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

July 8, 2011
March 6, 2013
July 2011
November 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01394055 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus Type 1 and 2
  • Diabetes Mellitus Complications
  • Gastroparesis
  • Gastrointestinal Motility Disorder
  • Drug: RM-131
    100 μg subcutaneously once
  • Drug: Placebo
    Matching placebo volume subcutaneously once
  • Active Comparator: RM-131
    Intervention: Drug: RM-131
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01394055
RM-131-003
No
Rhythm Pharmaceuticals, Inc.
Rhythm Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Michael Camilleri, MD Mayo Clinic
Rhythm Pharmaceuticals, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP