Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
2 other identifiers
interventional
393
7 countries
98
Brief Summary
The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1 and Type 2 diabetes mellitus and gastroparesis. Study drug (relamorelin and placebo) will be administered subcutaneously in a blinded fashion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus
Started Jan 2015
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2015
CompletedStudy Start
First participant enrolled
January 29, 2015
CompletedFirst Posted
Study publicly available on registry
February 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2016
CompletedResults Posted
Study results publicly available
July 24, 2019
CompletedJuly 24, 2019
June 1, 2019
1.4 years
January 29, 2015
July 1, 2019
July 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12 in Weekly Vomiting Episodes
Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Each day, the participant recorded the number of vomiting episodes in the past 24 hours in the diary. Higher scores indicate more vomiting episodes. Weekly scores were averaged across the 12 weeks period. A negative change from Baseline indicates improvement.
7 days prior to Day 1 for Baseline to 7 days prior to Week 12
Secondary Outcomes (2)
Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)
7 days prior to Day 1 for Baseline to 7 days prior to Week 12
Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time
Baseline (Day 1) to Week 12
Study Arms (4)
Relamorelin 10 μg
EXPERIMENTALRelamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
Relamorelin 30 μg
EXPERIMENTALRelamorelin 30 μg was administered SC by injection BID for 12 weeks.
Relamorelin 100 μg
EXPERIMENTALRelamorelin 100 μg was administered SC by injection BID for 12 weeks.
Placebo
PLACEBO COMPARATORPlacebo-matching relamorelin was administered SC by injection BID for 12 weeks.
Interventions
Double blind relamorelin was given subcutaneously BID for 12 weeks.
Eligibility Criteria
You may qualify if:
- Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) with stable glycemic control and Hemoglobin A1c (HbA1c) ≤11% at screening.
- Diabetic gastroparesis (DG), defined as at least a 3-month history of symptoms suggestive of gastroparesis on an ongoing basis (e.g., vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain).
- Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) score ≥2.6 at least once during the Screening Period (Visits 1-2).
- At least 2 vomiting episodes during the \~2 weeks prior to the first screening visit (Visit 1), as ascertained by patient history.
- Delayed Gastric Emptying (GE) confirmed at screening by abnormal Gastric Emptying Breath Test (GEBT), defined as GE half-time (t1/2) ≥79 minutes (the 80th percentile of normative data). At least 50% of patients enrolled will have a t1/2 ≥97 minutes (i.e., the 95th percentile).
- Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to Visit 2 (daily adjustments of insulin doses are permitted).
- No use of metoclopramide, erythromycin, domperidone, or other gastrointestinal (GI) motility agents, or anti-emetics for at least 2 weeks prior to Visit 2, and willingness to remain off these medications (except as used as part of protocol-specific rescue medication) during the course of the clinical trial.
- Body mass index \>18 kg/m2.
- If female, has a negative serum or urine pregnancy test and is not lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female patients unable to bear children must have this documented in the electronic case report form (eCRF) (i.e., tubal ligation, hysterectomy, or post-menopausal \[defined as a minimum of 1 year since the last menstrual period\]). Post-menopausal status will be confirmed by measurement of follicle stimulating hormone (FSH).
- Able to provide written informed consent prior to any study procedures and willing and able to comply with study procedures.
- Compliance with the completion of the Diabetic Gastroparesis Symptom Severity Diary (DGSSD) and study drug injections, defined as approximately 80% diary completions and approximately 80% administration of injections, during the 2-week single-blind placebo run-in period. For those patients whose compliance is measured to be \<80%, the final decision to randomize a patient will be made by the Investigator and the Sponsor (or designee).
- At least one vomiting episode at any time during the 2-week single-blind placebo run-in period, as recorded in the DGSSD.
You may not qualify if:
- Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube \[e.g., Percutaneous Endoscopic Gastrostomy (PEG) tube\] for feeding or decompression.
- History of pyloric injection of botulinum toxin within 6 months of screening.
- Patients with clinical suspicion of upper GI obstruction (e.g., peptic stricture) must have been evaluated per standard of care and obstruction ruled out before screening.
