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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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