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

• Status: Terminated
• Trial end date: 2020-10-05
• Target enrollment: 0
• Participant gender: All

Summary

A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan

Criteria

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