Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309712
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2006-03-30
Brief Title:
Diabetes and Combined Lipid Therapy Regimen DIACOR Study
Sponsor:
Intermountain Health Care Inc
Organization:
Intermountain Health Care Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgdL 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 hypertriglyceridemialow 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 diabetesMany 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 gemfibrozilcerivastatin 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 4000 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
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 diabetesMany 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 gemfibrozilcerivastatin 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 4000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None