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Type 2 DiabetesPhase 3NCT00251680

Efficacy of Lapaquistat Acetate in Subjects Currently Treated With Lipid-Lowering Therapy.

A Phase 3 study testing Lapaquistat acetate and lipid-lowering therapy and Lipid-lowering therapy in people with Type 2 Diabetes, run by Takeda at 77 sites in 9 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with established lipid-lowering therapy in subjects with type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Lapaquistat acetate and lipid-lowering therapy and Lipid-lowering therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
77 sitesin 9 countries
Study dates
Oct 2005to May 2007
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females of childbearing potential who are sexually active must agree to use adequate contraception from screening throughout the duration of the study and for 30 days following the last dose.
  • Has a documented history of dyslipidemia with or without cardiovascular risk factors but without type 1 or 2 diabetes.
  • Is on a stable antidiabetic regimen, which may have included oral antidiabetic medication and/or insulin, for at least 3 months prior to Screening.
  • Prior to Randomization, the participant has a mean low density lipoprotein cholesterol level greater than or equal to 100 mg/dL and less than or equal to 190 mg/dL for 2 consecutive samples.
  • Prior to Randomization, the subject has mean triglyceride level greater than or equal to 400 mg/dL for 2 consecutive samples.
  • Is willing and able to comply with the recommended, standardized diet.

Who cannot join

  • Has annine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal, identified during screening.
  • Has a serum creatinine greater than 133 mmol/L, identified during screening.
  • Has a creatine kinase greater than 3 times the upper limit of normal, identified during screening.
  • Has active liver disease or jaundice.
  • Has taken any bile acid sequestrants [eg, cholestyramine], and intestinal cholesterol uptake inhibitors [eg, ezetimibe]) from 30 days before Screening until study completion or any fibrates for 6 weeks before Visit 1.
  • Has a previous history of cancer that has been in remission for less than 5 years prior to the first dose of study medication.
Show all 20Show fewer
  • Has an endocrine disorder, such as Cushing's syndrome, hyperthyroidism, or inappropriately treated hypothyroidism affecting lipid metabolism.
  • Has a history of myocardial infarction, angina pectoris, unstable angina, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal aortic aneurysm, coronary angioplasty, coronary or peripheral arterial surgery, or multiple risk factors that confer a 10-year risk for cardiovascular heart disease greater than 20% based on Framingham risk scoring.
  • Has a positive hepatitis B surface antigen or hepatitis C virus antibody test, as determined by medical history.
  • Has a positive human immunodeficiency virus status or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
  • Has received any investigational medication 30 days prior to screening, or is participating in an investigational study.
  • Has received lapaquistat acetate in a previous clinical study or as a therapeutic agent.
  • Has a history or presence of clinically significant food allergy that would prevent adherence to the specialized diet.
  • Has a known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia (familial dysbetalipoproteinemia).
  • Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
  • Has uncontrolled hypertension
  • Has had inflammatory bowel disease or any other malabsorption syndrome, or has had gastric bypass or any other surgical procedure for weight loss.
  • Has a history of drug abuse or a history of high alcohol intake within the previous 2 years.
  • Has type 1 or 2 diabetes mellitus.
  • Subject had a history of photoallergic or phototoxic reaction during treatment with a fibrate or ketoprofen.

Trial locations and contacts

77 sites in 9 countries.

