Current partner codePEPTIDESDE
NCT01394055·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

20

Locations

1

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

RM-131

100 μg subcutaneously once

DRUG

Placebo

Matching placebo volume subcutaneously once

Timeline

From registration to results.

  1. First posted

    Jul 14, 2011

  2. Study start

    Jul 2011

  3. Primary completion

    Nov 2012

  4. Study completion

    Dec 2012

  5. Results posted

    Not reported

  6. Registry updated

    Sep 22, 2016

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
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.

Study locations

1 registered sites.

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

Mayo Clinic

Rochester, Minnesota, United States

Related trials

More studies on Relamorelin.

Related PeptideStat pages

Put the record in context.

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