A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis
Intervention: Placebo; Relamorelin
Intervention description: Placebo injected subcutaneously twice daily.; Relamorelin 10 μg injected subcutaneously twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 450.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetic gastroparesis; vomiting

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.
    

Eligibility criteria:

        Inclusion Criteria:

        Two different groups of participants may enter into the study:

          1. Rollover Participants

             Participants who were not randomization-eligible at the end of the Run-in Period of
             lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be
             randomized in the study if all of the following criteria apply:

             •In the lead-in studies, participants must have met all screening visit and Run-in
             Period criteria for randomization into the Treatment Period (including compliance with
             dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary
             (DGSSD)) except that:

               -  They had zero vomiting episodes and an average daily Diabetic Gastroparesis
                  Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in
                  Period, as reported using the electronic hand-held device; OR

               -  They had vomiting episodes and an average daily DGSSS of ≥12 but <16 at the end
                  of the lead-in study Run-in Period, as reported using the electronic hand-held
                  device

          2. De Novo Participants

               -  Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5
                  years' duration, with controlled and stable blood glucose levels and hemoglobin
                  A1c (HBA1c) ≤11%

               -  DG defined as at least a 3-month history prior to Screening of symptoms (one of
                  which must be nausea) on an ongoing basis that are suggestive of gastroparesis
                  (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting,
                  and early satiety)

               -  Compliance with the entry of data into the hand-held electronic device during the
                  Run-in Period

               -  Compliance with administration of subcutaneous (SC) twice daily injections during
                  the Run-in Period

               -  The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12

        Exclusion Criteria:

          1. Both Rollover and De Novo Participants

             •Participants with a known allergy or hypersensitivity to the study treatments and
             their excipients (i.e., mannitol or phenol)

          2. Rollover Participants

             •Participants will be excluded from this study if any of the lead-in study exclusion
             criteria apply at the Screening Visit and at the end of the Run-in Period for
             randomization into the Treatment Period of studies RLM-MD-01 and RLM-MD-02, except as
             specified in the inclusion criteria

          3. De Novo Participants

               -  History of anorexia nervosa, binge-eating, bulimia, or other eating disorder
                  within 5 years of the Screening Visit

               -  History of intestinal malabsorption or pancreatic exocrine insufficiency

               -  History of belching disorders, other nausea and vomiting disorders

               -  Gastric or duodenal ulcer within 3 months of Screening

               -  History of malignancy in the 3 years prior to Screening, except for adequately
                  treated basal cell or squamous cell skin cancer, or in situ cervical cancer

               -  Currently receiving parenteral feeding or presence of a nasogastric or other
                  enteral tube for feeding or decompression

               -  Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (e.g.,
                  erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI
                  promotility agents for at least 10 days prior to the start of the Run-in Period

               -  Currently taking opiates, or expecting to use opiates during the course of the
                  clinical study

               -  Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior
                  to the start of the Run-in Period

               -  History of pyloric injection of botulinum toxin within 6 months of screening

               -  History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker
                  placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is
                  not exclusionary)

               -  Randomization in any previous study in which relamorelin was a treatment

               -  Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components
                  of the gastric emptying breath test (GEBT) study meal