and research Center - Diabetology	Bengaluru	Karnataka
India	Rajalakshmi Hospital	Bengaluru	Karnataka
India	M.V. Hospital for Diabetes & Diabetes Research Centre	Chennai	Tamil Nadu
India	Kovai Diabetes Speciality Centre	Coimbatore	Tamil Nadu
India	Kumudini Devi Diabetes Research Center; Ramdevrao Hospital	Hyderabad	Andhra Pradesh
India	Diabetic Thyroid and Endocrine Centre	Jaipur	Rajasthan
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
India	Vinaya Hospital & Research Centre	Mangalore	Karnataka
India	Bhatia Hospital	Mumbai	Maharashtra
India	Sir Ganga Ram Hospital	New Delhi
India	B. J. Government Medical College and Sassoon General Hospitals	Pune	Maharashtra
India	Noble Hospital Pvt. Ltd	Pune	Maharashtra
India	Universal Hospital	Pune	Maharashtra
India	King George Hospital	Visakhapatnam	Andhra Pradesh
Israel	Soroka University Medical Center	Beer Sheba
Israel	Bnai Zion Medical Center	Haifa
Israel	E. Wolfson Medical Center	Holon
Israel	Digestive Diseases Institute	Jerusalem
Israel	Gastroenterology Institute	Petach Tikva
Israel	Endocrinology & Diabetes Center	Safed
Israel	Gastroenterology Institute	Tel Aviv
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
Malaysia	Hospital Sultanah Bahiyah	Alor Setar	Kedah
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Universiti Sains Malaysia	Kubang Kerian
Malaysia	Hospital Taiping	Taiping
Philippines	Perpetual Succor Hospital	Cebu City
Philippines	Manila Doctors Hospital	Ermita	Manila
Philippines	West Visayas State University Medical Center	IloIlo City
Philippines	Ospital ng Makati	Makati City	NCR
Philippines	San Juan De Dios Educational Foundation, Inc.	Pasay	Metro Manila
Philippines	St. Luke's Medical Center	Quezon City
Philippines	Cardinal Santos Medical Center	San Juan City	Metro Manila
Poland	NZOZ Vita Diabetica - Malgorzata Buraczyk	Bialystok
Poland	Centrum Medyczne Lukamed	Chojnice
Poland	Synexus Polska sp.z.o.o oddzial Czestochowa	Czestochowa
Poland	CenterMed Krakow Ltd	Krakow	Malopolska
Poland	Specjalistyczny Gabinet Neurologiczny Marta Banach	Kraków
Poland	Synexus Polska Sp. z o.o. Oddzial w Lodzi	Lodz
Poland	Sanitas Centrum Medyczne	Lublin
Poland	Wojewodzki Szpital Specjalistyczny w Olsztynie	Olsztyn	Warmia-Mazury
Poland	Synexus Polska Sp.z o.o.	Pomorskie	Gdansk
Poland	Synexus Polska Sp. z o.o.Oddzial w Poznaniu	Poznan	Poznañ
Poland	Endoskopia Sp. Z O.O.	Sopot	Pomorskie
Poland	Centrum Medyczne Pratia S.A. Warsaw, Poland	Warsaw	Mazowian
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa
Poland	Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska	Wroclaw
Poland	DRS Wroclaw	Wroclaw
Singapore	Changi General Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Spain	Hospital Universitario Principe de Asturias	Madrid
Spain	Hospital Universitario De Salamanca	Salamanca
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Thailand	Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai
Ukraine	Regional 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 diseases, c.C	Chernivtsi
Ukraine	Regional Public Organization Chernivtsi Regional Endocrinology Center	Chernivtsi
Ukraine	State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine	Dnipro
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	L.T.Malaya Therapy National Institute of the 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	AS Medbud Clinic	Kyiv
Ukraine	AS PVNZ	Kyiv
Ukraine	Kyiv municipal clinical endocrinological center	Kyiv
Ukraine	Kyiv Railway hospital on the railway transport #2 of the branch "health	Kyiv
Ukraine	Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv	Kyiv
Ukraine	Medical Center Universal Clinic Oberig	Kyiv
Ukraine	Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit	Kyiv
Ukraine	Communal Institution "Odesa Regional Clinical Hospital", Out-patient department	Odesa	Odesa Region
Ukraine	Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University	Odesa
Ukraine	Poltava Regional Clinical Hospital	Poltava
Ukraine	Ternopil University Hospital	Ternopil
Ukraine	Limited Liability Company "Medical Center "Salutem"	Vinnitsa	Vinnyts'ka Oblast'
Ukraine	Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia	Vinnytsia
Ukraine	Private Small-Scale Enterprise Medical Centre Pulse	Vinnytsia
Ukraine	Vinnytsia Regional Clinical highly specialized Endocrinology Centre	Vinnytsia
Ukraine	6th City Clinical Hospital, c. Zaporizhzhia	Zaporizhzhia
Ukraine	Municipal Institution City Hospital No. 7	Zaporizhzhia	Zaporizhzhia Region
United States	Synexus Clinical Research US, Inc.	Anderson	South Carolina
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	University of Colorado, Denver	Aurora	Colorado
United States	Avant Research Associates,LLC	Austin	Texas
United States	Delta Research Partners	Bastrop	Louisiana
United States	Dayton Gastroenterology,Inc.	Beavercreek	Ohio
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Garden State Endocrinology	Brick	New Jersey
United States	Synexus Clinical Research US, Inc.	Bridgeton	New Jersey
United States	Connecticut Clinical Research Foundation	Bristol	Connecticut
United States	CHEAR Center, LLC	Bronx	New York
United States	Hope Clinical Research	Canoga Park	California
United States	Summit Clinical Research, LLC	Carnesville	Georgia
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Carolinas Healthcare-Charlotte	Charlotte	North Carolina
United States	Innovative Research of West FL, Inc.	Clearwater	Florida
United States	West Central Gastroenterology	Clearwater	Florida
United States	Carolina Medical Research	Clinton	South Carolina
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Gastro Center of Maryland	Columbia	Maryland
United States	Endocrinology Research Associates, Inc.	Columbus	Ohio
United States	Hometown Urgent Care and Research	Columbus	Ohio