77 sites in 9 countries

United States18 sites

  • Study site

    Artesia, California

  • Study site

    Aurora, Illinois

  • Study site

    Bristol, Tennessee

  • Study site

    Chesterfield, Missouri

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Dunwoody, Georgia

  • Study site

    Idaho Falls, Idaho

  • Study site

    Jacksonville, Florida

  • Study site

    Livonia, Michigan

  • Study site

    Margate City, New Jersey

  • Study site

    Melrose Park, Illinois

  • Study site

    Naperville, Illinois

  • Study site

    Overland Park, Kansas

  • Study site

    Richmond, Virginia

  • Study site

    San Antonio, Texas

  • Study site

    Trenton, New Jersey

  • Study site

    Tucson, Arizona

Other trials in United States

United Kingdom12 sites

  • Study site

    Bath

  • Study site

    Birmingham

  • Study site

    Blackpool

  • Study site

    Blantyre

  • Study site

    Chippenham

  • Study site

    Edinburgh

  • Study site

    Glasgow

  • Study site

    Harrow

  • Study site

    Hinckley

  • Study site

    Newport

  • Study site

    Nottingham

  • Study site

    Woolpit

Other trials in United Kingdom

Poland10 sites

  • Study site

    Krakow

  • Study site

    Leszno

  • Study site

    Lublin

  • Study site

    Niemodlin

  • Study site

    Ostrowiec Świętokrzyski

  • Study site

    Skierniewice

  • Study site

    Sroda Wlkp

  • Study site

    Starachowice

  • Study site

    Warsaw

  • Study site

    Zakopane

Other trials in Poland

Czechia9 sites

  • Study site

    Benešov

  • Study site

    Holice V Cechach

  • Study site

    Kladno

  • Study site

    Mladá Boleslav

  • Study site

    Olomouc

  • Study site

    Prague

  • Study site

    Trutnov

  • Study site

    Ústí nad Orlicí

  • Study site

    Zlín

Other trials in Czechia

Germany8 sites

  • Study site

    Berlin

  • Study site

    Bochum

  • Study site

    Chemnitz

  • Study site

    Dresden

  • Study site

    Frankfurt

  • Study site

    Görlitz

  • Study site

    Leipzig

  • Study site

    Nuremberg

Other trials in Germany

Slovakia7 sites

  • Study site

    Banská Bystrica

  • Study site

    Bojnice

  • Study site

    Bratislava

  • Study site

    Lučenec

  • Study site

    Prešov

  • Study site

    Šamorín

  • Study site

    Žilina

Other trials in Slovakia

South Africa6 sites

  • Study site

    Bloemfontein

  • Study site

    Cape Town

  • Study site

    Durban

  • Study site

    Lyttleton

  • Study site

    Pretoria

  • Study site

    Randburg

Other trials in South Africa

Finland4 sites

  • Study site

    Helsinki

  • Study site

    Hyvinkää

  • Study site

    Tampere

  • Study site

    Turku

Other trials in Finland

Estonia3 sites

  • Study site

    Pärnu

  • Study site

    Tallinn

  • Study site

    Tartu

Other trials in Estonia

About this study

Official title: A Placebo-Controlled, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg in Subjects With Type 2 Diabetes Currently Treated With Lipid-Lowering Therapy

The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with established lipid-lowering therapy in subjects with type 2 diabetes mellitus.

Read the detailed description

Diabetes mellitus is a recognized cause of secondary dyslipidemia, and is also independently considered to be a major cardiovascular risk factor requiring aggressive lipid-lowering treatment. Type 2 diabetes accounts for 85% to 90% of diabetes worldwide. It affects about 2% of the Caucasian population in most Westernized countries, and the prevalence rises with age to 10% in those over 70 years of age. Five percent or more of young- and middle-aged adults in some Asian or Afro-Caribbean groups in the United Kingdom have this condition. Approximately 12 million Americans have type 2 diabetes, and an estimated 20 million more have some degree of glucose intolerance. The greatest cause of mortality in type 2 diabetes is atherosclerotic vascular disease and its sequelae between 75% and 80% of adult subjects with diabetes die of macrovascular complications.

Lapaquistat acetate is a squalene synthase inhibitor currently under development at Takeda for the treatment of dyslipidemia. This study will evaluate the efficacy and safety of lapaquistat acetate co-administered with an established lipid-lowering therapy including atorvastatin, simvastatin, rosuvastatin, or fenofibrate in subjects with type 2 diabetes mellitus.

