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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RM-131 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RM-131 | Drug | 100 μg subcutaneously once |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic (PD) effects of RM-131 on gastric emptying | Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of RM-131 | Number of participants with adverse events | Day 1 and 2 after dosing in Period 1 and Day 1 and 2 after dosing in Period 2 |
| Pharmacokinetics (PK) of RM-131 | Median T-max of RM-131 levels in patients with type 2 diabetes mellitus |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23639598 | Derived | 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. | |
| 22961573 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D048909 | Diabetes Complications |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000593860 | relamorelin |
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| Drug |
Matching placebo volume subcutaneously once |
|
| 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 |
| 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |