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



Status:Completed
Conditions:Gastrointestinal, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:July 2011
End Date:December 2012
Contact:NA

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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


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.


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.
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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