United States	Carolina Digestive Health Associates	Concord	North Carolina
United States	MNGI Digestive Health	Coon Rapids	Minnesota
United States	Kindred Medical Institute for Clinical Trials, LLC	Corona	California
United States	Aurora Care Clinic, LLC	Costa Mesa	California
United States	Citrus Valley Gastroenterology Clinic	Covina	California
United States	American Research Institute, Inc	Cutler Bay	Florida
United States	Top Medical Research	Cutler Bay	Florida
United States	Synexus Clinical Research US, Inc.	Dallas	Texas
United States	Vida Clinical Studies	Dearborn	Michigan
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	Denver Esophageal and Stomach Center	Englewood	Colorado
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	Synexus Clinical Research US, Inc.	Fountain Hills	Arizona
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	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	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	National Clinical, LLC	Hamtramck	Michigan
United States	Synexus Clinical Research	Henderson	Nevada
United States	Cronola LLC	Houma	Louisiana
United States	Amir Ali Hassan, MD, PA	Houston	Texas
United States	Avant Research Associates	Huntsville	Alabama
United States	Indiana University Health University Hospital	Indianapolis	Indiana
United States	Nature Coast Clinical Research	Inverness	Florida
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	United Health Services Hospitals, Inc.	Johnson City	New York
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California San Diego	La Jolla	California
United States	Om Research LLC	Lancaster	California
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Clinical Research of South Nevada	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	Preferred Research Partners, Inc.	Little Rock	Arkansas
United States	University of Louisville	Louisville	Kentucky
United States	Cfagi Llc	Maitland	Florida
United States	Central Arizona Medical Associates	Mesa	Arizona
United States	New Orleans Research Institute - Metropolitan Gastroenterology Associates	Metairie	Louisiana
United States	Advanced Medical Research Institute	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	West Virginia University	Morgantown	West Virginia
United States	Synexus Clinical Research US, Inc.	Murray	Utah
United States	Quality Medical Research	Nashville	Tennessee
United States	Arkansas Gastorenterology	North Little Rock	Arkansas
United States	Henry Ford Health System	Novi	Michigan
United States	Southwest Gastroenterology	Oak Lawn	Illinois
United States	Sensible Healthcare	Ocoee	Florida
United States	Advanced Research Institute, Inc.	Ogden	Utah
United States	Digestive Disease Specialists Inc	Oklahoma City	Oklahoma
United States	Memorial Clinical Research	Oklahoma City	Oklahoma
United States	Gulf Region Clinical Research Institute	Pensacola	Florida
United States	Phoenix Clinical LLC	Phoenix	Arizona
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	Northwest Gastroenterology Clinic, LLC	Portland	Oregon
United States	Synexus Clinical Research US, Inc.	Richfield	Minnesota
United States	Infinite Clinical Trials	Riverdale	Georgia
United States	PMG Research Salisbury	Salisbury	North Carolina
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Sagact Pllc	San Antonio	Texas
United States	Clinical Applications Laboratories, Inc.	San Diego	California
United States	Medical Associates Research Group, Inc	San Diego	California
United States	Synexus Clinical Research, US, Santa Rosa	Santa Rosa	California
United States	Montgomery Medical, Inc.	Smithfield	Pennsylvania
United States	University of South Florida	Tampa	Florida
United States	West Central Gastroenterology	Tampa	Florida
United States	Cotton-O'Neil Clinical Research Center - Digestive Health	Topeka	Kansas
United States	Del Sol Research Management, LLC	Tucson	Arizona
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	TrialSpark, Inc.	Washington	District of Columbia
United States	Advanced Clinical Research	West Jordan	Utah
United States	Boston VA Healthcare System	West Roxbury	Massachusetts
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	Cardinal Internal Medicine	Woodbridge	Virginia
United States	Gastroenterology Associates of Western Michigan	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  France,  India,  Israel,  Korea, Republic of,  Malaysia,  Philippines,  Poland,  Singapore,  Spain,  Thailand,  Ukraine, 

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.	Baseline (Day-14 to Day-1) to Week 12
Primary	Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.	Week 6 to Week 12
Secondary	Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea.	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary	Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary.	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary	Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary.	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary	Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst).	Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Secondary	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.	Up to approximately 16 weeks
Secondary	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 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.	Up to 12 weeks
Secondary	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 results were clinically significant.	Up to 12 weeks
Secondary	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 12 weeks
Secondary	Number of Participants With a =1% Increase in Glycosylated Hemoglobin A1c (HBA1c)	HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound.	Baseline (Day 1) up to 12 weeks
Secondary	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 14, Day 28, Day 84, and End of Treatment (Up to Day 84)