Trial reportDiabetes care2013
Randomized controlled phase Ib study of ghrelin agonist, RM-131, in type 2 diabetic women with delayed gastric emptying: pharmacokinetics and pharmacodynamics.
Trial report in Diabetes care, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
49 citing papers in PubMed, 3 syntheses or guidelines pooled it, 103 citations in OpenAlex.
- Do prokinetic agents provide symptom relief through acceleration of gastric emptying? An update and revision of the existing evidence.United European gastroenterology journal · 2023Pooled it
- Efficacy and Safety of Ghrelin Agonists in Patients with Diabetic Gastroparesis: A Systematic Review and Meta-Analysis.Gut and liver · 2020Pooled it
- Pharmacological Approaches to Diabetic Gastroparesis: A systematic review of randomised clinical trials.Sultan Qaboos University medical journal · 2019Pooled it
- Trial
- Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data.Alimentary pharmacology & therapeutics · 2020Trial
- Efficacy and Safety of Relamorelin in Diabetics With Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study.Gastroenterology · 2017Trial
- Effects of ghrelin receptor agonist, relamorelin, on gastric motor functions and satiation in healthy volunteers.Neurogastroenterology and motility · 2016Trial
- Short-Term Effects of Relamorelin on Descending Colon Motility in Chronic Constipation: A Randomized, Controlled Trial.Digestive diseases and sciences · 2016Trial
- The ghrelin agonist RM-131 accelerates gastric emptying of solids and reduces symptoms in patients with type 1 diabetes mellitus.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2013Trial
- Ghrelin and relamorelin counteract hypoglycemia in mice engrafted with congenital hyperinsulinism stem cell-derived islets.Stem cells translational medicine · 2026Article
- Pharmacologic treatments for gastroparesis.Pharmacological reviews · 2025Review
- Resolution of severe gastroparesis induced by parasympathetic surge following facial trauma: a case report.Journal of medical case reports · 2024Article
- The Use of Pre-Endoscopic Metoclopramide Does Not Prevent the Need for Repeat Endoscopy: A U.S. Based Retrospective Cohort Study.Life (Basel, Switzerland) · 2024Article
- Diabetic Gastroparesis and its Emerging Therapeutic Options: A Narrative Review of the Literature.Cureus · 2023Review
- Ten controversies in gastroparesis and a look to the future.Neurogastroenterology and motility · 2023Review
- Binding Domain Characterization of Growth Hormone Secretagogue Receptor.Journal of translational internal medicine · 2022Article
- Gastroparesis.Gastroenterology · 2022Review
- Structural basis of human ghrelin receptor signaling by ghrelin and the synthetic agonist ibutamoren.Nature communications · 2021Article
- Management of Gastroparesis.Gastroenterology & hepatology · 2021Article
- New Developments in Prokinetic Therapy for Gastric Motility Disorders.Frontiers in pharmacology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveTo investigate the pharmacokinetics (PK), pharmacodynamics, and safety of single-dose RM-131 in type 2 diabetic patients with gastrointestinal cardinal symptoms (GCSI) and previously documented delayed gastric emptying (DGE). RESEARCH DESIGN AND
methodsIn a randomized crossover study, 10 female patients received RM-131 (100 μg s.c.) or placebo and underwent scintigraphic gastric emptying (GE) and colonic filling at 6 h (CF6) of a solid-liquid meal administered 30 min postdosing. Adverse events, plasma glucose, and hormonal levels were assessed. GCSI daily diary (GCSI-DD) was completed during treatments. PK was assessed in this cohort and healthy volunteers (HVs).
resultsAt screening, HbA(1c) was 7.2 ± 0.4% (SEM) and total GCSI-DD score was 1.32 ± 0.21. RM-131 accelerated GE t(1/2) of solids (P = 0.011); mean difference (Δ) in solid GE t(1/2) was 68.3 min (95% CI 20-117) or 66.1%. There were numerical differences in GE lag time, CF6 solids, and GE t(1/2) liquids (all P < 0.14). With a significant (P < 0.014) order effect, further analysis of the first treatment period (n = 5 per group) confirmed significant RM-131 effects on GE t(1/2) (solids, P = 0.016; liquids, P = 0.024; CF6, P = 0.013). PK was similar in DGE patients and HVs. There were increases in 120-min blood glucose (P = 0.07) as well as 30-90-min area under the curve (AUC) levels of growth hormone, cortisol, and prolactin (all P < 0.02) with single-dose RM-131. Only light-headedness was reported more on RM-131.
conclusionsRM-131 greatly accelerates the GE of solids in patients with type 2 diabetes and documented DGE. PK is similar in diabetic patients and HVs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.