Type II Diabetes MellitusNCT00309712
Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study
A study testing fenofibrate 160 mg and simvastatin 20 mg in people with Type II Diabetes Mellitus and Mixed Dyslipidemia, run by Intermountain Health Care, Inc. at 2 sites in United States.
Trial summary
The primary study hypothesis of this study is to determine whether there is a greater percentage of patients achieving a triglyceride level of <200 mg/dL with the combination of simvastatin 20 mg and fenofibrate 160mg than with either simvastatin 20 mg monotherapy or fenofibrate 160mg monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes Mellitus, Mixed Dyslipidemia
- What is being tested?
- fenofibrate 160 mg and simvastatin 20 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2002to Sep 2006
- Phase
- Interventional
- 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
- Controlled Type n Diabetes Mellitus (HbAlc <9%)
- Baseline levels ofLDL-C >100 mg/dL
- HDL-C <40 mg/dL
- Triglycerides :::200mg/dL and :::500mg/dL
- ALT and AST levels :::30%above the ULN with no active liver disease and CK :::50%above the ULN
- Alcohol consumption <2 drinks per day and with a maximum intake of <10 drinks per week
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- Patients who are currently treated with pioglitazone (15 to 45 fig/day), rosiglitazone (2 to 8 fig/day), or metformin (500 mg to 2500 fig/day) as monotherapy or in combination with insulin or sulfonylureas must have been on a stable dose of these anti-diabetic agents for the previous 3 months
- Patients on warfarin or warfarin-like anticoagulants must agree to have their INRJPT levels drawn per standard of care by the local lab for adjustment of anticoagulant dosage
- The patient understands the requirements of the study, and voluntarily agrees to participate in the study and provides informed consent
Who cannot join
- Uncontrolled Type n Diabetes Mellitus (HbAlc >9%);
- Known history of CAD
- Known history of myopathy or rhabdomyolysis
- Known history of intolerance to statins or fibric acid derivatives
- The use of lipid lowering agents or treatments therapy including bile acid sequestrants, HMG-Co-A reductase inhibitors, fish oil, nicotinic acid (doses >200 mg/day) or niacin taken within 6 weeks prior to the eligibility for randomization visit or 8 weeks prior to the eligibility visit, if the patient is on fibrates
- Serum creatinine> 1.5 mg/elL. If serum creatinine is between 1.2 and 1.49 mg/elL, the calculated creatinine clearance using the Crockcroft/Gault [Crockcroft, 1976 #124] formula must be >50 ml/min to be included in this study
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- Formula for Males:
- CrCI= (140-age [years])x (body weight [kg]) (72) x (serum Cr [mg/elL])
- Formula for Females:
- CrCI=(140-age [years]) x (body weight [kg]) x 0.85 (72) x (serum Cr [mg/dL]) g. Active liver disease including viral hepatitis (hepatitis B or C) as determined by positive antibodies to core and surface antigen for hepatitis B, and positive antibodies for hepatitis C h. Uncontrolled hypertension (treated or untreated) with systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg i. Proteinuria as defined by >0.5 mg albumin per mg creatinine (if dipstick> 1+) or history of nephrotic syndrome j. Secondary hypercholesteremia due to hypothyroidism (TSH >6~U/mL) or nephrotic syndrome; Patients with a history of hypothyroidism, who are on a stable dose of thyroxine with normalized plasma thyroxine and TSH may be included k. Diagnosis of homozygous familial hypercholesteremia, or Types I or V hyperlipidemia 1. The concomitant use of cyclosporine; systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazadone, or HIV protease inhibitors are excluded. The concomitant use of systemic (pO or IV) glucocorticoids, and verapamil (other calcium channel blockers are acceptable), or the consumption oflarge amounts of grapefruitjuice (> 1 quart) are excluded. m. Known hypersensitivity to any component of HMG-CoA reductase inhibitors or fibrates including history of elevated liver or muscle function tests, jaundice, or hepatotoxicity or myopathy associated with these treatments n. History of partial ileal bypass o. Treatment with any other investigational drug within the previous 30 days Currently using illicit drugs; history of drug or alcohol abuse within the past 5 years Type 1 diabetes mellitus, hyperlipidemicpancreatitis or known presence of cholelithiasis (gallstones); Any therapy or condition that would pose a risk to the patient or make it difficult for the patient to comply with requirements of the study s. Participation in any other studies involving investigational or marketed products within 30 prior to entryin the study. .
