Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000620
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
1999-10-27
Brief Title:
Action to Control Cardiovascular Risk in Diabetes ACCORD
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Action to Control Cardiovascular Risk in Diabetes ACCORD
Status:
COMPLETED
Status Verified Date:
2014-11
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:
ACCORD
Brief Summary:
The purpose of this study is to prevent major cardiovascular events heart attack stroke or cardiovascular death in adults with type 2 diabetes mellitus using intensive glycemic control intensive blood pressure control and multiple lipid management
Detailed Description:
BACKGROUND
Currently about 17 million Americans have been diagnosed with diabetes and more than 90 percent of them have type 2 diabetes The number of people with this form of diabetes formerly known as adult onset or non-insulin dependent diabetes is growing rapidly By 2050 the number of Americans with diagnosed diabetes is projected to increase by 165 percent to 29 million of whom 27 million will have the type 2 form Cardiovascular disease CVD is the leading cause of death in people with type 2 diabetes these individuals die of CVD at rates two to four times higher than those who do not have diabetes They also experience more nonfatal heart attacks and strokes
Type 2 diabetes is associated with older age and is more common in those who are overweight or obese and have a family history of diabetes Women with a history of diabetes during pregnancy adults with impaired glucose tolerance people with a sedentary lifestyle and members of a minority raceethnicity are also at a greater risk for developing type 2 diabetes African Americans HispanicLatino Americans American Indians and some Asian Americans and Pacific Islanders are at particularly high risk for type 2 diabetes
DESIGN NARRATIVE
The three strategies tested in ACCORD included the following 1 Blood sugar - ACCORD was designed to determine whether lowering blood glucose to a level closer to normal than called for in current guidelines reduces CVD risk The study estimated effects on CVD of that level compared with a level that is usually targeted 2 Blood pressure - many people with type 2 diabetes have high blood pressure The blood pressure part of the trial was designed to determine the effects of lowering blood pressure in the context of good blood sugar control that is to determine whether lowering blood pressure to normal systolic pressure less than 120 mm Hg will better reduce CVD risk as compared to a usually-targeted level in current clinical practice ie below the definition of hypertension systolic pressure less than 140 mm Hg 3 Blood Fats - Many people with diabetes have high levels of LDL bad cholesterol and triglycerides as well as low levels of HDL good cholesterol ACCORD participants who are selected for this part of the trial were assigned to an intervention to improve blood fat levels This part of the study looked at the effects of lowering LDL cholesterol and blood triglycerides and increasing HDL cholesterol compared to an intervention that only lowers LDL cholesterol all in the context of good blood sugar control A drug from a class of drugs called fibrates was used to lower triglycerides and increase HDL cholesterol whereas a drug from the class of drugs called statins was used to lower LDL cholesterol
All ACCORD participants received blood sugar treatment from the study Based on the second trial Blood Pressure or Lipid they were assigned to participants also received their high blood pressure or cholesterol care from the study Study participants received all medication and treatments related to the study free of charge Individuals who selected for and consented to participate in the ACCORD study continued to see their personal physician for all other health care
In summary the ACCORD Study was a double 2x2 factorial design with factors consisting of intensive versus standard glycemic control intensive versus standard blood pressure control and blinded fenofibrate or placebo in combination with simvastatin to maintain desirable LDL-C levels All 10251 participants were randomized to the glycemic interventions a subgroup of 4733 participants who met the blood pressure entry criteria were randomized to the blood pressure interventions in one 2x2 trial and a distinct subgroup of 5518 participants who met the lipid entry criteria were randomized to the lipid interventions in the second 2x2 trial All participants had established type 2 diabetes and were recruited from 77 clinical centers in the United States 64 sites and Canada 13 sites
On February 6 2008 the National Heart Lung and Blood Institute NHLBI announced that participants in the intensive glycemia treatment would be transitioned to the ACCORD standard glycemic treatment approach due to higher mortality in the intensive treatment group terminating the experimental arm of the Glycemia Trial early The Blood Pressure and Lipid trials continued as designed to their planned termination in 2009
