Diabetes MellitusPhase 4NCT00506961
Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia
A Phase 4 study testing Rosuvastatin and Simvastatin in people with Diabetes Mellitus and Dyslipidemia, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.
Trial summary
This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Dyslipidemia
- What is being tested?
- Rosuvastatin and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jun 2006to Jul 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female between the ages of 20-75 years.
- Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control.
- Diagnosed with type 2 diabetes mellitus.
- Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL
- Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no change in the category of anti-diabetic agents, but the dose is adjustable).
- All patients give written informed consent.
Who cannot join
- A history of hypersensitivity to statins.
- A history of rhabdomyolysis or hereditary muscle disorders.
- Insulin-treated patients.
- Patient with any conditions of acute or chronic pancreatitis.
- Creatine kinase ≧3-fold upper limit of normal (ULN).
- Patients with an estimated creatinine clearance (see note)≦30 ml/min or bilirubin ≧1.5-fold ULN, or chronic active hepatitis or liver function impairment (AST and ALT ≧3-fold ULN).
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- Overt proteinuria (repeat spot urine protein >300mg/dl by dipstick method).
- Patients are taking cyclosporine.
- A history of homozygous familial hypercholesterolemia or familial dysbetalipoproteinemia.
- Patients with alcohol and drug abuse in past 3 years.
- Serious or unstable medical or psychological conditions.
- Hypothyroidism (TSH > 5 μIU/mL).
- In the investigator's opinion, continuation in the study would be detrimental to the patient's well-being or might confound the clinical trial.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taichung Veterans General Hospital
Taichung
Taipei Veterans General Hospital
Taipei
About this study
Official title: A Phase IV, Randomized, Open-label, Parallel-arm, Comparative and Forced- Titration Study to Compare the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Patients With Type 2 DM and Dyslipidemia
This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is superior to simvastatin 40 mg in achieving the combined goal of LDL-C (<100 mg/dL) and non-HDL-C (<130 mg/dL).
Read the detailed description
The duration of patient participation will be 18 weeks consisting of a 1-week screening period, a 5-week lead-in period, followed by a 12-week treatment period.
- Conditions
- Diabetes Mellitus, Dyslipidemia
- Being tested
- Rosuvastatin, Simvastatin
- Medical subject headings
- Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called crestor
10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks
SimvastatinDrug
Also called zocor
20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks Receives: Drug: Rosuvastatin |
| 2 | Active comparator | 20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment
Measured: 12 weeks
Secondary outcomes (3)
Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;
Measured: 4 weeks
Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12;
Measured: 12 weeks
Percentage of patients achieving the LDL-C goal of <70 mg/dL at Week;The mean percent change from baseline in lipid profile at week 4 and week 12;
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJun 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Chii-Min Hwu, MD, Principal investigator, Taipei Veterans General Hospital, TaiwanWayne H Sheu, MD,phD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506961
- Sponsor's protocol ID
- AZ-RSV-RT-01
- Status last verified
- Dec 2011
- First submitted
- 24 Jul 2007
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wu TH, Lee IT, Ho LT, Sheu WH, Hwu CM. Combined lipid goal attainment in patients with type 2 diabetes and dyslipidemia: A head-to-head comparative trial of statins. J Chin Med Assoc. 2022 Aug 1;85(8):831-838. doi: 10.1097/JCMA.0000000000000765. Epub 2022 Jun 20.
PubMed 35727095
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Open-label, Parallel-arm, Comparative and Forced- Titration Study to Compare the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Patients With Type 2 DM and Dyslipidemia
- ClinicalTrials.gov ID
- NCT00506961
- Acronym / sponsor ID
- AZ-RSV-RT-01
- Conditions
- Diabetes Mellitus, Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Jun 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 25 Jul 2007 (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 is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is superior to simvastatin 40 mg in achieving the combined goal of LDL-C (<100 mg/dL) and non-HDL-C (<130 mg/dL).
Detailed description
The duration of patient participation will be 18 weeks consisting of a 1-week screening period, a 5-week lead-in period, followed by a 12-week treatment period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Rosuvastatin10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks |
| 2 | Active comparator | Drug: Simvastatin20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female between the ages of 20-75 years.
- Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control.
- Diagnosed with type 2 diabetes mellitus.
- Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL
- Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no change in the category of anti-diabetic agents, but the dose is adjustable).
Key exclusion criteria (13 listed)
- A history of hypersensitivity to statins.
- A history of rhabdomyolysis or hereditary muscle disorders.
- Insulin-treated patients.
- Patient with any conditions of acute or chronic pancreatitis.
- Creatine kinase ≧3-fold upper limit of normal (ULN).
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 |
|---|---|---|
| RosuvastatinAlso: crestor10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks | Drug | 1 |
| SimvastatinAlso: zocor20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks | Drug | 2 |
Primary outcome
The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment
Time frame: 12 weeks
3 secondary outcomes
Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;
Time frame: 4 weeks
Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12;
Time frame: 12 weeks
Percentage of patients achieving the LDL-C goal of <70 mg/dL at Week;The mean percent change from baseline in lipid profile at week 4 and week 12;
Time frame: 12 weeks
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 6 Dec 2011.
- Derived from this study: PubMed 35727095Wu TH, Lee IT, Ho LT, Sheu WH, Hwu CM. Combined lipid goal attainment in patients with type 2 diabetes and dyslipidemia: A head-to-head comparative trial of statins. J Chin Med Assoc. 2022 Aug 1;85(8):831-838. doi: 10.1097/JCMA.0000000000000765. Epub 2022 Jun 20.
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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.
Chii-Min Hwu, MD principal investigator
Taipei Veterans General Hospital, Taiwan
Wayne H Sheu, MD,phD principal investigator
Taichung Veterans General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin and Simvastatin in people with Diabetes Mellitus and Dyslipidemia, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.
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 13 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 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 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?
The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment (time frame: 12 weeks). 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 NCT00506961, 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 6 Dec 2011.