DiabetesPhase 2NCT01728467
The Effects of RVX000222 on Glucose Metabolism in Individuals With Pre-diabetes
A Phase 2 study testing RVX000222 in people with Diabetes, run by Resverlogix Corp at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Diabetes
- What is being tested?
- RVX000222
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Baker IDI Heart and Diabetes Institute 75 Commercial Road,
Melbourne, Victoria, 3004
About this study
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
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).
- Conditions
- Diabetes
- Being tested
- RVX000222, Placebo, RVX000222
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVX000222Drug
Also called RVX-208
capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 31-35 days
Placebo, RVX000222Drug
Also called Placebo
capsule, administer with food, twice daily 10-12 hrs apart, 31-35 days
| Study group | Role | What they receive |
|---|---|---|
| RVX000222, 200 mg daily | Experimental | Not described Receives: Drug: RVX000222 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo, RVX000222 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 29-33 days
Secondary outcomes (1)
Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo
The change in indices of insulin secretion (β-cell function) and insulin sensitivity during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo.
Measured: 29-33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resverlogix Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baker Heart and Diabetes Institute, Nucleus Network Ltd
- Responsible party
- Sponsor
- Investigators
- Professor Bronwyn Kingwell, Principal investigator, Baker Heart and Diabetes InstituteDr. Stephen Duffy, Principal investigator, Baker Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728467
- Sponsor's protocol ID
- RVX222-CS-010
- Other IDs
- Alfred Study No. 409/12
- Status last verified
- Mar 2014
- First submitted
- 13 Nov 2012
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01728467
- Acronym / sponsor ID
- RVX222-CS-010
- Conditions
- Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Resverlogix CorpIndustry (pharma, biotech, devices)
- Collaborators
- Baker Heart and Diabetes Institute, Nucleus Network Ltd
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVX000222, 200 mg daily | Experimental | Drug: RVX000222 |
| Placebo | Placebo comparator | Drug: Placebo, RVX000222 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVX000222Also: RVX-208capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 31-35 days | Drug | RVX000222, 200 mg daily |
| Placebo, RVX000222Also: Placebocapsule, administer with food, twice daily 10-12 hrs apart, 31-35 days | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo
Time frame: 29-33 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Bronwyn Kingwell principal investigator
Baker Heart and Diabetes Institute
Dr. Stephen Duffy principal investigator
Baker Heart and Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVX000222 in people with Diabetes, run by Resverlogix Corp at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma glucose following treatment with RVX000222 compared to placebo (time frame: 29-33 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.