- Blood Sugar
- Clinical Studies
- Complementary Medicine
- Diabetes and Men
- Erectile Dysfunction
- Food and Nutrition
- Insulin Pumps
- Meters and Test Strips
- Product Recalls
- Type 1
- Type 2
- Weight Loss Surgery
RM-131 Safely, Effectively Treated Symptoms in Patients with Diabetic Gastroparesis
May 8, 2014 (Healio) Patients with diabetic gastroparesis displayed increased gastric emptying and improvement in vomiting after treatment with the selective ghrelin pentapeptide relamorelin-131, according to new research presented at a late-breaking session at Digestive Disease Week.
In a phase 2 trial, researchers randomly assigned 204 patients with diabetic gastroparesis(DG) (mean age, 55.1 years; 32.3% men) into a double blind, placebo-controlled study for 28 days. Patients were enlisted to take two daily injections of relamorelin-131 10 mcg (RM-131; Rhythm) before an evening meal (n=67), RM-131 10 mcg before breakfast and an evening meal (n=68) or placebo (n=69). Patients' daily symptoms were recorded on a 0-10 scale, and a gastric emptying breath test(GEBT) was performed at baseline and on day 28.
Patients who received RM-131 before breakfast and evening meals showed accelerated GEP, the study's primary endpoint, and an improvement in vomiting (P=.033), compared with placebo patients. Results for patients who took RM-131 only before evening meals were not presented.
Post-hoc analysis of 119 patients with baseline vomiting revealed that RM-131 had a positive effect on GE, and overall weekly vomiting was reduced by 63%. This subgroup also exhibited improvements in nausea, bloating, early satiety and abdominal pain, compared with the placebo arm (P<.043). Few adverse events occurred, according to the study.
"In summary, RM-131 10 mcg twice daily showed more efficacy than once daily,"Anthony Lembo, MD, gastroenterologist at Beth Israel Deaconess Medical Center, Boston, said at the conference. "In post-hoc analysis in the subgroup of patients, RM-131 10 mcg twice daily is effective in all endpoints. There were no safety concerns seen in the studies." - by Melinda Stevens