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Diabetes MellitusPhase 2NCT02357420

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

A Phase 2 study testing Relamorelin in people with Diabetes Mellitus and Diabetes Mellitus Complications, run by Allergan at 98 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Relamorelin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
393 participants
Where
98 sitesin 7 countries
Study dates
29 Jan 2015to 9 Jun 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.
  • Additional inclusion criteria for randomization after the 2-week single-blind placebo run-in period:
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

98 sites in 7 countries.

98 sites in 7 countries

United States70 sites

  • Study site

    Ann Arbor, Michigan, 48109

  • River Birch Research Alliance LLC

    Blue Ridge, Georgia, 30513

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • ClinSearch LLC

    Chattanooga, Tennessee, 37421

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Khan and Abbasi Research

    Chester, Virginia, 23831

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Metropolitan Gastroenterology Group, P.C. (Chevy Chase Clinical Research) Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • Danbury Hospital- Office of Clinical trials

    Danbury, Connecticut, 06810

  • Avail Clinical Research

    DeLand, Florida, 32720

  • Digestive Health Specialist of the Southeast

    Dothan, Alabama, 36305

  • TriWest Research Associates

    El Cajon, California, 92020

  • Study site

    El Paso, Texas, 79905

  • Medisphere Medical Research Center

    Evansville, Indiana, 47714

  • Detroit Clinical Research Center, PC-Farmington Hills

    Farmington Hills, Michigan, 48334

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Study site

    Great Neck, New York, 11023

  • Harrisburg Family Medical Center

    Harrisburg, Arkansas, 72432

  • International Research Associates LLC

    Hialeah, Florida, 33012

  • GI Specialists of Houston

    Houston, Texas, 77015

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • The University of Texas Health Science Center & Medical School at Houston

    Houston, Texas, 77030

  • Study site

    Huntsville, Alabama, 35801

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Impact Clinical Trials

    Las Vegas, Nevada, 89106

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • MetroHealth Medical Center

    Leveland, Ohio, 44109

  • OnSite Clinical Solutions- Lexington OnSite Clinical Solutions, LLC

    Lexington, North Carolina, 27292

  • Arkansas Primary Care Clinic

    Little Rock, Arkansas, 72204

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211

  • Torrance Clinical Research Institute Inc.

    Lomita, California, 90717

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • University of Louisville

    Louisville, Kentucky, 40202

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • Great Lakes Gastroenterology Research

    Mentor, Ohio, 44060

  • APF Research, LLC

    Miami, Florida, 33135

  • Advanced Pharma CR, LLC

    Miami, Florida, 33136

  • Baptist Diabetes Associates, P.A.

    Miami, Florida, 33156

  • Study site

    Miami, Florida, 33175

  • International Research Associates LLC

    Miami, Florida, 33183

  • Delta Research Partners

    Monroe, Louisiana, 71201

  • Diabetes and Endocrinology Consultants, P.C.

    Morehead City, North Carolina, 28557

  • Family Medicine of SayeBrook

    Myrtle Beach, South Carolina, 29588

  • Advanced Research Institute Inc

    New Port Richey, Florida, 34655

  • New York Clinical Trials, Inc

    New York, New York, 10018

  • Aspen Clinical Research

    Orem, Utah, 84058

  • Planters Clinic

    Port Gibson, Mississippi, 39150

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Northwest Gastroenterology Clinic

    Portland, Oregon, 97210

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • ZainResearch, LLC

    Richland, Washington, 99352

  • Healing Hands of Virginia LLC

    Richmond, Virginia, 23225

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois, 61107

  • Highland Clinical Research

    Salt Lake City, Utah, 84095

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • OnSite Clinical Solutions, LLC

    Statesville, North Carolina, 28117

  • Gulf Coast Medical Research, LLC

    Sugar Land, Texas, 77478

  • Center For Digestive Health

    Troy, Michigan, 48098

  • Desert Sun Clinical Research

    Tucson, Arizona, 85710

  • Adobe Clinical Research

    Tucson, Arizona, 85712

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Gastroenterology Consultants

    Virginia Beach, Virginia, 23455

  • Clinical Trials of America LA, LLC

    West Monroe, Louisiana, 71291

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Professional Research Network of Kansas, LLC

    Wichita, Kansas, 67203

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

  • Wake Forest University Baptist Health - Dept of Gastroenterology Medical Center Blvd

    Winston-Salem, North Carolina, 27107

Other trials in United States

Poland8 sites

  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J. ul.

    Bialystok, 15-879

  • NZOZ Witamed al.

    Kielce, 25-035

  • CenterMed Krakow

    Krakow, 31530

  • Gabinet Lekarski dr n.med. Malgorzata Saryusz-Wolska ul.

    Lodz, 90-132

  • NZOZ Pulsmedica ul.

    Lodz, 93-509

  • KO-MED Centra Kliniczne

    Staszów, 28-200

  • Centrum Badawcze Wspólczesnej Terapii ul.

    Warsaw, 02-679

  • Study site

    Warsaw, 02-679

Other trials in Poland

United Kingdom7 sites

  • Wansbeck General Hospital (Northumbria NHS Trust)

    Ashington, NE63 9JJ

  • NHS Tayside

    Dundee, Scotland, DD1 9SY

  • University Hospital of North Durham University Hospital of North Durham Research and Development Directorate

    Durham, DH1 5TW

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • King's College Hospital

    London, SE5 9RS

  • The James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Study site

    Tyne and Wear, NE29 8NH

Other trials in United Kingdom

Germany5 sites

  • Herz und Diabeteszentrum Nordrhein Westfalen, Universitätsklinikum der Ruhr-Universiät Bochum

    Bad Oeynhausen, 32545

  • Praxis Dr. Ott Rabenauer Str.

    Dippoldiswalde, 01744

  • GWT-TUD GmbH

    Dresden, 01307

  • Israelitisches Krankenhaus Orchideenstig

    Hamburg, 22297

  • Diabetes Zentrum und Praxis Prof. Pfützner Parcusstr.

    Mainz, 55116

Other trials in Germany

Israel4 sites

  • Rambam Health Care Campus - Inst. of Endocrinology, Diabetes, and Metabolism

    Haifa, 31096

  • Wolfson Medical Center

    Holon, 58100

  • Rabin Medical Center, Beilinson Hospital Gastroenterology Dept

    Petah Tikva, 49100

  • ZIV Medical Center

    Safed, 13100

Other trials in Israel

Belgium2 sites

  • Hopital Erasme - Universite Libre de Bruxelles

    Brussels, 1070

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Sweden2 sites

  • Gastroenterology Karolinska University Hospital Karolinska Universitetssjukhuset Gastro Centrum Medicine

    Stockholm, 141 86

  • Uppsala University Hospital Gastroenterology / Mag-Tarmmottagningen ingang

    Uppsala, SE-751 85

Other trials in Sweden

About this study

Official title: 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

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.

Being tested
Relamorelin, Placebo
Keywords
Diabetes Mellitus, Delayed Gastric Emptying, Vomiting, Gastroparesis, Gastrointestinal Motility Disorder
Medical subject headings
Diabetes Mellitus, Diabetes Complications, Gastroparesis, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelamorelinDrug

    Also called RM-131

    Double blind relamorelin was given subcutaneously BID for 12 weeks.

  • PlaceboDrug

    Placebo given subcutaneously for 12 weeks.

Study groups in NCT02357420
Study groupRoleWhat they receive
Relamorelin 10 μgExperimentalRelamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
Receives: Drug: Relamorelin
Relamorelin 30 μgExperimentalRelamorelin 30 μg was administered SC by injection BID for 12 weeks.
Receives: Drug: Relamorelin
Relamorelin 100 μgExperimentalRelamorelin 100 μg was administered SC by injection BID for 12 weeks.
Receives: Drug: Relamorelin
PlaceboPlacebo comparatorPlacebo-matching relamorelin was administered SC by injection BID for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7 days prior to Day 1 for Baseline to 7 days prior to Week 12

Secondary outcomes (2)

  1. Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)

    The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of DG (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Severity of nausea, bloating and abdominal pain, were assessed on a numerical rating scale of 0 to 10, with 0 equating to "no" (symptom) and 10 equating to "worst possible" (symptom). Early satiety was assessed on a 5-item scale with 1 being "Only 1 or 2 bites" and 5 being "All of a normal-sized meal"; symptom severity scores for this item were reversed and normalized to a range 0 to 10 for the development of the DGSSD 4-symptom Composite Score. The DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal pain) range is 0 to 40. Higher scores indicate worse condition. Weekly scores were averaged across 12 weeks period. A negative change from Baseline indicates improvement.

    Measured: 7 days prior to Day 1 for Baseline to 7 days prior to Week 12

  2. Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time

    GE was measured via the GEBT and was reported as a time to half (t1/2) of the theoretical total GE. GEBT is a non-radioactive stable isotope breath test intended for measurement of GE of solids in participants. A negative change from Baseline indicates improvement.

    Measured: Baseline (Day 1) to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2015 (estimated)
  2. Study start29 Jan 2015
  3. Primary completion9 Jun 2016
  4. Study completion9 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02357420
Sponsor's protocol ID
RM-131-009
Other IDs
2014-005623-27, 2014
Status last verified
Jun 2019
First submitted
29 Jan 2015
Last updated
24 Jul 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 32301137

  • Camilleri 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.

    PubMed 28760384

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Relamorelin in people with Diabetes Mellitus and Diabetes Mellitus Complications, run by Allergan at 98 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, Poland, United Kingdom, Germany, Israel and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 12 in Weekly Vomiting Episodes (time frame: 7 days prior to Day 1 for Baseline to 7 days prior to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02357420, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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