Conditions: Diabetes Mellitus Diabetes Mellitus Complications Gastroparesis
Keywords: Diabetes Mellitus Delayed Gastric Emptying Vomiting Gastroparesis Gastrointestinal Motility Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 393
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Relamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks. arm 2: Relamorelin 30 μg was administered SC by injection BID for 12 weeks. arm 3: Relamorelin 100 μg was administered SC by injection BID for 12 weeks. arm 4: Placebo-matching relamorelin was administered SC by injection BID for 12 weeks.

Interventions: intervention 1: Relamorelin intervention 2: Placebo
Intervention descriptions: intervention 1: Double blind relamorelin was given subcutaneously BID for 12 weeks. intervention 2: Placebo given subcutaneously for 12 weeks.

Protocol document: