A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of Relamorelin compared to placebo in patients with diabetic gastroparesis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Brian Lacy, M.D., Ph.D.

Contact us for the latest status

Contact information:

Frances Cayer CCRP

Cayer.Frances@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20482107

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