Tucson, Arizona 85712

  • Gastroparesis

Purpose:

The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1 and Type 2 diabetes mellitus and gastroparesis. Study drug (relamorelin and placebo) will be administered subcutaneously in a blinded fashion.


Criteria:

Inclusion Criteria: - Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) with stable glycemic control and Hemoglobin A1c (HbA1c) ≤11% at screening. - Diabetic gastroparesis (DG), defined as at least a 3-month history of symptoms suggestive of gastroparesis on an ongoing basis (e.g., vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain). - Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) score ≥2.6 at least once during the Screening Period (Visits 1-2). - At least 2 vomiting episodes during the ~2 weeks prior to the first screening visit (Visit 1), as ascertained by patient history. - Delayed Gastric Emptying (GE) confirmed at screening by abnormal Gastric Emptying Breath Test (GEBT), defined as GE half-time (t1/2) ≥79 minutes (the 80th percentile of normative data). At least 50% of patients enrolled will have a t1/2 ≥97 minutes (i.e., the 95th percentile). - Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to Visit 2 (daily adjustments of insulin doses are permitted). - No use of metoclopramide, erythromycin, domperidone, or other gastrointestinal (GI) motility agents, or anti-emetics for at least 2 weeks prior to Visit 2, and willingness to remain off these medications (except as used as part of protocol-specific rescue medication) during the course of the clinical trial. - Body mass index >18 kg/m2. - If female, has a negative serum or urine pregnancy test and is not lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female patients unable to bear children must have this documented in the electronic case report form (eCRF) (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of 1 year since the last menstrual period]). Post-menopausal status will be confirmed by measurement of follicle stimulating hormone (FSH). - Able to provide written informed consent prior to any study procedures and willing and able to comply with study procedures. Additional inclusion criteria for randomization after the 2-week single-blind placebo run-in period: - Compliance with the completion of the Diabetic Gastroparesis Symptom Severity Diary (DGSSD) and study drug injections, defined as approximately 80% diary completions and approximately 80% administration of injections, during the 2-week single-blind placebo run-in period. For those patients whose compliance is measured to be <80%, the final decision to randomize a patient will be made by the Investigator and the Sponsor (or designee). - At least one vomiting episode at any time during the 2-week single-blind placebo run-in period, as recorded in the DGSSD. Exclusion Criteria: - Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube [e.g., Percutaneous Endoscopic Gastrostomy (PEG) tube] for feeding or decompression. - History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure. (A history of diagnostic endoscopy is not exclusionary.) - History of pyloric injection of botulinum toxin within 6 months of screening. - Patients with clinical suspicion of upper GI obstruction (e.g., peptic stricture) must have been evaluated per standard of care and obstruction ruled out before screening. - Currently taking opiates, or expecting to use opiates during the course of the clinical trial. - Currently taking Glucagon-like peptide-1 (GLP-1) agonists, Sodium-glucose co-transporter 2 (SGLT2) inhibitors or pramlintide. - Allergic or intolerant of egg, wheat, milk, or algae, as these are components of the Gastric emptying breath test (GEBT) study meal. (Gluten-free crackers can be provided.) - History of anorexia nervosa, binge-eating, or bulimia within 5 years of screening. - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN) at Visit 1. - History of intestinal malabsorption or pancreatic exocrine disease. - Requires hemodialysis or has end-stage renal disease. - History of human immunodeficiency virus (HIV) infection. - Clinically significant neurologic or psychiatric disorders that are likely to impact compliance with protocol requirements. - Poor venous access or inability to tolerate venipuncture. - Participation in a clinical study within the 30 days prior to dosing in the present study. - Any other reason that, in the Investigator's opinion, would confound proper interpretation of the study or expose a patient to unacceptable risk, including renal, hepatic or cardiopulmonary disease, or significant acute electrocardiogram (ECG) abnormalities.


Study is Available At:


Original ID:

RM-131-009


NCT ID:

NCT02357420


Secondary ID:

2014-005623-27


Study Acronym:


Brief Title:

Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis


Official Title:

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Allergan


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

393


Enrollment Type:

Actual


Overall Contact Information

Official Name:Wieslaw Bochenek, MD
Study Director
Allergan

Study Dates

Start Date:January 29, 2015
Completion Date:June 9, 2016
Completion Type:Actual
Primary Completion Date:June 9, 2016
Primary Completion Type:Actual
Verification Date:June 2019
Last Changed Date:July 1, 2019
First Received Date:January 29, 2015
First Results Date:July 1, 2019

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time
Time Frame:Baseline (Day 1) to Week 12
Safety Issues:False
Description:GE was measured via the GEBT and was reported as a time to half (t1/2) of the theoretical total GE. GEBT is a non-radioactive stable isotope breath test intended for measurement of GE of solids in participants. A negative change from Baseline indicates im
Outcome Type:Secondary Outcome
Measure:Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)
Time Frame:7 days prior to Day 1 for Baseline to 7 days prior to Week 12
Safety Issues:False
Description:The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of DG (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Sever
Outcome Type:Primary Outcome
Measure:Change From Baseline to Week 12 in Weekly Vomiting Episodes
Time Frame:7 days prior to Day 1 for Baseline to 7 days prior to Week 12
Safety Issues:False
Description:Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, ab

Study Interventions

Intervention Type:Drug
Name:Relamorelin
Description:Double blind relamorelin was given subcutaneously BID for 12 weeks.
Arm Name:Relamorelin 10 μg
Other Name:RM-131
Intervention Type:Drug
Name:Placebo
Description:Placebo given subcutaneously for 12 weeks.
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:Relamorelin 10 μg
Description:Relamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
Study Arm Type:Experimental
Arm Name:Relamorelin 30 μg
Description:Relamorelin 30 μg was administered SC by injection BID for 12 weeks.
Study Arm Type:Experimental
Arm Name:Relamorelin 100 μg
Description:Relamorelin 100 μg was administered SC by injection BID for 12 weeks.
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo-matching relamorelin was administered SC by injection BID for 12 weeks.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Allergan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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