Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
1 other identifier
interventional
204
1 country
30
Brief Summary
The purpose of this study is to evaluate the effects of RM-131 on gastric emptying, gastroparesis symptoms, and the safety and tolerability of RM-131 compared to placebo in patients with Type 1 and Type 2 diabetes mellitus and gastroparesis. The study is designed to evaluate the efficacy and safety of multiple dose regimens of RM-131. Study drug (RM-131 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 Apr 2012
30 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
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 2, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 23, 2016
September 1, 2016
1.3 years
April 2, 2012
September 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of RM-131 on gastric emptying time
Change from baseline in gastric half-emptying time (t½)
Screening and Day 28
Secondary Outcomes (2)
Effect of RM-131 on symptoms of gastroparesis
Baseline, daily for 28 days, and Day 35
Safety and tolerability of RM-131
From Screening through Day 35
Study Arms (2)
RM-131
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures.
- Type 1 or Type 2 diabetes mellitus with HbA1c ≤11% at screening.
- Diabetic gastroparesis defined as at least 3 months history of symptoms suggestive of gastroparesis on an ongoing basis.
- Average Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) \> 2.6 during Visit 2.
- History of nausea and/or vomiting/emesis at least once a week during the 2 weeks prior to Visit 1.
- Delayed gastric emptying confirmed at screening by abnormal gastric emptying breath test (GEBT), defined as half-emptying time (t½) \> 79 minutes.
- Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to Visit 2.
- No use of metoclopramide, erythromycin or anti-emetics for at least 2 weeks prior to Visit 2.
- Body mass index \> 18 kg/m2.
- Female patients must have negative serum or urine pregnancy tests and must not be 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 \[defined as a minimum of one year since the last menstrual period\]). Post-menopausal status will be confirmed by FSH.
You may not qualify if:
- Currently receiving parenteral feeding; presence of a nasogastric or other enteral tube for feeding or decompression.
- History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure.
- History of pyloric injection of botulinum toxin within 6 months of screening.
- Persistent daily vomiting.
- Patients with clinical suspicion of upper gastrointestinal obstruction must have been evaluated per standard of care, and obstruction ruled out before screening.
- Currently taking opiates.
- Currently taking GLP-1 and amylin analogs.
- Allergic or intolerant of egg, wheat, milk or algae, as these are components of the GEBT study meal.
- History of anorexia nervosa, binge-eating or bulimia within 5 years.
- ALT or AST \> 2 X upper limit of normal during screening.
- 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 which are likely to impact compliance with protocol requirements.
- Poor venous access or inability to tolerate venipuncture.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Dothan, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
North Little Rock, Arkansas, United States
Unknown Facility
Concord, California, United States
Unknown Facility
Lomita, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Inverness, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Monroe, Louisiana, United States
Unknown Facility
Chevy Chase, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Farmington Hills, Michigan, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Lebanon, New Hampshire, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Morehead City, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Wilmington, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Chattanooga, Tennessee, United States
Unknown Facility
Germantown, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Lubbock, Texas, United States
Unknown Facility
Burke, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
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: 32301137DERIVEDLembo A, Camilleri M, McCallum R, Sastre R, Breton C, Spence S, White J, Currie M, Gottesdiener K, Stoner E; RM-131-004 Trial Group. Relamorelin Reduces Vomiting Frequency and Severity and Accelerates Gastric Emptying in Adults With Diabetic Gastroparesis. Gastroenterology. 2016 Jul;151(1):87-96.e6. doi: 10.1053/j.gastro.2016.03.038. Epub 2016 Apr 4.
PMID: 27055601DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chief Development Officer
Rhythm Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2012
First Posted
April 5, 2012
Study Start
April 1, 2012
Primary Completion
August 1, 2013
Study Completion
September 1, 2013
Last Updated
September 23, 2016
Record last verified: 2016-09