Current partner codePEPTIDESDE
NCT01571297·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

204

Locations

30

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

RM-131

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

DRUG

Placebo

Placebo given subcutaneously for 35 days

Timeline

From registration to results.

  1. First posted

    Apr 5, 2012

  2. Study start

    Apr 2012

  3. Primary completion

    Aug 2013

  4. Study completion

    Sep 2013

  5. Results posted

    Not reported

  6. Registry updated

    Sep 23, 2016

Outcomes

What the study measures.

Primary outcomes

Effect of RM-131 on gastric emptying time

Time frame · Screening and Day 28

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

Secondary outcomes

Effect of RM-131 on symptoms of gastroparesis

Time frame · Baseline, daily for 28 days, and Day 35

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

Safety and tolerability of RM-131

Time frame · From Screening through Day 35

Assessment of adverse events and clinical laboratory evaluations

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

30 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Facility not named

Dothan, Alabama, United States

Facility not named

Tucson, Arizona, United States

Facility not named

North Little Rock, Arkansas, United States

Facility not named

Concord, California, United States

Facility not named

Lomita, California, United States

Facility not named

Los Angeles, California, United States

Facility not named

Torrance, California, United States

Facility not named

Hialeah, Florida, United States

Facility not named

Inverness, Florida, United States

Facility not named

Miami, Florida, United States

Facility not named

West Palm Beach, Florida, United States

Facility not named

Wichita, Kansas, United States

Facility not named

Monroe, Louisiana, United States

Facility not named

Chevy Chase, Maryland, United States

Facility not named

Boston, Massachusetts, United States

Facility not named

Farmington Hills, Michigan, United States

Facility not named

Jackson, Mississippi, United States

Facility not named

Lebanon, New Hampshire, United States

Facility not named

Albuquerque, New Mexico, United States

Facility not named

Morehead City, North Carolina, United States

Facility not named

Raleigh, North Carolina, United States

Facility not named

Wilmington, North Carolina, United States

Facility not named

Winston-Salem, North Carolina, United States

Facility not named

Portland, Oregon, United States

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.