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Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT02357420•Allergan

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+2 more criteria

Exclusion Criteria

•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 gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure. (A history of diagnostic endoscopy is not exclusionary.)
•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.
+6 more criteria

Locations (98)

Digestive Health Specialist of the Southeast

Dothan, Alabama, United States

Huntsville, Alabama, United States

Desert Sun Clinical Research

Tucson, Arizona, United States

Adobe Clinical Research

Tucson, Arizona, United States

Harrisburg Family Medical Center

Harrisburg, Arkansas, United States

Arkansas Primary Care Clinic

Little Rock, Arkansas, United States

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

TriWest Research Associates

El Cajon, California, United States

Torrance Clinical Research Institute Inc.

Lomita, California, United States

Axis Clinical Trials

Los Angeles, California, United States

Key Dates

Start Date

January 29, 2015

Primary Completion Date

June 9, 2016

Completion Date

June 9, 2016

Last Updated

July 24, 2019

Enrollment

393

ACTUAL participants

Conditions

Diabetes MellitusDiabetes Mellitus ComplicationsGastroparesis

Interventions

Relamorelin

DRUG

Placebo

DRUG

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

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RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

Inclusion Criteria

Exclusion Criteria

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