NCT02357420

Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 393 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1 and Type 2 diabetes mellitus and gastroparesis. Study drug (relamorelin and placebo) will be administered subcutaneously in a blinded fashion.

Conditions

• Diabetes Mellitus
• Diabetes Mellitus Complications
• Gastroparesis

Interventions

Type	Name	Description
DRUG	Relamorelin	Double blind relamorelin was given subcutaneously BID for 12 weeks.
DRUG	Placebo	Placebo given subcutaneously for 12 weeks.

Timeline

• Start date: 2015-01-29
• Primary completion: 2016-06-09
• Completion: 2016-06-09
• First posted: 2015-02-06
• Last updated: 2019-07-24
• Results posted: 2019-07-24

Locations

98 sites across 7 countries: United States, Belgium, Germany, Israel, Poland, Sweden, United Kingdom