A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

• ClinicalTrials.gov Identifier: NCT03285308
• Recruitment Status: Terminated
• First Posted: September 18, 2017
• Results First Posted: July 29, 2021
• Last Update Posted: July 29, 2021
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Tracking Information

• First Submitted Date: September 14, 2017
• First Posted Date: September 18, 2017
• Results First Submitted Date: July 8, 2021
• Results First Posted Date: July 29, 2021
• Last Update Posted Date: July 29, 2021
• Actual Study Start Date: September 29, 2017
• Actual Primary Completion Date: July 8, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 8, 2021)

• Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) [ Time Frame: Baseline (Day-14 to Day-1) to Week 12 ]
  Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the Run-in Period.
• Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Week 6 to Week 12 ]
  The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.

Original Primary Outcome Measures (submitted: September 14, 2017)

Percentage of patients meeting the diabetic gastroparesis symptom responder criterion in each of the last 6 of the 12 weeks of treatment [ Time Frame: Baseline, 12 Weeks ]

Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.

Current Secondary Outcome Measures (submitted: July 8, 2021)

• Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
  A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea.
• Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
  An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary.
• Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
  A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary.
• Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [ Time Frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12) ]
  A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst).
• Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Up to approximately 16 weeks ]
  An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
• Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results [ Time Frame: Up to 12 weeks ]
  Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
• Number of Participants With Clinically Meaningful Trends for Vital Signs [ Time Frame: Up to 12 weeks ]
  Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant.
• Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results [ Time Frame: Up to 12 weeks ]
  A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
• Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) [ Time Frame: Baseline (Day 1) up to 12 weeks ]
  HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound.
• Number of Participants With Anti-relamorelin Antibody Testing Results by Visit [ Time Frame: Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84) ]
  A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.

Original Secondary Outcome Measures (submitted: September 14, 2017)

Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment [ Time Frame: 12 Weeks ]

Vomiting episodes will be patient-recorded daily using an electronic diary.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
• Official Title: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
• Brief Summary: This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Gastroparesis
• Diabetes Mellitus

Intervention

• Drug: Placebo
  Placebo injected subcutaneously twice daily.
• Drug: Relamorelin
  Relamorelin 10 micrograms (μg) injected subcutaneously twice daily.

Study Arms

• Placebo Comparator: Placebo
  Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
  Intervention: Drug: Placebo
• Experimental: Relamorelin 10 μg
  Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
  Intervention: Drug: Relamorelin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 30, 2020): 336
• Original Estimated Enrollment (submitted: September 14, 2017): 600
• Actual Study Completion Date: July 8, 2020
• Actual Primary Completion Date: July 8, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Bulgaria, France, India, Israel, Korea, Republic of, Malaysia, Philippines, Poland, Singapore, Spain, Thailand, Ukraine, United States
• Removed Location Countries: Italy, Saudi Arabia

Administrative Information

• NCT Number: NCT03285308
• Other Study ID Numbers: RLM-MD-01; 2017-002136-16 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Allergan
• Original Responsible Party: Same as current
• Current Study Sponsor: Allergan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Wieslaw (Wes) Bochenek, MD, PhD; Allergan

• PRS Account: Allergan
• Verification Date: July 2021