Clinical trial NCT01394055: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Motus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pharmacodynamic (PD) effects of RM-131 on gastric emptying
timeFrame: 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 outcomes:
measure: Safety and tolerability of RM-131
timeFrame: Day 1 and 2 after dosing in Period 1 and Day 1 and 2 after dosing in Period 2
measure: Pharmacokinetics (PK) of RM-131
timeFrame: 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
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.