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

Primary Purpose

Diabetes

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

RVX000222

Placebo, RVX000222

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Baker IDI Heart and Diabetes Institute 75 Commercial Road,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RVX000222, 200 mg daily

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in plasma glucose following treatment with RVX000222 compared to placebo

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

Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo

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.

Full Information

NCT ID

NCT01728467

First Posted

November 13, 2012

Last Updated

March 31, 2014

Sponsor

Resverlogix Corp

Collaborators

Baker Heart and Diabetes Institute, Nucleus Network Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01728467

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Resverlogix Corp

Collaborators

Baker Heart and Diabetes Institute, Nucleus Network Ltd

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RVX000222, 200 mg daily

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

RVX000222

Other Intervention Name(s)

RVX-208

Intervention Description

capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 31-35 days

Intervention Type

Drug

Intervention Name(s)

Placebo, RVX000222

Other Intervention Name(s)

Placebo

Intervention Description

capsule, administer with food, twice daily 10-12 hrs apart, 31-35 days

Primary Outcome Measure Information:

Title

Change in plasma glucose following treatment with RVX000222 compared to placebo

Description

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.

Time Frame

29-33 days

Secondary Outcome Measure Information:

Title

Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo

Description

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.

Time Frame

29-33 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Professor Bronwyn Kingwell

Organizational Affiliation

Baker Heart and Diabetes Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dr. Stephen Duffy

Organizational Affiliation

Baker Heart and Diabetes Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baker IDI Heart and Diabetes Institute 75 Commercial Road,

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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