Skip to content
My WebMD Sign In, Sign Up

Diabetes Health Center

Font Size

Deaths Prompt Halt in Diabetes Study

Study of Intensive Treatment of Diabetes Curtailed Because of Increased Death Rates
By
WebMD Health News
Reviewed by Louise Chang, MD

Feb. 6, 2008 -- Researchers abruptly halted part of a major diabetes trial Wednesday because of increased death rates in patients who got intensive treatment to lower their blood sugar.

Researchers say they do not know the reasons for the deaths, which occurred in type 2 diabetes patients getting intensive treatment with multiple drugs for blood pressure, high cholesterol, and blood sugar. Parts of the trial evaluating less intensive treatment would continue, they say.

"We did not anticipate the findings and in that sense we were surprised," says Elizabeth G. Nabel, MD, director of the National Heart, Lung and Blood Institute, an arm of the National Institutes of Health that is leading the trial.

The trial, known as the "Action to Control Cardiovascular Risk in Diabetes" trial, or ACCORD, was started in 2001 to test whether intensively lowering blood sugar in high-risk type 2 diabetes patients cuts their risk of cardiovascular events like heart attacks and strokes.

But part of the 10,251-person trial was stopped after researchers saw 257 deaths in the group of patients undergoing intensive treatment to lower blood sugar control down to levels below current recommendations. That was compared with 203 patients who died while in standard, less intensive treatment.

The difference added up to three deaths per 1,000 patients over four years, investigators say.

Intensive Blood Sugar Treatment

Researchers have long theorized that more aggressive blood sugar treatment would help high-risk type 2 diabetes patients avoid cardiovascular problems. Other studies have shown that blood glucose control lowers the risk of eye, nerve, and kidney complications that often follow diabetes.

"We obviously were surprised. We were hoping for a positive outcome, but the reason we do this research is that we don't know that," says William T. Friedewald, MD, a professor of medicine at Columbia University and chairman of the study's steering committee.

The study, conducted at 77 centers in the U.S. and Canada, divided patients into two main groups. One group got standard diet, exercise, and drug treatment designed to lower a measurement of blood sugar control called hemoglobin A1c to between 7% and 7.9%. A second group got intensive treatment designed to drop A1c even further to under 6%, the levels seen in most adults without diabetes.

Patients also got drug treatment for high blood pressure, high cholesterol, and other problems.

Despite the higher death rate in the intensive-treatment group, researchers stressed that those rates were still lower than in the general diabetes population.

The results raised concerns that the diabetes drug Avandia my have played a role in the increased deaths. The drug has been under intense scrutiny by the FDA because of recent evidence that it may boost the risk of cardiovascular events.

Avandia was used in the trial, but Friedewald says a preliminary analysis could not connect the drug to increased deaths.

"At this time we have found no link, and thus the use of rosiglitazone does not seem to explain the increased mortality," he says.

Is This Normal? Get the Facts Fast!

Check Your Blood Sugar Level Now
What type of diabetes do you have?
Your gender:

Get the latest Diabetes newsletter delivered to your inbox!


or
Answer:
Low
0-69
Normal
70-130
High
131+

Your level is currently

If the level is below 70 or you are experiencing symptoms such as shaking, sweating or difficulty thinking, you will need to raise the number immediately. A quick solution is to eat a few pieces of hard candy or 1 tablespoon of sugar or honey. Recheck your numbers again in 15 minutes to see if the number has gone up. If not, repeat the steps above or call your doctor.

People who experience hypoglycemia several times in a week should call their health care provider. It's important to monitor your levels each day so you can make sure your numbers are within the range. If you are pregnant always consult with your health care provider.

Congratulations on taking steps to manage your health.

However, it's important to continue to track your numbers so that you can make lifestyle changes if needed. If you are pregnant always consult with your physician.

Your level is high if this reading was taken before eating. Aim for 70-130 before meals and less than 180 two hours after meals.

Even if your number is high, it's not too late for you to take control of your health and lower your blood sugar.

One of the first steps is to monitor your levels each day. If you are pregnant always consult with your physician.

Did You Know Your Lifestyle Choices
Affect Your Blood Sugar?

Use the Blood Glucose Tracker to monitor
how well you manage your blood sugar over time.

Get Started

This tool is not intended for women who are pregnant.

Start Over

Step:  of 

Today on WebMD

Diabetic tools
Symptoms, diagnosis, treatment, and more.
woman flexing muscles
10 strength training exercises.
 
Blood sugar test
12 practical tips.
Tom Hanks
Stars living with type 1 or type 2.
 
Woman serving fast food from window
Video
Can Vinegar Treat Diabetes
Video
 
Middle aged person
Tool
are battery operated toothbrushes really better
Video
 

Prediabetes How to Prevent Type 2 Diabetes
Article
type 2 diabetes
Slideshow
 
food fitness planner
Tool
Are You at Risk for Dupuytrens Contracture
Article