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

NCT01728467 | Completed Phase 2

• 2 other identifiers: RVX222-CS-010Alfred Study No. 409/12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  29-33 days

Secondary Outcomes (1)

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

  29-33 days

Study Arms (2)

RVX000222, 200 mg daily

EXPERIMENTAL

Drug: RVX000222

Placebo

PLACEBO COMPARATOR

Drug: Placebo, RVX000222

Interventions

RVX000222 DRUG

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

Also known as: RVX-208

RVX000222, 200 mg daily

Placebo, RVX000222 DRUG

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Resverlogix Corp: lead
• Baker Heart and Diabetes Institute: collaborator
• Nucleus Network Ltd: collaborator

Study Sites (1)

Baker IDI Heart and Diabetes Institute 75 Commercial Road,

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

apabetalone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Professor Bronwyn Kingwell

  Baker Heart and Diabetes Institute

  PRINCIPAL INVESTIGATOR

• Dr. Stephen Duffy

  Baker Heart and Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 19, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 2, 2014

Record last verified: 2014-03

Locations

AU (1)