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

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)
during the lead-in study Run-in Period at the end of the lead-in study Run-in Period,
are eligible for randomization in 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, with BMI > 18.5 kg/m2; 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; delayed GE
by gastric emptying breath test (GEBT).

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.

Exclusion Criteria:

- There are no exclusion criteria specific to this study; participants will be excluded
from this study if any of the exclusion criteria apply at screening (Visit 1) and at
the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of
studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria