Phase 2 Randomised, Double-blind, Placebo-controlled, Cross-over Study for the Assessment of Glucose Metabolism Changes With RVX000222 in Individuals With Pre-diabetes

Resverlogix Corp1 site in 1 country20 target enrollmentNovember 2012

ConditionsDiabetes

InterventionsRVX000222 Placebo, RVX000222

DrugsRVX000222 Placebo, RVX000222

Overview

Phase: Phase 2
Intervention: RVX000222
Conditions: Diabetes
Sponsor: Resverlogix Corp
Enrollment: 20
Locations: 1
Primary Endpoint: Change in plasma glucose following treatment with RVX000222 compared to placebo
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

March 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Resverlogix Corp

Responsible Party

Sponsor

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

Arms & Interventions

RVX000222, 200 mg daily

Intervention: RVX000222

Placebo

Intervention: Placebo, RVX000222

Outcomes

Primary Outcomes

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.