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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01728467




Registration number
NCT01728467
Ethics application status
Date submitted
13/11/2012
Date registered
19/11/2012
Date last updated
2/04/2014

Titles & IDs
Public title
The Effects of RVX000222 on Glucose Metabolism in Individuals With Pre-diabetes
Scientific 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
Secondary ID [1] 0 0
Alfred Study No. 409/12
Secondary ID [2] 0 0
RVX222-CS-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RVX000222
Treatment: Drugs - Placebo, RVX000222

Experimental: RVX000222, 200 mg daily -

Placebo Comparator: Placebo -


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

Treatment: Drugs: Placebo, RVX000222
capsule, administer with food, twice daily 10-12 hrs apart, 31-35 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in plasma glucose following treatment with RVX000222 compared to placebo
Timepoint [1] 0 0
29-33 days
Secondary outcome [1] 0 0
Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo
Timepoint [1] 0 0
29-33 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker IDI Heart and Diabetes Institute 75 Commercial Road, - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Resverlogix Corp
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Baker Heart and Diabetes Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Nucleus Network Ltd
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01728467
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Professor Bronwyn Kingwell
Address 0 0
Baker Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01728467