MONDAY, March 19 (HealthDay News) -- A new type of medication
for type 2 diabetes helps to lower blood sugar levels when used in
concert with insulin and other diabetes drugs, new research
The medicine is called dapagliflozin, and average blood sugar
levels were lower in those taking the drug compared to those taking
a placebo; both groups in the trial also took insulin and other
diabetes medications. Daily insulin doses went down for those on
the drug, and body weight dropped slightly.
"This study looked at the effects of dapagliflozin treatment in people with type 2 diabetes with high blood sugars despite insulin treatment, and found it was effective at reducing blood sugar, body weight and blood pressure," said study author Dr. John Wilding, head of the department of obesity and endocrinology at the University Hospital Aintree in Liverpool, England.
"Possible disadvantages include a slightly higher risk of urine infections and genital fungal infections, although most of these responded well to standard treatment," he added.
Results of the study are published in the March 20 issue of the
Annals of Internal Medicine. The study was funded by AstraZeneca and Bristol-Meyers Squibb, two pharmaceutical companies who are collaborating in the development of dapagliflozin.
Type 2 diabetes affects the way your body metabolizes sugar. In
type 2 diabetes, the body either doesn't use the hormone insulin
effectively or it doesn't make enough insulin, according to the
U.S. National Library of Medicine. Insulin allows the body's cells
to convert sugar from food into fuel. If it isn't used well or
there's not enough insulin, blood sugar levels will rise. High
blood sugar levels can cause a number of serious health
consequences, including damage to the eyes, kidneys and blood
In some cases, type 2 diabetes can be controlled with lifestyle
changes, such as losing weight and exercising regularly. However,
most people need medications to control their blood sugar levels,
and many people need a combination of medications to lower their
Dapagliflozin is from a new class of type 2 diabetes medications
that work by blocking the ability of the kidneys to hold sugar.
This causes the kidneys to release sugar as waste in the urine.
Numerous clinical trials have found dapagliflozin to be
effective at lowering blood sugar levels. Despite this beneficial
effect, the U.S. Food and Drug Administration recently decided not
to approve dapagliflozin until more information is available about
its possible long-term side effects. The most significant concern
cited by the FDA was a potential increase in the rates of bladder
and breast cancer in people taking the drug.
Although the current trial wasn't long enough to look for
longer-term outcomes, such as cancer, Wilding said that the slight
increase in bladder and breast cancer was likely a chance finding.
But, he said, because there is concern, it's important to continue
surveillance for these cancers in future trials.
The current study was designed to see how the drug would work in
combination with insulin and other type 2 diabetes medications.
The researchers enrolled just over 800 people with type 2
diabetes who were already taking insulin to control their blood
sugar levels. In addition, the study volunteers could be taking up
to two more blood sugar-lowering medications.
Study participants were randomly assigned to one of four
treatment groups. They received either a placebo, or one of three
doses of dapagliflozin (2.5, 5 or 10 milligrams) daily.
After 24 weeks of treatment, people in the dapagliflozin group
lowered their average hemoglobin A1C level between 0.79 percent to
0.96 percent compared with a 0.39 percent reduction in those on
placebo. Hemoglobin A1C is about a three-month average blood sugar
level. People with diabetes are advised to keep their levels below
Insulin use also dropped for people taking the medication,
suggesting more effective blood sugar control. And, body weight
decreased between 2 pounds and 3.5 pounds for those taking the
medication. Weight increased by almost 1 pound for those on
placebo, according to the study.
In addition, the researchers found that both systolic and
diastolic blood pressure levels went down more for those on the
drug compared to those on placebo.
"In this study, dapagliflozin seemed to improve glucose control and lower the need for insulin, as well as cause some weight loss," said Dr. Sue Kirkman, senior vice president of medical affairs and community information of the American Diabetes Association.
"This is an interesting study on a new medication that's under development. It has a novel mechanism of action, but there have been some ongoing concerns about the safety of this class of medications, and none has been approved by the FDA yet," she noted.
Learn more about type 2 diabetes and currently approved
treatments from the
American Diabetes Association.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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