Type II Diabetes MellitusPhase 3NCT00309751
Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
A Phase 3 study testing Pitavastatin and Atorvastatin in people with Type II Diabetes Mellitus and Dyslipidemia, run by Kowa Research Europe at 35 sites in 6 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type II Diabetes Mellitus, Dyslipidemia
- What is being tested?
- Pitavastatin and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 35 sitesin 6 countries
- Study dates
- Dec 2005to Jun 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females (ages 18-75 years)
- Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
- Must have been following a restrictive diet
- Diagnosis of combined dyslipidemia
Who cannot join
- Homozygous familial hypercholesterolemia
- Conditions which may cause secondary dyslipidemia
- Uncontrolled diabetes mellitus
- Abnormal pancreatic, liver, or renal function
- Abnormal serum creatine kinase (CK) above the pre-specified level
- Significant heart disease
Trial locations and contacts
35 sites in 6 countries.
35 sites in 6 countries
Poland10 sites
Podlaski Osrodek Kardiologii
Bialystok
NZOZ GCP Dobra Praktyka Lekaska
Gruziadz
NZOZ Terapia Optima
Katowice
NZOZ Esculap, Przychodnia Lekary Rodzinnych
Łosice
NZOZ Centrum, Poradnia Kardiologiczna
Siedlce
Spec. Gab. Lek. Internistyczno-Kardiologicznly
Tarnów
Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
Tychy
Instytut Zywnosci i Zywienia
Warsaw
Lecznica PROSEN SMO
Warsaw
Szpital Wolski,im. Dr A. Gostynskiej
Warsaw
Netherlands8 sites
Andromed Breda
Breda
Andromed Eindhoven
Eindhoven
Andromed Noord
Groningen
Andromed Leiden
Leiden
Andromed Nijmegen
Nijmegen
Andromed Rotterdam
Rotterdam
Andromed Oost
Velp
Andromed Zoetermeer
Zoetermeer
Germany5 sites
Gemeinschaftspraxis am Bahnhof
Berlin-Spandau
Pharmakologisches Studienzentum Chemnitz
Chemnitz
Internistische Diabetische Schwerpunktpraxis Dr.
Frankfurt am Main
Internistische Gemeinschaftspraxis
Mainz
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
Messkirch
India5 sites
Bhagwan Mahaveer Jain Heart Centre
Bangalore
Sri Ramachandra Medical College Hospital
Chennai
Apollo Hospitals
Hyderabaad
CARE Group of Hospitals
Hyderabaad
PD Hinduja Hospital
Mumbai
United Kingdom4 sites
Synexus Reading Clinical Research Centre
Berkshire
Synexus Lancashire Clinical Research Centre
Lancashire
Synexus Merseyside Clinical Research Centre
Liverpool
Synexus Manchester Clinical Research Centre
Manchester
Denmark3 sites
CCBR Aalborg
Aalborg
CCBR A/S
Ballerup Municipality
CCBR Vejle
Vejle
About this study
Official title: Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.
- Conditions
- Type II Diabetes Mellitus, Dyslipidemia
- Being tested
- Pitavastatin, Atorvastatin
- Keywords
- Kowa, Type II Diabetes Mellitus, Combined Dyslipidemia, pitavastatin, NK-104, Atorvastatin
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Pitavastatin 4 mg QD
AtorvastatinDrug
Also called Lipitor
Atorvastatin 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin 4 mg QD | Experimental | Pitavastatin 4 mg once daily Receives: Drug: Pitavastatin |
| Atorvastatin 20 mg QD | Active comparator | Atorvastatin 20 mg once daily Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)
Measured: 12 weeks
Secondary outcomes (1)
Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target
Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks
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 posted3 Apr 2006 (estimated)
- Study startDec 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type II Diabetes MellitusStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dragos Budinski, Med Dr., Study director, Kowa Research Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309751
- Sponsor's protocol ID
- NK-104-305
- Status last verified
- Feb 2010
- First submitted
- 8 Dec 2005
- Last updated
- 23 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
- ClinicalTrials.gov ID
- NCT00309751
- Acronym / sponsor ID
- NK-104-305
- Conditions
- Type II Diabetes Mellitus, Dyslipidemia
- Keywords
- Kowa, Type II Diabetes Mellitus, Combined Dyslipidemia, pitavastatin, NK-104, Atorvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Kowa Research EuropeIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 3 Apr 2006 (estimated)
- Results
- Posted 18 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin 4 mg QD | Experimental | Drug: PitavastatinPitavastatin 4 mg once daily |
| Atorvastatin 20 mg QD | Active comparator | Drug: AtorvastatinAtorvastatin 20 mg once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females (ages 18-75 years)
- Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
- Must have been following a restrictive diet
- Diagnosis of combined dyslipidemia
Key exclusion criteria (6 listed)
- Homozygous familial hypercholesterolemia
- Conditions which may cause secondary dyslipidemia
- Uncontrolled diabetes mellitus
- Abnormal pancreatic, liver, or renal function
- Abnormal serum creatine kinase (CK) above the pre-specified level
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 |
|---|---|---|
| PitavastatinPitavastatin 4 mg QD | Drug | Pitavastatin 4 mg QD |
| AtorvastatinAlso: LipitorAtorvastatin 20 mg | Drug | Atorvastatin 20 mg QD |
Primary outcome
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: 12 weeks
Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)
1 secondary outcome
Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dragos Budinski, Med Dr. study director
Kowa Research Europe
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pitavastatin and Atorvastatin in people with Type II Diabetes Mellitus and Dyslipidemia, run by Kowa Research Europe at 35 sites in 6 countries.
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 4 inclusion and 6 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 23 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Poland, Netherlands, Germany, India, United Kingdom and 1 more country. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C) (time frame: 12 weeks). 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 23 Feb 2010.