Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Primary Purpose
Diabetes Mellitus, Diabetes Mellitus Complications, Gastroparesis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RM-131
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Delayed Gastric Emptying, Gastroparesis, Gastrointestinal Motility Disorder
Eligibility Criteria
Inclusion Criteria:
- Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures.
- Type 1 or Type 2 diabetes mellitus with HbA1c ≤11% at screening.
- Diabetic gastroparesis defined as at least 3 months history of symptoms suggestive of gastroparesis on an ongoing basis.
- Average Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) > 2.6 during Visit 2.
- History of nausea and/or vomiting/emesis at least once a week during the 2 weeks prior to Visit 1.
- Delayed gastric emptying confirmed at screening by abnormal gastric emptying breath test (GEBT), defined as half-emptying time (t½) > 79 minutes.
- Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to Visit 2.
- No use of metoclopramide, erythromycin or anti-emetics for at least 2 weeks prior to Visit 2.
- Body mass index > 18 kg/m2.
- Female patients must have negative serum or urine pregnancy tests and must not be 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 one year since the last menstrual period]). Post-menopausal status will be confirmed by FSH.
Exclusion Criteria:
- Currently receiving parenteral feeding; presence of a nasogastric or other enteral tube for feeding or decompression.
- History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure.
- History of pyloric injection of botulinum toxin within 6 months of screening.
- Persistent daily vomiting.
- Patients with clinical suspicion of upper gastrointestinal obstruction must have been evaluated per standard of care, and obstruction ruled out before screening.
- Currently taking opiates.
- Currently taking GLP-1 and amylin analogs.
- Allergic or intolerant of egg, wheat, milk or algae, as these are components of the GEBT study meal.
- History of anorexia nervosa, binge-eating or bulimia within 5 years.
- ALT or AST > 2 X upper limit of normal during screening.
- 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 which 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, which in the opinion of the Investigator, including renal, hepatic or cardiopulmonary disease, or significant acute ECG abnormalities that would confound proper interpretation of the study or expose a patient to unacceptable risk.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
RM-131
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Effect of RM-131 on gastric emptying time
Change from baseline in gastric half-emptying time (t½)
Secondary Outcome Measures
Effect of RM-131 on symptoms of gastroparesis
Longitudinal change from baseline over time in daily symptom scores from a self administered daily symptom diary
Safety and tolerability of RM-131
Assessment of adverse events and clinical laboratory evaluations
Full Information
NCT ID
NCT01571297
First Posted
April 2, 2012
Last Updated
September 21, 2016
Sponsor
Motus Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01571297
Brief Title
Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Motus Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of RM-131 on gastric emptying, gastroparesis symptoms, and the safety and tolerability of RM-131 compared to placebo in patients with Type 1 and Type 2 diabetes mellitus and gastroparesis. The study is designed to evaluate the efficacy and safety of multiple dose regimens of RM-131. Study drug (RM-131 and placebo) will be administered subcutaneously in a blinded fashion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus Complications, Gastroparesis
Keywords
Diabetes Mellitus, Delayed Gastric Emptying, Gastroparesis, Gastrointestinal Motility Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RM-131
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RM-131
Intervention Description
Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given subcutaneously for 35 days
Primary Outcome Measure Information:
Title
Effect of RM-131 on gastric emptying time
Description
Change from baseline in gastric half-emptying time (t½)
Time Frame
Screening and Day 28
Secondary Outcome Measure Information:
Title
Effect of RM-131 on symptoms of gastroparesis
Description
Longitudinal change from baseline over time in daily symptom scores from a self administered daily symptom diary
Time Frame
Baseline, daily for 28 days, and Day 35
Title
Safety and tolerability of RM-131
Description
Assessment of adverse events and clinical laboratory evaluations
Time Frame
From Screening through Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures.
Type 1 or Type 2 diabetes mellitus with HbA1c ≤11% at screening.
Diabetic gastroparesis defined as at least 3 months history of symptoms suggestive of gastroparesis on an ongoing basis.
Average Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) > 2.6 during Visit 2.
History of nausea and/or vomiting/emesis at least once a week during the 2 weeks prior to Visit 1.
Delayed gastric emptying confirmed at screening by abnormal gastric emptying breath test (GEBT), defined as half-emptying time (t½) > 79 minutes.
Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to Visit 2.
No use of metoclopramide, erythromycin or anti-emetics for at least 2 weeks prior to Visit 2.
Body mass index > 18 kg/m2.
Female patients must have negative serum or urine pregnancy tests and must not be 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 one year since the last menstrual period]). Post-menopausal status will be confirmed by FSH.
Exclusion Criteria:
Currently receiving parenteral feeding; presence of a nasogastric or other enteral tube for feeding or decompression.
History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure.
History of pyloric injection of botulinum toxin within 6 months of screening.
Persistent daily vomiting.
Patients with clinical suspicion of upper gastrointestinal obstruction must have been evaluated per standard of care, and obstruction ruled out before screening.
Currently taking opiates.
Currently taking GLP-1 and amylin analogs.
Allergic or intolerant of egg, wheat, milk or algae, as these are components of the GEBT study meal.
History of anorexia nervosa, binge-eating or bulimia within 5 years.
ALT or AST > 2 X upper limit of normal during screening.
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 which 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, which in the opinion of the Investigator, including renal, hepatic or cardiopulmonary disease, or significant acute ECG abnormalities that would confound proper interpretation of the study or expose a patient to unacceptable risk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Development Officer
Organizational Affiliation
Rhythm Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Dothan
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
North Little Rock
State/Province
Arkansas
Country
United States
City
Concord
State/Province
California
Country
United States
City
Lomita
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Inverness
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Monroe
State/Province
Louisiana
Country
United States
City
Chevy Chase
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Farmington Hills
State/Province
Michigan
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Morehead City
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Chattanooga
State/Province
Tennessee
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Lubbock
State/Province
Texas
Country
United States
City
Burke
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32301137
Citation
Camilleri M, Lembo A, McCallum R, Tourkodimitris S, Kemps L, Miller MB, Bertelsen K, Iacob A. Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data. Aliment Pharmacol Ther. 2020 Jun;51(11):1139-1148. doi: 10.1111/apt.15711. Epub 2020 Apr 17.
Results Reference
derived
PubMed Identifier
27055601
Citation
Lembo A, Camilleri M, McCallum R, Sastre R, Breton C, Spence S, White J, Currie M, Gottesdiener K, Stoner E; RM-131-004 Trial Group. Relamorelin Reduces Vomiting Frequency and Severity and Accelerates Gastric Emptying in Adults With Diabetic Gastroparesis. Gastroenterology. 2016 Jul;151(1):87-96.e6. doi: 10.1053/j.gastro.2016.03.038. Epub 2016 Apr 4.
Results Reference
derived
Learn more about this trial
Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
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