- 1. Pregnantand/orlactatingwomen,andwomenof childbearingpotentialnot usingacceptablemeansof contraception.Womenof childbearingpotentialmustbe usingadequatemeasuresof contraception(as determinedby the investigator)to avoidpregnancyandshouldbe highlyunlikelyto conceiveduringthe study period. Womenof childbearingpotentialmusthavea negativepregnancytest at the timeof initialscreening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McKay Dee Hospital
Ogden, Utah, 84403
LDS Hospital
Salt Lake City, Utah, 84143
About this study
Official title: Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study: A Randomized, Double-Blind Study of Simvastatin, Fenofibrate, and Combined Fenofibrate and Simvastatin in Patients With Controlled Type II Diabetics Without Evidence of Coronary Disease
The primary study hypothesis of this study is to determine whether there is a greater percentage of patients achieving a triglyceride level of <200 mg/dL with the combination of simvastatin 20 mg and fenofibrate 160mg than with either simvastatin 20 mg monotherapy or fenofibrate 160mg monotherapy.
Read the detailed description
Diabetes is a strong risk factor for atherosclerosis and is often characterized by dyslipidemia with hypertriglyceridemia,low high-density lipoprotein (HDL), and modestly elevated low-density lipoprotein (LDL). Both HMG-CoA reductase inhibitors (statins) and fibrates improve lipoprotein metabolism and decrease coronary disease risk. Statins and fibrates affect different aspects of lipoprotein metabolism and each improve lipid metabolism complimentarily. Statins lower total cholesterol and LDL while fibrates decrease triglyceride concentrations and elevateHDL cholesterol. Since individual lipid parameters have been shown to be independent cardiovascular risk factors, it is especially important to target all lipid parameters to levels outlined in treatment guidelines.
The National Cholesterol Education Program Adult Treatment Panel ill (NCEP ill) guidelines have set target therapeutic levels for coronary heart disease (CHD) and CHD risk equivalents (including diabetes).Many patients, however, are not able to achieve optimal levels with a single lipid-controlling agent.
This is particularly evident among diabetics, who often have multiple dyslipidemias and are less likely to achieve effective lipid control.
Several small clinical trials have demonstrated that fibrate and statin dual therapy combine the specific effects of the two drugs by significantlyreducing total and LDL cholesterol while increasing HDL cholesterol, though problems are associated. Previous studies, conducted mainly with a gemfibrozil/cerivastatin combination, showed an increased incidence of side effects (myopathy, hepatotoxicity) and high cost. This problem was again addressed in a small study of74 patients randomized to combined or alternate-day simvastatin and fenofibrate therapy. Surprisingly, in this study, no cases of myopathy were reported, even among patients receiving combined simvastatin and fenofibrate therapy.
The Lipids in Diabetes Study (LDSH Study) examined the fenofibrate and cerivastatin combination in a large-scale trial of 4,000 patients. This study was stopped early because study treatment included cerivastatin, which was withdrawn from the United States market in 2001. Consequently, the results' utility will be limited in the United States.
Additional studies evaluating lipid therapies capable of meeting more aggressive treatment guidelines outlined in NCEP ill, especially among diabetic patients, are required. We propose a twelve-month study of simvastatin, micronized fenofibrate, and combination therapy among patients with controlled Type 2 diabetes mellitus. The primary objectives ofthis study will be to assess the safety and efficacy of combined micronized fenofibrate and simvastatin therapy versus micronized fenofibrate or simvastatin monotherapy. Secondary objectives will include evaluation of combined micronized fenofibrate and simvastatin therapy versus micronized fenofibrate or simvastatin monotherapy on novel lipid parameters and serological markers associated with significantly increased cardiovascular risk. The benefits of the study will be numerous. First, we will be able to detennine the efficacy of each treatment arm in achieving the more aggressive lipid level targets outlined in NCEP ill. Second, this trial, unlike previous studies, will assess the safety and efficacy of each treatment arm specifically among diabetic patients. Third, the length of therapy will allow adequate, yet efficient, evaluation of the tertiary endpoints, which include novel risk factors not previously assessed with combination therapy.
