Clinical trial NCT01728467: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Lead sponsor: Resverlogix Corp
Sponsor class: INDUSTRY
Collaborators: name: Baker Heart and Diabetes Institute
name: Nucleus Network Ltd
First posted: 2012-11-19
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in plasma glucose following treatment with RVX000222 compared to placebo
timeFrame: 29-33 days
Secondary outcomes:
measure: Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo
timeFrame: 29-33 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker IDI Heart and Diabetes Institute 75 Commercial Road,
state: Victoria
Study officials:
affiliation: Baker Heart and Diabetes Institute
name: Professor Bronwyn Kingwell
role: PRINCIPAL_INVESTIGATOR
affiliation: Baker Heart and Diabetes Institute
name: Dr. Stephen Duffy
role: PRINCIPAL_INVESTIGATOR
References: