A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis
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ClinicalTrials.gov Identifier: NCT03285308 |
Recruitment Status :
Recruiting
First Posted : September 18, 2017
Last Update Posted : January 24, 2019
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Condition or disease | Intervention/treatment | Phase |
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Gastroparesis Diabetes Mellitus | Drug: Relamorelin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 29, 2017 |
Estimated Primary Completion Date : | November 23, 2019 |
Estimated Study Completion Date : | November 23, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Relamorelin 10 μg
Relamorelin 10 μg injected subcutaneously twice daily for 12 weeks.
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Drug: Relamorelin
Relamorelin 10 μg injected twice daily for 12 weeks. |
Placebo Comparator: Placebo
Placebo injected twice daily for 12 weeks.
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Drug: Placebo
Placebo injected twice daily for 2 weeks or 12 weeks. |
- 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.
- 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.
- Percentage of Patients Meeting the Nausea Responder Criterion [ Time Frame: Baseline to Week 12 ]A Nausea Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.
- Percentage of Patients Meeting the Abdominal Pain Responder Criterion [ Time Frame: Baseline to Week 12 ]An Abdominal Pain Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.
- Percentage of Patients Meeting the Bloating Responder Criterion [ Time Frame: Baseline to Week 12 ]A Bloating Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.
- Percentage of Patients Meeting the Postprandial Fullness Responder Criterion [ Time Frame: Baseline to Week 12 ]A Postprandial Fullness Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites
- Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE) [ Time Frame: Baseline to Week 12 ]The number of patients who experienced one or more TEAE during the 12 week treatment period.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- History of an eating disorder (eg, anorexia nervosa, binge-eating, bulimia) in the past 5 years
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285308
Contact: Clinical Trials Registry Team | 877‐277‐8566 | IR-CTRegistration@allergan.com |

Study Director: | Wieslaw (Wes) Bochenek, MD, PhD | Allergan |
Additional Information:
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT03285308 History of Changes |
Other Study ID Numbers: |
RLM-MD-01 2017-002136-16 ( EudraCT Number ) |
First Posted: | September 18, 2017 Key Record Dates |
Last Update Posted: | January 24, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Diabetes Mellitus Gastroparesis Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Stomach Diseases |
Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations Signs and Symptoms |