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Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rhythm Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01394055
First received: July 8, 2011
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and delayed gastric emptying.


Condition Intervention Phase
Diabetes Mellitus Type 1 and 2
Diabetes Mellitus Complications
Gastroparesis
Gastrointestinal Motility Disorder
 Drug: RM-131
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose, 2-Period Crossover Study to Evaluate the Pharmacodynamics of RM-131 Administered to Patients With Diabetic Gastroparesis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rhythm Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Pharmacodynamic (PD) effects of RM-131 on gastric emptying [ Time Frame: Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2 ] [ Designated as safety issue: No ]
    Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids)


Secondary Outcome Measures:
  • Safety and tolerability of RM-131 [ Time Frame: Day 1 and 2 after dosing in Period 1 and Day 1 and 2 after dosing in Period 2 ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • Pharmacokinetics (PK) of RM-131 [ Time Frame: Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2 ] [ Designated as safety issue: No ]
    Median T-max of RM-131 levels in patients with type 2 diabetes mellitus


Enrollment: 20
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RM-131 Drug: RM-131
100 μg subcutaneously once
Placebo Comparator: Placebo Drug: Placebo
Matching placebo volume subcutaneously once

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Able to provide written informed consent prior to any study procedures.
  • Diagnosis of Type 1 or 2 diabetic gastroparesis.
  • Controlled Type 1 or 2 diabetes mellitus (HbA1c <10.1%).
  • Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to Period 1 (daily adjustments of insulin doses are permitted).
  • Body mass index of 18-40 kg/m².

Key Exclusion Criteria:

  • Unable or unwilling to provide informed consent or to comply with study procedures.
  • History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure. (Note: history of diagnostic endoscopy is not exclusionary).
  • Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, poor renal or hepatic function, etc.
  • Any clinically significant abnormalities on screening laboratories as determined by the Investigator.
  • Abnormal 12-lead electrocardiogram (ECG), including evidence of acute myocardial or subendocardial ischemia and clinically significant arrhythmias or conduction abnormalities or blood pressure at screening except minor deviations deemed to be of no clinical significance by the Investigator.
  • Poor venous access or inability to tolerate venipuncture.
  • Acute GI illness within 48 hours of Period 1.
  • Positive pregnancy test.
  • 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, would confound proper interpretation of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394055

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Rhythm Pharmaceuticals, Inc.
Investigators
Principal Investigator: Michael Camilleri, MD Mayo Clinic
  More Information

No publications provided by Rhythm Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rhythm Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01394055     History of Changes
Other Study ID Numbers: RM-131-003
Study First Received: July 8, 2011
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Rhythm Pharmaceuticals, Inc.:
Diabetes Mellitus Type 1 and 2
Delayed Gastric Emptying
Gastroparesis
Gastrointestinal Motility Disorder

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Gastroparesis
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013