Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis

Sponsor
Motus Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01571297
Collaborator
(none)
204
30
2
17
6.8
0.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: RM-131

Drug: RM-131
Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.

Placebo Comparator: Placebo

Drug: Placebo
Placebo given subcutaneously for 35 days

Outcome Measures

Primary Outcome Measures

  1. Effect of RM-131 on gastric emptying time [Screening and Day 28]

    Change from baseline in gastric half-emptying time (t½)

Secondary Outcome Measures

  1. Effect of RM-131 on symptoms of gastroparesis [Baseline, daily for 28 days, and Day 35]

    Longitudinal change from baseline over time in daily symptom scores from a self administered daily symptom diary

  2. Safety and tolerability of RM-131 [From Screening through Day 35]

    Assessment of adverse events and clinical laboratory evaluations

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dothan Alabama United States
2 Tucson Arizona United States
3 North Little Rock Arkansas United States
4 Concord California United States
5 Lomita California United States
6 Los Angeles California United States
7 Torrance California United States
8 Hialeah Florida United States
9 Inverness Florida United States
10 Miami Florida United States
11 West Palm Beach Florida United States
12 Wichita Kansas United States
13 Monroe Louisiana United States
14 Chevy Chase Maryland United States
15 Boston Massachusetts United States
16 Farmington Hills Michigan United States
17 Jackson Mississippi United States
18 Lebanon New Hampshire United States
19 Albuquerque New Mexico United States
20 Morehead City North Carolina United States
21 Raleigh North Carolina United States
22 Wilmington North Carolina United States
23 Winston-Salem North Carolina United States
24 Portland Oregon United States
25 Chattanooga Tennessee United States
26 Germantown Tennessee United States
27 Dallas Texas United States
28 Lubbock Texas United States
29 Burke Virginia United States
30 Norfolk Virginia United States

Sponsors and Collaborators

  • Motus Therapeutics, Inc.

Investigators

  • Study Director: Chief Development Officer, Rhythm Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Motus Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01571297
Other Study ID Numbers:
  • RM-131-004
First Posted:
Apr 5, 2012
Last Update Posted:
Sep 23, 2016
Last Verified:
Sep 1, 2016

Study Results

No Results Posted as of Sep 23, 2016