Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

What Was Tested

In this phase 3 trial, researchers set out to test Relamorelin.

Participants will report daily severity scores of their diabetic gastroparesis symptoms.

It had two arms (groups): Placebo (placebo comparator) and one (experimental).

Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 311 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of Type 1 or Type 2 diabetes mellitus. Meet the per protocol criteria of diabetic gastroparesis. Compliance with diary.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube; actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of screening (visit 1); diagnosis of celiac disease, also a history of non-celiac gluten sensitivity.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Relamorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Relamorelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2018-02-16 with completion listed for 2020-07-16.

It ran at 240 sites in United States (114), United Kingdom (21), Canada (14), Mexico (12), Colombia (11) and Russia (11).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) (time frame: Baseline (Day-14 to Day-1) to Week 12). Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period (time frame: Week 6 to Week 12).

It also tracked 10 secondary outcomes, for example Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period, Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period, Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period, Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE), Number of Participants With Clinically Meaningful Trends for Vital Signs and Number of Participants With Anti-relamorelin Antibody Testing Results by Visit.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Relamorelin in 311 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Relamorelin compound page, all human trials.