Currently about 17 million Americans have been diagnosed with diabetes and more than 90 percent of them have type 2 diabetes The number of people with this form of diabetes formerly known as adult onset or non-insulin dependent diabetes is growing rapidly By 2050 the number of Americans with diagnosed diabetes is projected to increase by 165 percent to 29 million of whom 27 million will have the type 2 form Cardiovascular disease CVD is the leading cause of death in people with type 2 diabetes these individuals die of CVD at rates two to four times higher than those who do not have diabetes They also experience more nonfatal heart attacks and strokes
Type 2 diabetes is associated with older age and is more common in those who are overweight or obese and have a family history of diabetes Women with a history of diabetes during pregnancy adults with impaired glucose tolerance people with a sedentary lifestyle and members of a minority raceethnicity are also at a greater risk for developing type 2 diabetes African Americans HispanicLatino Americans American Indians and some Asian Americans and Pacific Islanders are at particularly high risk for type 2 diabetes
DESIGN NARRATIVE
The three strategies tested in ACCORD included the following 1 Blood sugar - ACCORD was designed to determine whether lowering blood glucose to a level closer to normal than called for in current guidelines reduces CVD risk The study estimated effects on CVD of that level compared with a level that is usually targeted 2 Blood pressure - many people with type 2 diabetes have high blood pressure The blood pressure part of the trial was designed to determine the effects of lowering blood pressure in the context of good blood sugar control that is to determine whether lowering blood pressure to normal systolic pressure less than 120 mm Hg will better reduce CVD risk as compared to a usually-targeted level in current clinical practice ie below the definition of hypertension systolic pressure less than 140 mm Hg 3 Blood Fats - Many people with diabetes have high levels of LDL bad cholesterol and triglycerides as well as low levels of HDL good cholesterol ACCORD participants who are selected for this part of the trial were assigned to an intervention to improve blood fat levels This part of the study looked at the effects of lowering LDL cholesterol and blood triglycerides and increasing HDL cholesterol compared to an intervention that only lowers LDL cholesterol all in the context of good blood sugar control A drug from a class of drugs called fibrates was used to lower triglycerides and increase HDL cholesterol whereas a drug from the class of drugs called statins was used to lower LDL cholesterol
All ACCORD participants received blood sugar treatment from the study Based on the second trial Blood Pressure or Lipid they were assigned to participants also received their high blood pressure or cholesterol care from the study Study participants received all medication and treatments related to the study free of charge Individuals who selected for and consented to participate in the ACCORD study continued to see their personal physician for all other health care
In summary the ACCORD Study was a double 2x2 factorial design with factors consisting of intensive versus standard glycemic control intensive versus standard blood pressure control and blinded fenofibrate or placebo in combination with simvastatin to maintain desirable LDL-C levels All 10251 participants were randomized to the glycemic interventions a subgroup of 4733 participants who met the blood pressure entry criteria were randomized to the blood pressure interventions in one 2x2 trial and a distinct subgroup of 5518 participants who met the lipid entry criteria were randomized to the lipid interventions in the second 2x2 trial All participants had established type 2 diabetes and were recruited from 77 clinical centers in the United States 64 sites and Canada 13 sites
On February 6 2008 the National Heart Lung and Blood Institute NHLBI announced that participants in the intensive glycemia treatment would be transitioned to the ACCORD standard glycemic treatment approach due to higher mortality in the intensive treatment group terminating the experimental arm of the Glycemia Trial early The Blood Pressure and Lipid trials continued as designed to their planned termination in 2009
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01HC95178 | NIH | None | None |
| N01HC95179 | NIH | None | None |
| N01HC95180 | NIH | None | None |
| N01HC95181 | NIH | None | None |
| N01HC95182 | NIH | None | None |
| N01HC95183 | NIH | None | None |
| N01HC95184 | NIH | None | None |
| IAAY1HC9035 | OTHER_GRANT | None | None |
| IAAY1HC1010 | OTHER_GRANT | US Centers for Disease Control | httpsreporternihgovquickSearchN01HC95184 |