- Currently taking opiates, or expecting to use opiates during the course of the clinical trial.
- Currently taking Glucagon-like peptide-1 (GLP-1) agonists, Sodium-glucose co-transporter 2 (SGLT2) inhibitors or pramlintide.
- Allergic or intolerant of egg, wheat, milk, or algae, as these are components of the Gastric emptying breath test (GEBT) study meal. (Gluten-free crackers can be provided.)
- History of anorexia nervosa, binge-eating, or bulimia within 5 years of screening.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 × upper limit of normal (ULN) at Visit 1.
- History of intestinal malabsorption or pancreatic exocrine disease.
- Requires hemodialysis or has end-stage renal disease.
- History of human immunodeficiency virus (HIV) infection.
- Clinically significant neurologic or psychiatric disorders that are likely to impact compliance with protocol requirements.
- Poor venous access or inability to tolerate venipuncture.
- Participation in a clinical study within the 30 days prior to dosing in the present study.
- Any other reason that, in the Investigator's opinion, would confound proper interpretation of the study or expose a patient to unacceptable risk, including renal, hepatic or cardiopulmonary disease, or significant acute electrocardiogram (ECG) abnormalities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (98)
Digestive Health Specialist of the Southeast
Dothan, Alabama, 36305, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Desert Sun Clinical Research
Tucson, Arizona, 85710, United States
Adobe Clinical Research
Tucson, Arizona, 85712, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, 72432, United States
Arkansas Primary Care Clinic
Little Rock, Arkansas, 72204, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211, United States
TriWest Research Associates
El Cajon, California, 92020, United States
Torrance Clinical Research Institute Inc.
Lomita, California, 90717, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
Danbury Hospital- Office of Clinical trials
Danbury, Connecticut, 06810, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
International Research Associates LLC
Hialeah, Florida, 33012, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
APF Research, LLC
Miami, Florida, 33135, United States
Advanced Pharma CR, LLC
Miami, Florida, 33136, United States
Baptist Diabetes Associates, P.A.
Miami, Florida, 33156, United States
Unknown Facility
Miami, Florida, 33175, United States
International Research Associates LLC
Miami, Florida, 33183, United States
Advanced Research Institute Inc
New Port Richey, Florida, 34655, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
River Birch Research Alliance LLC
Blue Ridge, Georgia, 30513, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107, United States
Medisphere Medical Research Center
Evansville, Indiana, 47714, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Delta Research Partners
Monroe, Louisiana, 71201, United States
Clinical Trials of America LA, LLC
West Monroe, Louisiana, 71291, United States
Metropolitan Gastroenterology Group, P.C. (Chevy Chase Clinical Research) Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Detroit Clinical Research Center, PC-Farmington Hills
Farmington Hills, Michigan, 48334, United States
Center For Digestive Health
Troy, Michigan, 48098, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Planters Clinic
Port Gibson, Mississippi, 39150, United States
Impact Clinical Trials
Las Vegas, Nevada, 89106, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Unknown Facility
Great Neck, New York, 11023, United States
New York Clinical Trials, Inc
New York, New York, 10018, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304, United States
OnSite Clinical Solutions- Lexington OnSite Clinical Solutions, LLC
Lexington, North Carolina, 27292, United States
Diabetes and Endocrinology Consultants, P.C.
