Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01728467