A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

Phase 3

Terminated

• Conditions: Gastroparesis; Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Relamorelin

• Registration Number: NCT03285308
• Lead Sponsor: Allergan

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 available

Study Timeline

• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-18
• Study Start: 2017-09-29
• Primary Completion: 2020-07-08
• Study Completion: 2020-07-08
• Status Verified: 2021-07
• Results First Submitted: 2021-07-08
• Results First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Results First Posted: 2021-07-29
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 336

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	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.
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	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	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.
Number of Participants With Clinically Meaningful Trends for Vital Signs	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.
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	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.
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit	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.
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period	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)	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	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 a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)	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 Clinically Significant Abnormal Electrocardiogram (ECG) Results	Up to 12 weeks	A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

Trial Locations

Locations (205)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Digestive Health Specialist of the South East; 🇺🇸 Dothan, Alabama, United States

Avant Research Associates; 🇺🇸 Huntsville, Alabama, United States

Synexus Clinical Research US, Inc.; 🇺🇸 Murray, Utah, United States

Central Arizona Medical Associates; 🇺🇸 Mesa, Arizona, United States

Phoenix Clinical LLC; 🇺🇸 Phoenix, Arizona, United States

Del Sol Research Management, LLC; 🇺🇸 Tucson, Arizona, United States

Preferred Research Partners, Inc.; 🇺🇸 Little Rock, Arkansas, United States

Arkansas Gastorenterology; 🇺🇸 North Little Rock, Arkansas, United States

Hope Clinical Research; 🇺🇸 Canoga Park, California, United States

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