Clinical trial NCT01571297: Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Diabetes Mellitus Complications
Gastroparesis
Keywords: Diabetes Mellitus
Delayed Gastric Emptying
Gastroparesis
Gastrointestinal Motility Disorder
Lead sponsor: Motus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Participation in a clinical study within the 30 days prior to dosing in the present study.
* Any other reason, which in the opinion of the Investigator, including renal, hepatic or cardiopulmonary disease, or significant acute ECG abnormalities that would confound proper interpretation of the study or expose a patient to unacceptable risk.

Primary outcomes:
measure: Effect of RM-131 on gastric emptying time
timeFrame: Screening and Day 28
Secondary outcomes:
measure: Effect of RM-131 on symptoms of gastroparesis
timeFrame: Baseline, daily for 28 days, and Day 35
measure: Safety and tolerability of RM-131
timeFrame: From Screening through Day 35
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: North Little Rock
country: United States
state: Arkansas
city: Concord
country: United States
state: California
city: Lomita
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Torrance
country: United States
state: California
city: Hialeah
country: United States
state: Florida
city: Inverness
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Wichita
country: United States
state: Kansas
city: Monroe
country: United States
state: Louisiana
city: Chevy Chase
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Farmington Hills
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Lebanon
country: United States
state: New Hampshire
city: Albuquerque
country: United States
state: New Mexico
city: Morehead City
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Burke
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Rhythm Pharmaceuticals, Inc.
name: Chief Development Officer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Lembo 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.