Morehead City, North Carolina, 28557, United States
OnSite Clinical Solutions, LLC
Statesville, North Carolina, 28117, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
Wake Forest University Baptist Health - Dept of Gastroenterology Medical Center Blvd
Winston-Salem, North Carolina, 27107, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
MetroHealth Medical Center
Leveland, Ohio, 44109, United States
Great Lakes Gastroenterology Research
Mentor, Ohio, 44060, United States
Northwest Gastroenterology Clinic
Portland, Oregon, 97210, United States
Family Medicine of SayeBrook
Myrtle Beach, South Carolina, 29588, United States
ClinSearch LLC
Chattanooga, Tennessee, 37421, United States
Unknown Facility
El Paso, Texas, 79905, United States
GI Specialists of Houston
Houston, Texas, 77015, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas Health Science Center & Medical School at Houston
Houston, Texas, 77030, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Gulf Coast Medical Research, LLC
Sugar Land, Texas, 77478, United States
Aspen Clinical Research
Orem, Utah, 84058, United States
Highland Clinical Research
Salt Lake City, Utah, 84095, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Khan and Abbasi Research
Chester, Virginia, 23831, United States
Healing Hands of Virginia LLC
Richmond, Virginia, 23225, United States
Gastroenterology Consultants
Virginia Beach, Virginia, 23455, United States
ZainResearch, LLC
Richland, Washington, 99352, United States
Hopital Erasme - Universite Libre de Bruxelles
Brussels, 1070, Belgium
UZ Leuven
Leuven, 3000, Belgium
Herz und Diabeteszentrum Nordrhein Westfalen, Universitätsklinikum der Ruhr-Universiät Bochum
Bad Oeynhausen, 32545, Germany
Praxis Dr. Ott Rabenauer Str.
Dippoldiswalde, 01744, Germany
GWT-TUD GmbH
Dresden, 01307, Germany
Israelitisches Krankenhaus Orchideenstig
Hamburg, 22297, Germany
Diabetes Zentrum und Praxis Prof. Pfützner Parcusstr.
Mainz, 55116, Germany
Rambam Health Care Campus - Inst. of Endocrinology, Diabetes, and Metabolism
Haifa, 31096, Israel
Wolfson Medical Center
Holon, 58100, Israel
Rabin Medical Center, Beilinson Hospital Gastroenterology Dept
Petah Tikva, 49100, Israel
ZIV Medical Center
Safed, 13100, Israel
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J. ul.
Bialystok, 15-879, Poland
NZOZ Witamed al.
Kielce, 25-035, Poland
CenterMed Krakow
Krakow, 31530, Poland
Gabinet Lekarski dr n.med. Malgorzata Saryusz-Wolska ul.
Lodz, 90-132, Poland
NZOZ Pulsmedica ul.
Lodz, 93-509, Poland
KO-MED Centra Kliniczne
Staszów, 28-200, Poland
Centrum Badawcze Wspólczesnej Terapii ul.
Warsaw, 02-679, Poland
Unknown Facility
Warsaw, 02-679, Poland
Gastroenterology Karolinska University Hospital Karolinska Universitetssjukhuset Gastro Centrum Medicine
Stockholm, 141 86, Sweden
Uppsala University Hospital Gastroenterology / Mag-Tarmmottagningen ingang
Uppsala, SE-751 85, Sweden
NHS Tayside
Dundee, Scotland, DD1 9SY, United Kingdom
Wansbeck General Hospital (Northumbria NHS Trust)
Ashington, NE63 9JJ, United Kingdom
University Hospital of North Durham University Hospital of North Durham Research and Development Directorate
Durham, DH1 5TW, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Unknown Facility
Tyne and Wear, NE29 8NH, United Kingdom
Related Publications (2)
Camilleri M, Lembo A, McCallum R, Tourkodimitris S, Kemps L, Miller MB, Bertelsen K, Iacob A. Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data. Aliment Pharmacol Ther. 2020 Jun;51(11):1139-1148. doi: 10.1111/apt.15711. Epub 2020 Apr 17.
PMID: 32301137DERIVEDCamilleri M, McCallum RW, Tack J, Spence SC, Gottesdiener K, Fiedorek FT. Efficacy and Safety of Relamorelin in Diabetics With Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study. Gastroenterology. 2017 Nov;153(5):1240-1250.e2. doi: 10.1053/j.gastro.2017.07.035. Epub 2017 Jul 29.
PMID: 28760384DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Wieslaw Bochenek, MD
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2015
First Posted
February 6, 2015
Study Start
January 29, 2015
Primary Completion
June 9, 2016
Study Completion
June 9, 2016
Last Updated
July 24, 2019
Results First Posted
July 24, 2019
Record last verified: 2019-06