Type 2 DiabetesPhase 3NCT00854503
Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients
A Phase 3 study testing Simvastatin and Rosuvastatin in people with Type 2 Diabetes and Diabetic Dyslipidemia, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Diabetic Dyslipidemia
- What is being tested?
- Simvastatin and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2008to Dec 2010
- Phase
- Phase 3
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes in good glycemic control, treated with metformin alone.
- Untreated dyslipidemia.
- BMI <30.
Who cannot join
- History of cancer.
- History of cardiovascular diseases.
- Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.
Trial locations and contacts
1 site in 1 country.
About this study
Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.
- Conditions
- Type 2 Diabetes, Diabetic Dyslipidemia
- Being tested
- Simvastatin, Rosuvastatin
- Keywords
- Statins administration in diabetic dyslipidemia
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
20 mg/day in one oral administration
RosuvastatinDrug
20 mg/day in one oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Active comparator | Simvastatin 20 mg/day Receives: Drug: Simvastatin |
| Rosuvastatin | Active comparator | Rosuvastatin 20 mg/day Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance assessed by HbA1c and fasting glucose
Measured: 1, 6, 12 months
Secondary outcomes (1)
insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.
Measured: 1, 6, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854503
- Sponsor's protocol ID
- 131/08
- Status last verified
- Jan 2011
- First submitted
- 2 Mar 2009
- Last updated
- 12 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients
- ClinicalTrials.gov ID
- NCT00854503
- Acronym / sponsor ID
- 131/08
- Conditions
- Type 2 Diabetes, Diabetic Dyslipidemia
- Keywords
- Statins administration in diabetic dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Mar 2009 (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.
Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Active comparator | Drug: SimvastatinSimvastatin 20 mg/day |
| Rosuvastatin | Active comparator | Drug: RosuvastatinRosuvastatin 20 mg/day |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes in good glycemic control, treated with metformin alone.
- Untreated dyslipidemia.
- BMI <30.
Key exclusion criteria (3 listed)
- History of cancer.
- History of cardiovascular diseases.
- Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.
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 |
|---|---|---|
| Simvastatin20 mg/day in one oral administration | Drug | Simvastatin |
| Rosuvastatin20 mg/day in one oral administration. | Drug | Rosuvastatin |
Primary outcome
Glucose tolerance assessed by HbA1c and fasting glucose
Time frame: 1, 6, 12 months
1 secondary outcome
insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.
Time frame: 1, 6, 12 months.
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 12 May 2011.
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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?
A Phase 3 study testing Simvastatin and Rosuvastatin in people with Type 2 Diabetes and Diabetic Dyslipidemia, run by University of Rome Tor Vergata at 1 site in Italy.
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 3 inclusion and 3 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 12 May 2011. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Glucose tolerance assessed by HbA1c and fasting glucose (time frame: 1, 6, 12 months). 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 12 May 2011.