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

NCT01394055 | Completed Phase 1

• 1 other identifier: RM-131-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 1 and 2; Diabetes Mellitus Complications; Gastroparesis; Gastrointestinal Motility Disorder

Keywords

Diabetes Mellitus Type 1 and 2; Delayed Gastric Emptying; Gastroparesis; Gastrointestinal Motility Disorder

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamic (PD) effects of RM-131 on gastric emptying

  Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids)

  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

Secondary Outcomes (2)

• Safety and tolerability of RM-131

  Day 1 and 2 after dosing in Period 1 and Day 1 and 2 after dosing in Period 2

• Pharmacokinetics (PK) of RM-131

  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

Study Arms (2)

RM-131

ACTIVE COMPARATOR

Drug: RM-131

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

RM-131 DRUG

100 μg subcutaneously once

RM-131

Placebo DRUG

Matching placebo volume subcutaneously once

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Unable or unwilling to provide informed consent or to comply with study procedures.
• 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.

Sponsors & Collaborators

• Motus Therapeutics, Inc.: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Shin A, Camilleri M, Busciglio I, Burton D, Smith SA, Vella A, Ryks M, Rhoten D, Zinsmeister AR. The ghrelin agonist RM-131 accelerates gastric emptying of solids and reduces symptoms in patients with type 1 diabetes mellitus. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1453-1459.e4. doi: 10.1016/j.cgh.2013.04.019. Epub 2013 Apr 30.

  PMID: 23639598 DERIVED

• Shin A, Camilleri M, Busciglio I, Burton D, Stoner E, Noonan P, Gottesdiener K, Smith SA, Vella A, Zinsmeister AR. Randomized controlled phase Ib study of ghrelin agonist, RM-131, in type 2 diabetic women with delayed gastric emptying: pharmacokinetics and pharmacodynamics. Diabetes Care. 2013 Jan;36(1):41-8. doi: 10.2337/dc12-1128. Epub 2012 Sep 6.

  PMID: 22961573 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Complications; Gastroparesis

Interventions

relamorelin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 14, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

US (1)