Conditions
Type 2 Diabetes
Being tested
Lapaquistat acetate and lipid-lowering therapy, Lipid-lowering therapy
Keywords
Hyperlipidemia, Drug Therapy
Medical subject headings
Diabetes Mellitus, Type 2, Hyperlipidemias

What participants receive

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

  • Lapaquistat acetate and lipid-lowering therapyDrug

    Also called TAK-475, Lipitor, Zocor, Crestor

    Lapaquistat acetate 50 mg, tablets, orally, once daily and stable lipid-lowering therapy for up to 24 weeks.

  • Lipid-lowering therapyDrug

    Also called Lipitor, Zocor, Crestor, Tricor

    Lapaquistat acetate placebo-matching tablets, tablets, orally, once daily and stable lipid-lowering therapy for up to 24 weeks.

Study groups in NCT00251680
Study groupRoleWhat they receive
Lapaquistat Acetate 50 mg QDExperimental(and stable lipid-lowering therapy)
Receives: Drug: Lapaquistat acetate and lipid-lowering therapy
Stable Lipid-lowering therapyActive comparatorNot described
Receives: Drug: Lipid-lowering therapy

What is being measured

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

  1. Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol

    Measured: Week 24 or Final Visit

Secondary outcomes (20)

  1. Change from Baseline in Triglycerides

    Measured: Week 24 or Final Visit

  2. Change from Baseline in Total Cholesterol

    Measured: Week 24 or Final Visit

  3. Change from Baseline in High Density Lipoprotein cholesterol

    Measured: Week 24 or Final Visit

  4. Change from Baseline in Very Low Density Lipoprotein cholesterol

    Measured: Week 24 or Final Visit

  5. Change from Baseline in apolipoprotein A1

    Measured: Week 24 or Final Visit

  6. Change from Baseline in apolipoprotein B

    Measured: Week 24 or Final Visit

  7. Change from Baseline in non- High Density Lipoprotein cholesterol

    Measured: Week 24 or Final Visit

  8. Change from Baseline in the ratio of Low Density Lipoprotein cholesterol/High Density Lipoprotein cholesterol

    Measured: Week 24 or Final Visit

  9. Change from Baseline in the ratio of Total Cholesterol/High Density Lipoprotein cholesterol

    Measured: Week 24 or Final Visit

  10. Change from Baseline in the ratio of apolipoprotein A1/apolipoprotein B

    Measured: Week 24 or Final Visit

  11. Change from Baseline in high-sensitivity C-reactive protein

    Measured: Week 24 or Final Visit

  12. Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 1.81 mmol/L (70 mg/dL)

    Measured: Week 24 or Final Visit

  13. Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 2.59 mmol/L (100 mg/dL)

    Measured: Week 24 or Final Visit

  14. Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 3.37 mmol/L (130 mg/dL)

    Measured: Week 24 or Final Visit

  15. Best corrected visual acuity

    Measured: Week 24 or Final Visit

  16. Adverse Events

    Measured: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit

  17. Clinical Laboratory Tests

    Measured: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit

  18. Vital Signs

    Measured: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit

  19. 12-lead Electrocardiogram

    Measured: Weeks 12 and 24 or Final Visit

  20. Physical Examination

    Measured: Week 24 or Final Visit

Timeline

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

  1. First posted10 Nov 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionMay 2007
  4. Study completionMay 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251680
Sponsor's protocol ID
TAK-475/EC304
Other IDs
2005-002316-24, U1111-1122-8281, 2005
Status last verified
May 2012
First submitted
8 Nov 2005
Last updated
24 May 2012
Results posted
No
Data monitoring committee
No

Publications

  • Stein EA, Bays H, O'Brien D, Pedicano J, Piper E, Spezzi A. Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia. Circulation. 2011 May 10;123(18):1974-85. doi: 10.1161/CIRCULATIONAHA.110.975284. Epub 2011 Apr 25.

    PubMed 21518985

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lapaquistat acetate and lipid-lowering therapy and Lipid-lowering therapy in people with Type 2 Diabetes, run by Takeda at 77 sites in 9 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 6 inclusion and 20 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 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, United Kingdom, Poland, Czechia, Germany and 4 more countries. 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?

Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol (time frame: Week 24 or Final Visit). 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 NCT00251680, 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 24 May 2012.

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