- Conditions
- Type II Diabetes Mellitus, Mixed Dyslipidemia
- Being tested
- fenofibrate 160 mg and placebo, simvastatin 20 mg and placebo, fenofibrate 160 mg and simvastatin 20 mg
- Keywords
- diabetes, combination lipid treatment, statin, fibrate, hypercholesteremia, mixed dyslipidemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenofibrate 160 mg and placeboDrug
simvastatin 20 mg and placeboDrug
fenofibrate 160 mg and simvastatin 20 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of patients achieving study goal oftriglycerides <200 mg/dL
Secondary outcomes (1)
Percent of patients achieving all study goals: LDL-C < 100 mg/dL, HDL-C:40 mg/dL, Triglycerides <200 mg/dL and the Percent of patients achieving non-HDL cholesterol <130 mg/dL
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 startAug 2002
- Study completionSep 2006
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Merck Sharp & Dohme LLC
- Investigators
- Joseph B Muhlestein, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309712
- Sponsor's protocol ID
- 128-009
- Status last verified
- Aug 2008
- First submitted
- 30 Mar 2006
- Last updated
- 21 Aug 2008
- Results posted
- No
Publications
Muhlestein JB, May HT, Jensen JR, Horne BD, Lanman RB, Lavasani F, Wolfert RL, Pearson RR, Yannicelli HD, Anderson JL. The reduction of inflammatory biomarkers by statin, fibrate, and combination therapy among diabetic patients with mixed dyslipidemia: the DIACOR (Diabetes and Combined Lipid Therapy Regimen) study. J Am Coll Cardiol. 2006 Jul 18;48(2):396-401. doi: 10.1016/j.jacc.2006.05.009. Epub 2006 May 24.
PubMed 16843192
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study: A Randomized, Double-Blind Study of Simvastatin, Fenofibrate, and Combined Fenofibrate and Simvastatin in Patients With Controlled Type II Diabetics Without Evidence of Coronary Disease
- ClinicalTrials.gov ID
- NCT00309712
- Acronym / sponsor ID
- 128-009
- Conditions
- Type II Diabetes Mellitus, Mixed Dyslipidemia
- Keywords
- diabetes, combination lipid treatment, statin, fibrate, hypercholesteremia, mixed dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Abbott, Merck Sharp & Dohme LLC
- Study start
- Aug 2002
- Study completion
- Sep 2006
- First posted
- 3 Apr 2006 (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.
The primary study hypothesis of this study is to determine whether there is a greater percentage of patients achieving a triglyceride level of <200 mg/dL with the combination of simvastatin 20 mg and fenofibrate 160mg than with either simvastatin 20 mg monotherapy or fenofibrate 160mg monotherapy.
Detailed description
Diabetes is a strong risk factor for atherosclerosis and is often characterized by dyslipidemia with hypertriglyceridemia,low high-density lipoprotein (HDL), and modestly elevated low-density lipoprotein (LDL). Both HMG-CoA reductase inhibitors (statins) and fibrates improve lipoprotein metabolism and decrease coronary disease risk. Statins and fibrates affect different aspects of lipoprotein metabolism and each improve lipid metabolism complimentarily. Statins lower total cholesterol and LDL while fibrates decrease triglyceride concentrations and elevateHDL cholesterol. Since individual lipid parameters have been shown to be independent cardiovascular risk factors, it is especially important to target all lipid parameters to levels outlined in treatment guidelines.
The National Cholesterol Education Program Adult Treatment Panel ill (NCEP ill) guidelines have set target therapeutic levels for coronary heart disease (CHD) and CHD risk equivalents (including diabetes).Many patients, however, are not able to achieve optimal levels with a single lipid-controlling agent.
This is particularly evident among diabetics, who often have multiple dyslipidemias and are less likely to achieve effective lipid control.
Several small clinical trials have demonstrated that fibrate and statin dual therapy combine the specific effects of the two drugs by significantlyreducing total and LDL cholesterol while increasing HDL cholesterol, though problems are associated. Previous studies, conducted mainly with a gemfibrozil/cerivastatin combination, showed an increased incidence of side effects (myopathy, hepatotoxicity) and high cost. This problem was again addressed in a small study of74 patients randomized to combined or alternate-day simvastatin and fenofibrate therapy. Surprisingly, in this study, no cases of myopathy were reported, even among patients receiving combined simvastatin and fenofibrate therapy.
