DiabetesPhase 4NCT00299169
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
A Phase 4 study testing N of 1 Trials in people with Diabetes and Cardiovascular Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Cardiovascular Disease, Hyperlipidemia
- What is being tested?
- N of 1 Trials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Nov 2007
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of type 1 or 2 diabetes
- Age 18-80 years
- Indication for a statin by the 2003 Canadian Diabetes Association (CDA) Clinical Practice Guidelines
- Willingness to re-try a statin despite previous apparent intolerance
- Provision of signed informed consent
Who cannot join
- Contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (CK, AST, ALT >three times upper limit of normal), pregnancy or lactation
- Impaired renal function: severe renal insufficiency (creatinine clearance <30 ml/min)
- Presence of a condition such as malignancy for which the one-year prognosis is poor
- Inability of the patient to comply with the rigorous conditions of the trial
- Any other condition deemed to render the study harmful to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels.
Read the detailed description
Cholesterol lowering medications called "statins" decrease heart disease in people with diabetes but research shows that many patients are not taking these medications, sometimes because of side effects. In our experience, the side effects attributed to statin therapy are often subjective, non-specific, and not associated with objective evidence for a clinically important problem. The most common example is muscle cramps despite a normal CK level, but other symptoms include fatigue, GI intolerance, and neurological symptoms.
Traditionally, the effects of treatments are determined using randomized controlled trials. N of 1 trials minimize these biases through randomization, double-blinding, and multiple crossovers, and are therefore excellent tools to evaluate adverse effects of therapies when symptoms are non-specific and objective evidence for a causal relationship is ambiguous.
Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels. Patients in the n of 1 trials group will be given 1 month courses of either simvastatin or placebo. Patients in the group who are receiving statins according to standard practice will be given a prescription by the doctor in the usual way.
At the end of the study, we will determine if more patients participating in n of 1 trials group are taking statins compared to the patients in the conventional group and if this leads to lower cholesterol levels. We plan to use the results of this small feasibility study to test the methods and to plan a larger study on the same question.
- Conditions
- Diabetes, Cardiovascular Disease, Hyperlipidemia
- Being tested
- N of 1 Trials
- Keywords
- N of 1 trial, diabetes mellitus, HMG CoA Reductase Inhibitors, cardiovascular disease
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N of 1 TrialsBehavioural
Also called usual care
N of 1 Trials of statin therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | N of 1 trials of statin therapy Receives: Behavioral: N of 1 Trials |
| 2 | Other | usual care Receives: Behavioral: N of 1 Trials |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean LDL levels
Measured: end of study
Secondary outcomes (1)
the proportions of participants taking statins at the end of the trial
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startSep 2006
- Study completionNov 2007
Why it stopped: insufficient recruitment/enrollment
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.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Investigators
- Charlotte G McDonald, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299169
- Sponsor's protocol ID
- R-06-135
- Other IDs
- IRF-061-05
- Status last verified
- Sep 2006
- First submitted
- 2 Mar 2006
- Last updated
- 8 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT00299169
- Acronym / sponsor ID
- R-06-135
- Conditions
- Diabetes, Cardiovascular Disease, Hyperlipidemia
- Keywords
- N of 1 trial, diabetes mellitus, HMG CoA Reductase Inhibitors, cardiovascular disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment/enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 6 Mar 2006 (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.
Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels.
Detailed description
Cholesterol lowering medications called "statins" decrease heart disease in people with diabetes but research shows that many patients are not taking these medications, sometimes because of side effects. In our experience, the side effects attributed to statin therapy are often subjective, non-specific, and not associated with objective evidence for a clinically important problem. The most common example is muscle cramps despite a normal CK level, but other symptoms include fatigue, GI intolerance, and neurological symptoms.
Traditionally, the effects of treatments are determined using randomized controlled trials. N of 1 trials minimize these biases through randomization, double-blinding, and multiple crossovers, and are therefore excellent tools to evaluate adverse effects of therapies when symptoms are non-specific and objective evidence for a causal relationship is ambiguous.
Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels. Patients in the n of 1 trials group will be given 1 month courses of either simvastatin or placebo. Patients in the group who are receiving statins according to standard practice will be given a prescription by the doctor in the usual way.
At the end of the study, we will determine if more patients participating in n of 1 trials group are taking statins compared to the patients in the conventional group and if this leads to lower cholesterol levels. We plan to use the results of this small feasibility study to test the methods and to plan a larger study on the same question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: N of 1 TrialsN of 1 trials of statin therapy |
| 2 | Other | Behavioral: N of 1 Trialsusual care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Established diagnosis of type 1 or 2 diabetes
- Age 18-80 years
- Indication for a statin by the 2003 Canadian Diabetes Association (CDA) Clinical Practice Guidelines
- Willingness to re-try a statin despite previous apparent intolerance
- Provision of signed informed consent
Key exclusion criteria (5 listed)
- Contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (CK, AST, ALT >three times upper limit of normal), pregnancy or lactation
- Impaired renal function: severe renal insufficiency (creatinine clearance <30 ml/min)
- Presence of a condition such as malignancy for which the one-year prognosis is poor
- Inability of the patient to comply with the rigorous conditions of the trial
- Any other condition deemed to render the study harmful to the participant
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 |
|---|---|---|
| N of 1 TrialsAlso: usual careN of 1 Trials of statin therapy | Behavioural | 1, 2 |
Primary outcome
mean LDL levels
Time frame: end of study
1 secondary outcome
the proportions of participants taking statins at the end of the trial
Time frame: end of study
Results and safety
The study was stopped early (reason given: insufficient recruitment/enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2008.
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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.
Charlotte G McDonald, MD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N of 1 Trials in people with Diabetes and Cardiovascular Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Jan 2008. 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 Canada. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: insufficient recruitment/enrollment). Results are not available in the source record.
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?
mean LDL levels (time frame: end of study). 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 8 Jan 2008.