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The Effects of RVX000222 on Glucose Metabolism in Individuals With Pre-diabetes

Sponsor
Resverlogix Corp (Industry)
Overall Status
Completed
CT.gov ID
NCT01728467
Collaborator
Baker Heart and Diabetes Institute (Other), Nucleus Network Ltd (Other)
20
Enrollment
1
Location
2
Arms
15.9
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study builds on data that high-density lipoprotein (HDL) has a number of potentially beneficial effects including directly modulating glucose metabolism through multiple mechanisms. The primary objective of this study is to determine the effects of RVX000222 on postprandial plasma glucose in male individuals with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), during a frequently sampled oral glucose tolerance test (OGTT).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 2 Randomised, Double-blind, Placebo-controlled, Cross-over Study for the Assessment of Glucose Metabolism Changes With RVX000222 in Individuals With Pre-diabetes
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: RVX000222, 200 mg daily

Drug: RVX000222
capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 31-35 days
Other Names:
  • RVX-208

    		•
    Placebo Comparator: Placebo

    Drug: Placebo, RVX000222
    capsule, administer with food, twice daily 10-12 hrs apart, 31-35 days
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in plasma glucose following treatment with RVX000222 compared to placebo [29-33 days]

      The change in postprandial plasma glucose, defined as area under the glucose curve (AUGC) during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo.

    Secondary Outcome Measures

    1. Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo [29-33 days]

      The change in indices of insulin secretion (β-cell function) and insulin sensitivity during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males aged 18-70 years, inclusive

    • Body mass index (BMI): 25-40 kg/m2

    • HDL cholesterol plasma levels: ≤1.4 mmol/L

    • Pre-diabetes: Either impaired fasting glucose (IFG; 6.1-6.9mmol/L) or impaired glucose tolerance (IGT; 2 hour OGTT glucose 7.8-11.0mmol/L, WHO classification) as measured at Visit 1

    • No current use or need for prescription or over-the-counter medication within four days of Visit 1

    • Have given signed informed consent to participate in the study

    Exclusion Criteria:

    • Identification of any other medical condition requiring immediate therapeutic intervention

    • Has received any over-the-counter medication including vitamins, herbal, or dietary supplements within four days of Visit 1 unless prior approval from the Investigator

    • Tobacco use within six months of Visit 1 (including cigarettes, pipes, chewing tobacco)

    • Elective surgery requiring general anaesthesia during the course of the study

    • Clinically significant heart disease at Visit 1

    • Clinically significant abnormal ECG at Visit 1

    • Evidence of renal impairment defined as serum creatinine >1.5 mg/dL (133 μmol/L) or creatinine clearance of <60 mL/min

    • History of hypertension or supine SBP >160mmHg or DBP >95mmHg as measured at Visit 1

    • Evidence of type 2 diabetes (fasting plasma glucose ≥7.0mmol/L; 2 hour OGTT glucose ≥11.1mmol/L)

    • Evidence of liver disease defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin >1.5 x upper limit of normal (ULN) at Visit 1

    • History of malignancy within past 5 years

    • History or evidence of drug or alcohol abuse within 12 months of Visit 1

    • Use of other investigational drugs and/or devices at the time of enrolment, or within 30 days of Visit 1

    • History of non-compliance to medical regimens or unwillingness to comply with the study protocol

    • Any condition that in the opinion of the Investigators would confound the evaluation and interpretation of the data

    • Persons directly involved in the execution of the protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baker IDI Heart and Diabetes Institute 75 Commercial Road, Melbourne Victoria Australia 3004

    Sponsors and Collaborators

    • Resverlogix Corp
    • Baker Heart and Diabetes Institute
    • Nucleus Network Ltd

    Investigators

    • Principal Investigator: Professor Bronwyn Kingwell, Baker Heart and Diabetes Institute
    • Principal Investigator: Dr. Stephen Duffy, Baker Heart and Diabetes Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Resverlogix Corp
    ClinicalTrials.gov Identifier:
    NCT01728467
    Other Study ID Numbers:
    • RVX222-CS-010
    • Alfred Study No. 409/12
    First Posted:
    Nov 19, 2012
    Last Update Posted:
    Apr 2, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Prediabetic State

    Study Results

    No Results Posted as of Apr 2, 2014