Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01394055
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : September 22, 2016
Information provided by (Responsible Party):
Motus Therapeutics, Inc.

Brief Summary:
The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and delayed gastric emptying.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 and 2 Diabetes Mellitus Complications Gastroparesis Gastrointestinal Motility Disorder Drug: RM-131 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose, 2-Period Crossover Study to Evaluate the Pharmacodynamics of RM-131 Administered to Patients With Diabetic Gastroparesis
Study Start Date : July 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: RM-131 Drug: RM-131
100 μg subcutaneously once

Placebo Comparator: Placebo Drug: Placebo
Matching placebo volume subcutaneously once

Primary Outcome Measures :
  1. Pharmacodynamic (PD) effects of RM-131 on gastric emptying [ Time Frame: Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2 ]
    Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids)

Secondary Outcome Measures :
  1. Safety and tolerability of RM-131 [ Time Frame: Day 1 and 2 after dosing in Period 1 and Day 1 and 2 after dosing in Period 2 ]
    Number of participants with adverse events

  2. Pharmacokinetics (PK) of RM-131 [ Time Frame: Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2 ]
    Median T-max of RM-131 levels in patients with type 2 diabetes mellitus

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Able to provide written informed consent prior to any study procedures.
  • Diagnosis of Type 1 or 2 diabetic gastroparesis.
  • Controlled Type 1 or 2 diabetes mellitus (HbA1c <10.1%).
  • Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to Period 1 (daily adjustments of insulin doses are permitted).
  • Body mass index of 18-40 kg/m².

Key Exclusion Criteria:

  • Unable or unwilling to provide informed consent or to comply with study procedures.
  • History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure. (Note: history of diagnostic endoscopy is not exclusionary).
  • Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, poor renal or hepatic function, etc.
  • Any clinically significant abnormalities on screening laboratories as determined by the Investigator.
  • Abnormal 12-lead electrocardiogram (ECG), including evidence of acute myocardial or subendocardial ischemia and clinically significant arrhythmias or conduction abnormalities or blood pressure at screening except minor deviations deemed to be of no clinical significance by the Investigator.
  • Poor venous access or inability to tolerate venipuncture.
  • Acute GI illness within 48 hours of Period 1.
  • Positive pregnancy test.
  • 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, would confound proper interpretation of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01394055

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Motus Therapeutics, Inc.
Principal Investigator: Michael Camilleri, MD Mayo Clinic

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Motus Therapeutics, Inc. Identifier: NCT01394055     History of Changes
Other Study ID Numbers: RM-131-003
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Motus Therapeutics, Inc.:
Diabetes Mellitus Type 1 and 2
Delayed Gastric Emptying
Gastrointestinal Motility Disorder

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms
Autoimmune Diseases
Immune System Diseases