Efficacy and Safety of Relamorelin in Diabetics with Symptoms of Gastroparesis:A Randomized, Placebo-Controlled Study.

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Efficacy and Safety of Relamorelin in Diabetics with Symptoms of Gastroparesis:A Randomized, Placebo-Controlled Study.

Gastroenterology. 2017 Jul 28;:

Authors: Camilleri M, McCallum RW, Tack J, Spence SC, Gottesdiener K, Fiedorek FT

BACKGROUND & AIMS: Gastroparesis is a complication of diabetes with few treatment options. Relamorelin (also called RM-131) is a selective, prokinetic agonist of ghrelin. We aimed to evaluate efficacy of relamorelin on symptoms and gastric emptying (GE) in a 12-week, phase 2B study of diabetic patients with moderate to severe gastroparesis symptoms (DG).
METHODS: We performed a study of 393 patients with DG (37.7% male; 9.9% with type 1 diabetes; median age, 58.2 years [range 20-76]; median body mass index, 31.4 kg/m2 [range, 18.2-60.1]; HbA1c level, 7.6%, [range, 5.2 -11.0]). All participants had (13)C-spirulina GE breath test T1/2 values of 79 min or more (with 89.8% delayed relative to 90(th) %ile of normal, 85.75 minutes), recent vomiting, and gastroparesis cardinal symptom index-daily diary scores of 2.6 or more. Patients were randomly assigned to groups given placebo (n=104) or relamorelin (10 μg [n=98], 30 μg [n=109], or 100 μg [n=82] twice daily) for 12 weeks, following a 2-week, single-blind, placebo run-in period. Patient-reported outcomes were determined from DG Symptom Severity daily e-diaries, in which patients recorded vomiting frequency and symptom scores (nausea, abdominal pain, postprandial fullness, and bloating) on a 0-10 scale. Endpoints were change from baseline in vomiting frequency, composite DG Symptom Severity score, GE, and safety. We performed longitudinal, mixed-effects model analysis using repeated measures, with baseline and baseline-by-week interaction values as covariates.
RESULTS: Patients given relamorelin had a 75% reduction in vomiting frequency compared to baseline, but this difference was not significant compared with the placebo group. All 4 symptoms of DG (composite or individual symptoms) were significantly reduced over the 12-week study period in all 3 relamorelin dose groups, compared to the placebo group (all P<.05, based on longitudinal analysis over 12 weeks). Relamorelin significantly accelerated GE from baseline compared with placebo (by 12%, P<.05 for the 10 and 30 μg groups; P=.051 for the 100 μg group). Dose-related worsening of glycemic control was noted in 14.5% of patients who received relamorelin; some required insulin or other diabetes drug dosage adjustments.
CONCLUSIONS: In a phase 2B randomized trial of patients with moderate to severe DG, relamorelin significantly reduced core symptoms of DG and overall composite score compared to placebo, accelerated GE, and was generally safe and well tolerated.

PMID: 28760384 [PubMed - as supplied by publisher]

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