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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
  • Drug: Placebo
    Placebo injected subcutaneously twice daily.
Experimental
Relamorelin 10 μg 		Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
  • Drug: Relamorelin
    Relamorelin 10 micrograms (μg) injected subcutaneously twice daily.

More Details

Status
Terminated
Sponsor
Allergan

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.