The Lipids in Diabetes Study (LDSH Study) examined the fenofibrate and cerivastatin combination in a large-scale trial of 4,000 patients. This study was stopped early because study treatment included cerivastatin, which was withdrawn from the United States market in 2001. Consequently, the results' utility will be limited in the United States.
Additional studies evaluating lipid therapies capable of meeting more aggressive treatment guidelines outlined in NCEP ill, especially among diabetic patients, are required. We propose a twelve-month study of simvastatin, micronized fenofibrate, and combination therapy among patients with controlled Type 2 diabetes mellitus. The primary objectives ofthis study will be to assess the safety and efficacy of combined micronized fenofibrate and simvastatin therapy versus micronized fenofibrate or simvastatin monotherapy. Secondary objectives will include evaluation of combined micronized fenofibrate and simvastatin therapy versus micronized fenofibrate or simvastatin monotherapy on novel lipid parameters and serological markers associated with significantly increased cardiovascular risk. The benefits of the study will be numerous. First, we will be able to detennine the efficacy of each treatment arm in achieving the more aggressive lipid level targets outlined in NCEP ill. Second, this trial, unlike previous studies, will assess the safety and efficacy of each treatment arm specifically among diabetic patients. Third, the length of therapy will allow adequate, yet efficient, evaluation of the tertiary endpoints, which include novel risk factors not previously assessed with combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Controlled Type n Diabetes Mellitus (HbAlc <9%)
- Baseline levels ofLDL-C >100 mg/dL
- HDL-C <40 mg/dL
- Triglycerides :::200mg/dL and :::500mg/dL
- ALT and AST levels :::30%above the ULN with no active liver disease and CK :::50%above the ULN
Key exclusion criteria (11 listed)
- Uncontrolled Type n Diabetes Mellitus (HbAlc >9%);
- Known history of CAD
- Known history of myopathy or rhabdomyolysis
- Known history of intolerance to statins or fibric acid derivatives
- The use of lipid lowering agents or treatments therapy including bile acid sequestrants, HMG-Co-A reductase inhibitors, fish oil, nicotinic acid (doses >200 mg/day) or niacin taken within 6 weeks prior to the eligibility for randomization visit or 8 weeks prior to the eligibility visit, if the patient is on fibrates
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 |
|---|---|---|
| fenofibrate 160 mg and placebo | Drug | – |
| simvastatin 20 mg and placebo | Drug | – |
| fenofibrate 160 mg and simvastatin 20 mg | Drug | – |
Primary outcome
percent of patients achieving study goal oftriglycerides <200 mg/dL
1 secondary outcome
Percent of patients achieving all study goals: LDL-C < 100 mg/dL, HDL-C:40 mg/dL, Triglycerides <200 mg/dL and the Percent of patients achieving non-HDL cholesterol <130 mg/dL
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 21 Aug 2008.
- Results publication: PubMed 16843192Muhlestein JB, May HT, Jensen JR, Horne BD, Lanman RB, Lavasani F, Wolfert RL, Pearson RR, Yannicelli HD, Anderson JL. The reduction of inflammatory biomarkers by statin, fibrate, and combination therapy among diabetic patients with mixed dyslipidemia: the DIACOR (Diabetes and Combined Lipid Therapy Regimen) study. J Am Coll Cardiol. 2006 Jul 18;48(2):396-401. doi: 10.1016/j.jacc.2006.05.009. Epub 2006 May 24.
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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.
Joseph B Muhlestein, MD principal investigator
Intermountain Health Care, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fenofibrate 160 mg and simvastatin 20 mg in people with Type II Diabetes Mellitus and Mixed Dyslipidemia, run by Intermountain Health Care, Inc. at 2 sites in United States.
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 9 inclusion and 11 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 21 Aug 2008. 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 United States. 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.
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?
percent of patients achieving study goal oftriglycerides <200 mg/dL. 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 NCT00309712, 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 21 Aug 2008.