DRUG
RM-131
100 μg subcutaneously once
Status
Completed
Phase
Phase 1
Enrollment
20
Locations
1
Results
Not posted
Publications
2
Study 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.
Interventions
DRUG
100 μg subcutaneously once
DRUG
Matching placebo volume subcutaneously once
Timeline
First posted
Jul 14, 2011
Study start
Jul 2011
Primary completion
Nov 2012
Study completion
Dec 2012
Results posted
Not reported
Registry updated
Sep 22, 2016
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)
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
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
United States. Showing up to 24 locations stored in the fast local snapshot.
Mayo Clinic
Rochester, Minnesota, United States
Publications
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