A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

Allergan

Status and phase: Terminated; Phase 3

Conditions: Gastroparesis; Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Relamorelin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03285308

2017-002136-16 (EudraCT Number)

RLM-MD-01

Details and patient eligibility

About

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

Enrollment: 336 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Type 1 or Type 2 diabetes mellitus
• Meet the per protocol criteria of diabetic gastroparesis
• Compliance with diary
• Compliance with the per protocol study treatment dosing instructions

Exclusion criteria

• 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
• History of gastrointestinal disorders that may be similar to gastroparesis
• Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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336 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Relamorelin 10 μg

Experimental group

Description:

Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Treatment:

Drug: Relamorelin