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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RM-131

Group Type ACTIVE_COMPARATOR

RM-131

Intervention Type DRUG

100 μg subcutaneously once

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo volume subcutaneously once

Interventions

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RM-131

100 μg subcutaneously once

Intervention Type DRUG

Placebo

Matching placebo volume subcutaneously once

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No