Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study

2014-08-27 03:45:23 | BioPortfolio


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.


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

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Type II Diabetes Mellitus


fenofibrate 160 mg and placebo, simvastatin 20 mg and placebo, fenofibrate 160 mg and simvastatin 20 mg


McKay Dee Hospital
United States




Intermountain Health Care, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:45:23-0400

Clinical Trials [8874 Associated Clinical Trials listed on BioPortfolio]

Comparative Efficacy and Safety Study of Intermittent Simvastatin Versus Fenofibrate in Hemodialysis

Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their dialysis sess...

Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and ...

A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipid

This is a double-blind, randomized study designed to compare the efficacy and safety of two fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin 145/40 ...

Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and ...

Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome

This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.

PubMed Articles [10157 Associated PubMed Articles listed on BioPortfolio]

Fenofibrate effects on carotid artery intima-media thickness in adults with type 2 diabetes mellitus: a FIELD substudy.

Dyslipidemia in type 2 diabetes contributes to an increased risk of cardiovascular disease. Fenofibrate, a lipid-regulating peroxisome proliferator-activated receptor-α (PPARα) agonist, has been sho...

Simvastatin attenuates the aberrant expression of angiogenic factors induced by glucose variability Simvastatin, glucose variability, angiogenic factors.

Over the last few years, studies have indicated that fluctuant hyperglycemia is very likely to increase the risk of cardiovascular complications of diabetes. Statins are widely used in diabetes for th...

Fenofibrate improves vascular endothelial function and contractility in diabetic mice.

Fenofibrate, a peroxisome proliferator-activated receptors α (PPARα) agonist, reduces vascular complications of diabetic patients but its protective mechanisms are not fully understood. Here we test...

Preparation and characterization of simvastatin/DMβCD complex and its pharmacokinetics in rats.

Simvastatin is poorly bioavailable because it is practically insoluble in water and shows dissolution rate-limited absorption. Solubilizing effects of several β-cyclodextrin (βCD) derivatives such a...

Simvastatin-related myopathy in shift workers: a report of two cases.

Background Simvastatin is a widely used drug for dyslipidemia treatment, and the best therapeutic effects are achieved at night time. Simvastatin administration has been associated with the developmen...

Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of ezetimibe and simvastatin that is used in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.

An antilipemic agent which reduces both CHOLESTEROL and TRIGLYCERIDES in the blood.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.

More From BioPortfolio on "Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study"

Quick Search


Relevant Topics

Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...

Hyperlipidemia - high cholesterol (hypercholesterolaemia)
Hyperlipidemia involves abnormally elevated levels of any or all lipids and/or lipoproteins in the blood. Lipids are transported in a protein capsule, the size of that capsule, or lipoprotein, determines its density. The lipoprotein density and type...

Searches Linking to this Trial