Diabetes Mellitus Complications, Diabetes Mellitus Type 1 and 2, Gastrointestinal Motility Disorder, Gastroparesis
Conditions
Keywords
Diabetes Mellitus Type 1 and 2, Delayed Gastric Emptying, Gastroparesis, Gastrointestinal Motility Disorder
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.
Interventions
DRUGRM-131
100 μg subcutaneously once
DRUGPlacebo
Matching placebo volume subcutaneously once
Sponsors
Motus Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic (PD) effects of RM-131 on gastric emptying | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of RM-131 | 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 | 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 |
Countries
United States
Outcome results
None listed