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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01728467
Recruitment Status : Completed
First Posted : November 19, 2012
Last Update Posted : April 2, 2014
Sponsor:
Collaborators:
Baker IDI Heart and Diabetes Institute
Nucleus Network Ltd
Information provided by (Responsible Party):
Resverlogix Corp

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
Diabetes Drug: RVX000222 Drug: Placebo, RVX000222 Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : November 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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 Name: RVX-208

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




Primary Outcome Measures :
  1. Change in plasma glucose following treatment with RVX000222 compared to placebo [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728467


Locations
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Australia, Victoria
Baker IDI Heart and Diabetes Institute 75 Commercial Road,
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Resverlogix Corp
Baker IDI Heart and Diabetes Institute
Nucleus Network Ltd
Investigators
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Principal Investigator: Professor Bronwyn Kingwell Baker IDI Heart and Diabetes Institute
Principal Investigator: Dr. Stephen Duffy Baker IDI Heart and Diabetes Institute

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Responsible Party: Resverlogix Corp
ClinicalTrials.gov Identifier: NCT01728467    
Other Study ID Numbers: RVX222-CS-010
Alfred Study No. 409/12 ( Other Identifier: Baker IDI Heart and Diabetes Institute )
First Posted: November 19, 2012    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases