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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728467
• Other study ID #: RVX222-CS-010
• Secondary ID: Alfred Study No.
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2012
• Last updated: March 31, 2014
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Resverlogix Corp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• RVX000222
capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 31-35 days
• Placebo, RVX000222
capsule, administer with food, twice daily 10-12 hrs apart, 31-35 days

Locations

Country	Name	City	State
Australia	Baker IDI Heart and Diabetes Institute 75 Commercial Road,	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Resverlogix Corp	Baker IDI Heart and Diabetes Institute, Nucleus Network Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo	The change in indices of insulin secretion (ß-cell function) and insulin sensitivity during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo.	29-33 days	No