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Diabetes MellitusPhase 2NCT01571297

Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis

A Phase 2 study testing RM-131 in people with Diabetes Mellitus and Diabetes Mellitus Complications, run by Motus Therapeutics, Inc. at 30 sites in United States.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
RM-131
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
30 sitesUnited States
Study dates
Apr 2012to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Boston, Massachusetts

  • Study site

    Burke, Virginia

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chevy Chase, Maryland

  • Study site

    Concord, California

  • Study site

    Dallas, Texas

  • Study site

    Dothan, Alabama

  • Study site

    Farmington Hills, Michigan

  • Study site

    Germantown, Tennessee

  • Study site

    Hialeah, Florida

  • Study site

    Inverness, Florida

  • Study site

    Jackson, Mississippi

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lomita, California

  • Study site

    Los Angeles, California

  • Study site

    Lubbock, Texas

  • Study site

    Miami, Florida

  • Study site

    Monroe, Louisiana

  • Study site

    Morehead City, North Carolina

  • Study site

    Norfolk, Virginia

  • Study site

    North Little Rock, Arkansas

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Torrance, California

  • Study site

    Tucson, Arizona

  • Study site

    West Palm Beach, Florida

  • Study site

    Wichita, Kansas

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

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

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.

Being tested
RM-131, Placebo
Keywords
Diabetes Mellitus, Delayed Gastric Emptying, Gastroparesis, Gastrointestinal Motility Disorder
Medical subject headings
Diabetes Mellitus, Diabetes Complications, Gastroparesis

What participants receive

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

  • RM-131Drug

    Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.

  • PlaceboDrug

    Placebo given subcutaneously for 35 days

Study groups in NCT01571297
Study groupRoleWhat they receive
RM-131Active comparatorNot described
Receives: Drug: RM-131
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Effect of RM-131 on gastric emptying time

    Change from baseline in gastric half-emptying time (t½)

    Measured: Screening and Day 28

Secondary outcomes (2)

  1. Effect of RM-131 on symptoms of gastroparesis

    Longitudinal change from baseline over time in daily symptom scores from a self administered daily symptom diary

    Measured: Baseline, daily for 28 days, and Day 35

  2. Safety and tolerability of RM-131

    Assessment of adverse events and clinical laboratory evaluations

    Measured: From Screening through Day 35

Timeline

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

  1. First posted5 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2013
  4. Study completionSep 2013

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
Double blind
Who is masked
Participant, Investigator
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01571297
Sponsor's protocol ID
RM-131-004
Status last verified
Sep 2016
First submitted
2 Apr 2012
Last updated
23 Sep 2016
Results posted
No
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

  • 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.

    PubMed 27055601

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RM-131 in people with Diabetes Mellitus and Diabetes Mellitus Complications, run by Motus Therapeutics, Inc. at 30 sites in United States.

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 10 inclusion and 17 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Effect of RM-131 on gastric emptying time (time frame: Screening and Day 28). 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 NCT01571297, 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 23 Sep 2016.

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