Non-insulin-dependent DiabetesDIOSNCT04007133
Statin Compliance of Patients With Non-insulin-dependent Diabetes
An observational study of Non-insulin-dependent Diabetes, run by Lille Catholic University at 1 site in France.
Trial summary
The diabetic population has an increased cardiovascular risk compared to the general population. Hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-insulin-dependent Diabetes
- What is being tested?
- Girerd test
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2018to 12 Jul 2018
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with non-insulin-dependent diabetes, taking statins for at least 1 month
Who may be able to join
- Major patients
- With non-insulin-dependent diabetes, taking statins for at least 1 month (to assess compliance)
- Hospitalized in the Diabetology Day Hospital of the Saint Philibert Hospital
- In capacity to answer the Girerd test
- Patient who has been informed and not opposed to the study
Who cannot join
- Patient's refusal to participate in the study
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Statin Compliance of Patients With Non-insulin-dependent Diabetes
The diabetic population has an increased cardiovascular risk compared to the general population.
Hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia.
Many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and as secondary prevention, to avoid recurrence.
However, compliance to these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness.
The purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.
Read the detailed description
The diabetic population has an increased cardiovascular risk compared to the general population. The mortality of people with diabetes due to ischemic heart disease is multiplied by 2.2, and when is due to cerebrovascular disease by 1.8 compared to those patients without diabetes. Hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia.
Statins have been shown to be effective in reducing the risk of cardiovascular events, each 1 mmol decrease in LDL cholesterol reduces the risk of cardiovascular events by 21% at 5 years.
Many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and for secondary prevention, to avoid recurrence.
However, compliance with these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness. Indeed, the persistence of statin use, one year after its prescription, is estimated at 70% in the general population. However, there are no data in the French population, and in particular on French diabetic patients for whom the cardiovascular risk is increased compared to the general population.
The purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.
- Conditions
- Non-insulin-dependent Diabetes
- Being tested
- Girerd test
- Keywords
- Non-insulin-dependent diabetes, Statins, Compliance
- Medical subject headings
- Diabetes Mellitus, Type 2, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girerd testOther
This is a simple and quick questionnaire, composed of 6 questions with a binary yes/no answer. It allows to assess the degree of compliance with the prescribed treatment to better identify the constraints related to the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Patients with non-insulin-dependent diabetes, taking statins for at least 1 month Receives: Other: Girerd test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate with statin measured by the Girerd test
This is a simple and quick questionnaire, composed of 6 questions with a binary yes/no answer. It allows to assess the degree of compliance with the prescribed treatment and thus to better identify the constraints related to the treatment. The score varies from 0 to 6 depending on the presence of "yes". 0 "yes": Good compliance, more than 3 "yes": non compliance.
Measured: Day 0
Secondary outcomes (2)
Compliance rate with statin according to the type of prevention
Type of prevention (primary/secondary) and compliance rate measured by the Girerd test
Measured: Day 0
Compliance rate with statin according to risk factors
Link between compliance rate measured by Girerd test and potential factors analyzed: age, sex, polypharmacy, duration of diabetes, no previous cardiovascular history, no prior dyslipidemia, blood LDL level, duration of statin intake, modalities of treatment preparation, understanding of the benefits of treatment
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start31 Jan 2018
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Why it stopped: The study was conducted in the context of a medical thesis with a deadline.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-insulin-dependent 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007133
- Sponsor's protocol ID
- RC-P0064
- Acronym
- DIOS
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Statin Compliance of Patients With Non-insulin-dependent Diabetes
- ClinicalTrials.gov ID
- NCT04007133
- Acronym / sponsor ID
- DIOS / RC-P0064
- Conditions
- Non-insulin-dependent Diabetes
- Keywords
- Non-insulin-dependent diabetes, Statins, Compliance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was conducted in the context of a medical thesis with a deadline.
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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.
The diabetic population has an increased cardiovascular risk compared to the general population.
Hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia.
Many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and as secondary prevention, to avoid recurrence.
However, compliance to these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness.
The purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.
Detailed description
The diabetic population has an increased cardiovascular risk compared to the general population. The mortality of people with diabetes due to ischemic heart disease is multiplied by 2.2, and when is due to cerebrovascular disease by 1.8 compared to those patients without diabetes. Hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia.
Statins have been shown to be effective in reducing the risk of cardiovascular events, each 1 mmol decrease in LDL cholesterol reduces the risk of cardiovascular events by 21% at 5 years.
Many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and for secondary prevention, to avoid recurrence.
However, compliance with these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness. Indeed, the persistence of statin use, one year after its prescription, is estimated at 70% in the general population. However, there are no data in the French population, and in particular on French diabetic patients for whom the cardiovascular risk is increased compared to the general population.
The purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Other: Girerd testPatients with non-insulin-dependent diabetes, taking statins for at least 1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with non-insulin-dependent diabetes, taking statins for at least 1 month
Key inclusion criteria (5 listed)
- Major patients
- With non-insulin-dependent diabetes, taking statins for at least 1 month (to assess compliance)
- Hospitalized in the Diabetology Day Hospital of the Saint Philibert Hospital
- In capacity to answer the Girerd test
- Patient who has been informed and not opposed to the study
Key exclusion criteria (2 listed)
- Patient's refusal to participate in the study
- Patient under guardianship or curatorship
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 |
|---|---|---|
| Girerd testThis is a simple and quick questionnaire, composed of 6 questions with a binary yes/no answer. It allows to assess the degree of compliance with the prescribed treatment to better identify the constraints related to the treatment. | Other | Diabetic patients |
Primary outcome
Compliance rate with statin measured by the Girerd test
Time frame: Day 0
This is a simple and quick questionnaire, composed of 6 questions with a binary yes/no answer. It allows to assess the degree of compliance with the prescribed treatment and thus to better identify the constraints related to the treatment. The score varies from 0 to 6 depending on the presence of "yes". 0 "yes": Good compliance, more than 3 "yes": non compliance.
2 secondary outcomes
Compliance rate with statin according to the type of prevention
Time frame: Day 0
Compliance rate with statin according to risk factors
Time frame: Day 0
Results and safety
The study was stopped early (reason given: The study was conducted in the context of a medical thesis with a deadline.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-insulin-dependent Diabetes, run by Lille Catholic University at 1 site in France.
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 2 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 17 Jul 2019. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: The study was conducted in the context of a medical thesis with a deadline.). 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?
Compliance rate with statin measured by the Girerd test (time frame: Day 0). 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 17 Jul 2019.