Last updated on December 2019

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetes Mellitus | Gastroparesis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Two different groups of participants may enter into the study:
  • Participants must meet all the inclusion criteria at screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) (including compliance with dosing,entry of diary data into the DGSSD during the lead-in study Run-in Period). Participants are eligible for randomization into Study RLM-MD-04 if:
  • 1) They had no vomiting episodes recorded in the DGSSD and had an average daily DGSSS 12 at the end of the lead-in study Run-in Period.

OR

  • 2) They had vomiting episodes recorded in the DGSSD but had an average daily DGSSS of 12 and < 16 at the end of the lead-in study Run-in Period.

In the current study, these "rollover participants" will enter the study at Visit 1 (Randomization); they will not undergo Screening (Visit -2) or the Run-in Visit (Visit -1) procedures

Patients who undergo screening and run-in procedures in Study RLM-MD-04 are "de novo participants". To be eligible for randomization in the current study, de novo participants must meet all Screening and Run-in Period criteria for Study RLM-MD-04, including:

  1. At Screening, be male or female age 18 years and older, T1DM or T2DM with controlled and stable blood glucose levels and HbA1c 11%; symptoms suggestive of DG for at least 3 months (one of which must be nausea), with mechanical obstruction of the GI tract as the cause of symptoms having been ruled out;
  2. After Run-in Period: Evidence of compliance during the Run-in Period with the use of the electronic hand-held device for entry of data, with twice daily SC injections of the study treatment, and no treatment with GI promotility agents; a score of 12 for the average of the daily DGSSS measured during the Run-in Period, delayed GE by gastric emptying breath test (GEBT).

Exclusion Criteria:

  • Participants with a know allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
  • Rollover participants will be excluded from this study if any of the lead-in study exclusion criteria apply at Screening and at the end of the Run-in Period for randomization into the Treatment Period of the study

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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