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

Primary Purpose

Diabetes Mellitus Type 1 and 2, Diabetes Mellitus Complications, Gastroparesis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RM-131

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 1 and 2 focused on measuring Diabetes Mellitus Type 1 and 2, Delayed Gastric Emptying, Gastroparesis, Gastrointestinal Motility Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RM-131

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Safety and tolerability of RM-131

Number of participants with adverse events

Pharmacokinetics (PK) of RM-131

Median T-max of RM-131 levels in patients with type 2 diabetes mellitus

Full Information

NCT ID

NCT01394055

First Posted

July 8, 2011

Last Updated

September 21, 2016

Sponsor

Motus Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01394055

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Motus Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RM-131

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

RM-131

Intervention Description

100 μg subcutaneously once

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo volume subcutaneously once

Primary Outcome Measure Information:

Title

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

Description

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

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

Secondary Outcome Measure Information:

Title

Safety and tolerability of RM-131

Description

Number of participants with adverse events

Time Frame

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

Title

Pharmacokinetics (PK) of RM-131

Description

Median T-max of RM-131 levels in patients with type 2 diabetes mellitus

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Camilleri, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23639598

Citation

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.

Results Reference

derived

PubMed Identifier

22961573

Citation

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.

Results Reference

derived

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

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