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DiabetesPhase 4NCT00658463

Effects of Rosuvastatin on the, in Vivo, Kinetic of apoB and apoA1, Using Stable Isotopes, in Type 2 Diabetic Patients

A Phase 4 study testing Rosuvastatin in people with Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Statins have been shown to reduce significantly the risk for cardiovascular events in patients with type 2 diabetes and statin therapy is largely recommended in this high cardiovascular risk population. However, a residual cardiovascular risk is observed in patients with type 2 diabetes treated by statins. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Diabetes
What is being tested?
Rosuvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
1 siteFrance
Study dates
Jan 2006to Sep 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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of written informed consent
  • Type 2 diabetic patients (age: 30 to 75 years) treated by one or two oral agents at fixed dose (sulfonylureas, metformin, alpha glucosidase inhibitors) for at least 6 months
  • Fasting triglycerides >= 150 mg/dl
  • HDL-C < 40 mg/dl in men and < 50 mg/dl in women (NCEP ATPIII lipid criteria for the metabolic syndrome)
  • Patients not receiving hypolipidemic agents since at least 6 months
  • Diabetic patients with stable HbA1c during the last 6 months
  • Subjects willing to follow all study procedures including attendance at clinic for scheduled study visits and compliance with study treatment regimen

Who cannot join

  • HbA1c > 9 %
  • LDL-C > 190 mg/dl
  • Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia
  • Documented secondary hypercholesterolaemia of any cause
  • History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy
  • Pregnant women, women who are breast feeding and women of childbearing potential who are not using chemical or mechanical contraception (prescription oral contraceptives, abstinence, condoms with spermicide, surgical sterilisation, diaphragm with spermicide or intrauterine device) or have positive pregnancy test
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  • History of malignancy, except subjects who have been disease free for more than 10 years or whose only malignancy has been basal or squamous cell skin carcinoma. Women with a history of cervical dysplasia should be excluded unless 3 consecutive normal cervical smears have subsequently been recorded before entry into the study
  • History of alcohol and/or drug abuse
  • Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT * 2 times the ULN. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the subject must not be included in the study
  • Patient with acromegaly or Cushing syndrome
  • Patient receiving insulin treatment
  • Use of drugs known to affect lipid metabolism: corticoids, retinoids, antiproteases, estrogens, cyclosporin, glitazones, statins other than rosuvastatin, fibrates, cholestyramine, nicotinic acid, omega 3 or phytosterols
  • Renal impairment as defined by creatinine clearance < 30 ml/min.
  • Unstable angina or manifestation of severe atherosclerosis.
  • Uncontrolled hypertension defined as either resting diastolic blood pressure of >95mmHg or resting systolic blood pressure of >200 mmHg.
  • Unexplained serum CK > 3 times ULN (eg. not due to recent trauma, intramuscular injections, heavy exercise, etc).
  • Participation in another investigational drug trial within 4 weeks prior to randomization.
  • Subjects with serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the trial.
  • Subjects with serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the trial.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21000

Other trials in France

About this study

Official title: Effects of Rosuvastatin on the, in Vivo, Kinetic of VLDL apoB, IDL apoB, LDL apoB and HDL apoA1, Using Stable Isotopes, in Type 2 Diabetic Patients

Statins have been shown to reduce significantly the risk for cardiovascular events in patients with type 2 diabetes and statin therapy is largely recommended in this high cardiovascular risk population. However, a residual cardiovascular risk is observed in patients with type 2 diabetes treated by statins. This may be due to the fact that statins do not correct all lipid abnormalities associated with diabetic dyslipidaemia, such as hyperTG and low HDL-cholesterol.

Rosuvastatin is a statin which, in addition to its efficacy to reduce LDL-cholesterol, has been show to decrease significantly plasma triglycerides. However, the effects of rosuvastatin on triglyceride rich lipoproteins and HDL remains unknown. The purpose of this study is to analyze the effect rosuvastatin 20 mg on the metabolism of triglyceride rich lipoproteins and HDL in patients with Type 2 diabetes using and in vivo kinetic study of VLDL1-apoB,VLDL2-apoB,IDL-apoB and HDL-apoA1.

Read the detailed description

This is a randomized, double blinded, placebo-controlled, monocentric, cross-over study with two 6-week periods of placebo or rosuvastatin. Subjects will enter a one month placebo lead-in period after which they will be eligible for rosuvastatin 20 mg or placebo for two 6-week periods.

An in vivo kinetic study will be performed with stable isotopes (13C leucine) in type 2 diabetic patients (n=8) before and after a 6-week period of rosuvastatin (20mg) therapy. The study is design with a one-month steady state period with placebo then on a cross-over design with two 6-week periods of placebo or rosuvastatin (20 mg. An in vivo kinetic study will be performed at the end of each 6-week period.

The kinetic studies performed, in each patient, will assess the production rates and fractional rates of VLDL1-apoB, VLDL2-apoB, IDL-apoB, LDL-apoB and HDL-apoA-I.

Conditions
Diabetes
Being tested
Rosuvastatin, Placebo
Keywords
Diabetes, Triglycerides, HDL-cholesterol, kinetic, rosuvastatin
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RosuvastatinDrug

    Also called CRESTOR (brand name for rosuvastatin)

    rosuvastatin 20 mg/day during 6 weeks versus placebo during 6 weeks in a cross-over design

  • PlaceboDrug

    Placebo

Study groups in NCT00658463
Study groupRoleWhat they receive
1ExperimentalThe study is designed with a one-month steady state period with placebo then on a cross-over design with two 6-week periods of placebo or rosuvastatin (20 mg). An in vivo kinetic study will be performed at the end of each 6-week period.
Receives: Drug: Rosuvastatin
2Placebo comparatorThe study is designed with a one-month steady state period with placebo then on a cross-over design with two 6-week periods of placebo or rosuvastatin (20 mg). An in vivo kinetic study will be performed at the end of each 6-week period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fractional Catabolic Rates (FCR)of VLDL1-apoB, VLDL2-apoB, IDL-apoB, LDL-apoB and HDL-apoA-I

    Measured: At the end of each treatment period (rosuvastatin or placebo)

Secondary outcomes (1)

  1. Production Rates (PR) of VLDL1-apoB, VLDL2-apoB, IDL-apoB, LDL-apoB and HDL-apoA-I

    Measured: At the end of each treatment period (rosuvastatin or placebo)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2008 (estimated)
  2. Study startJan 2006
  3. Primary completionJun 2007
  4. Study completionSep 2007

Resources

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00658463
Sponsor's protocol ID
AFSSAPS 041348
Status last verified
Mar 2008
First submitted
2 Apr 2008
Last updated
15 Apr 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Verges B, Florentin E, Baillot-Rudoni S, Monier S, Petit JM, Rageot D, Gambert P, Duvillard L. Effects of 20 mg rosuvastatin on VLDL1-, VLDL2-, IDL- and LDL-ApoB kinetics in type 2 diabetes. Diabetologia. 2008 Aug;51(8):1382-90. doi: 10.1007/s00125-008-1046-4. Epub 2008 Jun 5.

    PubMed 18535816

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rosuvastatin in people with Diabetes, run by Centre Hospitalier Universitaire Dijon 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 7 inclusion and 19 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 15 Apr 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 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. 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 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 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?

Fractional Catabolic Rates (FCR)of VLDL1-apoB, VLDL2-apoB, IDL-apoB, LDL-apoB and HDL-apoA-I (time frame: At the end of each treatment period (rosuvastatin or placebo)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00658463, which also lists 1 linked publication.

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 15 Apr 2008.

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