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

NCT ID: NCT01728467

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-03-31

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).

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RVX000222, 200 mg daily

Group Type: EXPERIMENTAL

RVX000222

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo, RVX000222

Intervention Type: DRUG

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

Interventions

RVX000222

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

Intervention Type: DRUG

Placebo, RVX000222

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

Intervention Type: DRUG

Other Intervention Names

RVX-208; Placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Baker Heart and Diabetes Institute

OTHER

Sponsor Role: collaborator

Nucleus Network Ltd

OTHER

Sponsor Role: collaborator

Resverlogix Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor Bronwyn Kingwell

Role: PRINCIPAL_INVESTIGATOR

Baker Heart and Diabetes Institute

Dr. Stephen Duffy

Role: PRINCIPAL_INVESTIGATOR

Baker Heart and Diabetes Institute

Locations

Baker IDI Heart and Diabetes Institute 75 Commercial Road,

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

Alfred Study No. 409/12

Identifier Type: OTHER

Identifier Source: secondary_id

RVX222-CS-010

Identifier Type: -

Identifier Source: org_study_id